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Abbott K, Seton N, Kaur G, Zhao J, Jones M, Singh K. Long-term (12 months) vs. short-term (<12 months) dual antiplatelet therapy post-percutaneous coronary intervention with drug-eluting stents: a critical appraisal and systematic review. Coron Artery Dis 2025; 36:312-325. [PMID: 40326591 DOI: 10.1097/mca.0000000000001483] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/07/2025]
Abstract
BACKGROUND A growing body of evidence supports short-term DAPT as safe and efficacious following PCI with DES. However, methodological criticism of RCTs has led to caution when translating results into clinical practice. This study aimed to critically appraise the methodological rigour of included studies and consolidate the evidence on the safety and efficacy of short-term DAPT. METHODS Medline, Cochrane Library and Embase were searched from inception until August 2022. The primary outcome was the methodological quality of published primary studies. Risk of bias was assessed using RoB 2.0 and the CASP tool. Evidence was rated for quality using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) score approach. Other endpoints were all-cause mortality and major bleeding. RESULTS Eighteen RCTs were included. Based on GRADE score, there was a moderate level of certainty that the reported results for both outcomes are probably close to the true effect. A total of 78% (14/18) of RCTs had a low risk of bias when assessing all-cause mortality and 61% (11/18) when assessing major bleeding. The CASP tool confirmed methodological rigour; however, only 33% (6/18) of studies were applicable beyond the studied populations. Compared with 12 months of DAPT, short-term DAPT was associated with a reduced risk of major bleeding [relative risk (RR): 0.69, 95% CI: 0.54-0.88, P = 0.003, I2 = 45%] and trended towards a reduced risk in all-cause mortality (RR: 0.90, 95% CI: 0.79-1.01, P = 0.08, I2 = 0%). CONCLUSION With moderate certainty evidence, short-term DAPT appears safe and efficacious post-PCI with DES in the studied populations.
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Affiliation(s)
- Kolten Abbott
- Department of Medicine, Cairns and Hinterland Hospital and Health, Cairns North
- Department of Medicine, Griffith University School of Medicine
| | - Nicholas Seton
- Department of Medicine, Griffith University School of Medicine
- Department of Cardiology, Gold Coast Health Service, Southport
| | - Gurjeevan Kaur
- Department of Cardiology, Gold Coast Health Service, Southport
| | - Jilai Zhao
- Department of Medicine, Griffith University School of Medicine
| | - Mark Jones
- Department of Cardiology, Gold Coast Health Service, Southport
- Bond University Faculty of Health Sciences and Medicine, Gold Coast, Robina, Queensland
| | - Kuljit Singh
- Department of Medicine, Griffith University School of Medicine
- Department of Cardiology, Gold Coast Health Service, Southport
- Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia
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Xu L, Xu H, Wu S, Zhang H, Cheng K, Wang X, Chen M, Li G, Huang J, Lan J, Wei G, Zhao X, Qi Z, Qian J, Wu H, Ge J. Indobufen-based dual antiplatelet therapy in patients with multivessel coronary disease undergoing drug-eluting stent implantation insight from the OPTION trial. Am Heart J 2025; 282:21-29. [PMID: 39710353 DOI: 10.1016/j.ahj.2024.12.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/11/2024] [Revised: 12/17/2024] [Accepted: 12/18/2024] [Indexed: 12/24/2024]
Abstract
BACKGROUND It remains unclear whether indobufen-based dual antiplatelet therapy (DAPT) preserves ischemic protection while limiting bleeding risk in patients with multivessel coronary disease (MVD). This study aimed to investigate the efficacy and safety of indobufen-based DAPT in patients with MVD. METHODS Patients in the OPTION trial were stratified based on the presence of MVD. We compared the ischemic and bleeding risks of indobufen-based DAPT (indobufen 100mg twice a day plus clopidogrel 75 mg/d for 12 months) vs conventional DAPT (aspirin 100 mg/d plus clopidogrel 75 mg/d for 12 months) in patients with and without MVD, using landmarks at 6 months and 1-year post-percutaneous coronary intervention (PCI). RESULTS Patients with MVD tended to be older and contained a higher prevalence of high-risk features. Compared with patients without MVD, those with MVD were at higher risk for net adverse clinical events and ischemic events. The risk of ischemic events between indobufen-based DAPT vs conventional DAPT was similar either in patients with MVD or without MVD during the first and second 6 months. During the first 6 months, indobufen-based DAPT decreased the risk of bleeding events consistently in patients with and without MVD. Of note, during the second 6 months, indobufen-based DAPT continually decreased the risk of bleeding events in patients with MVD but not in those without MVD. CONCLUSIONS In patients with MVD, indobufen plus clopidogrel DAPT compared to aspirin plus clopidogrel DAPT could reduce the risk of bleeding events while preserving ischemic protection during both the first and second 6 months post-PCI. Indobufen presents an effective option for patients with MVD, especially those at high ischemic risk requiring DAPT beyond 6 months post-PCI. TRIAL REGISTRATION The trial was registered at www.chictr.org. A Randomized Controlled Trial of Indobufen vs Aspirin after Coronary Drug-eluting Stent Implantation: the OPTION Trial (ChiCTR-IIR-17013505).
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Affiliation(s)
- Lili Xu
- Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Fudan University, Shanghai, China; Department of Cardiology, Shanghai Geriatric Medical Center, Shanghai, China
| | - Huajie Xu
- Department of Infectious Diseases, Zhongshan Hospital, Fudan University, Shanghai, China
| | - Shujing Wu
- Department of Cardiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, China
| | - Huanyi Zhang
- Department of Cardiology, Taian City Central Hospital, Taian, Shandong, China
| | - Kang Cheng
- Department of Cardiology, Xi'an No.3 Hospital, The Affiliated Hospital of Northwest University, Xi'an, Shanxi, China
| | - Xiaoyan Wang
- Department of Cardiology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
| | - Manhua Chen
- Department of Cardiology, The Central Hospital of Wuhan, Wuhan, Hubei, China
| | - Guangping Li
- Department of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China
| | - Jiangnan Huang
- Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
| | - Jun Lan
- Department of Cardiology, Dongguan Third People's Hospital, Dongguan, Guangdong, China
| | - Guanghe Wei
- Department of Cardiology, Affiliated Hospital of Jining Medical University, Jining, Shandong, China
| | - Xin Zhao
- Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Fudan University, Shanghai, China
| | - Zhiyong Qi
- Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Fudan University, Shanghai, China
| | - Juying Qian
- Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Fudan University, Shanghai, China.
| | - Hongyi Wu
- Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Fudan University, Shanghai, China.
| | - Junbo Ge
- Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Fudan University, Shanghai, China; Department of Cardiology, Shanghai Geriatric Medical Center, Shanghai, China.
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Ingraham BS, Valgimigli M, Angiolillo DJ, Capodanno D, Rao SV, Urban P, Singh M. Relevance of High Bleeding Risk and Postdischarge Bleeding in Patients Undergoing Percutaneous Coronary Intervention. Mayo Clin Proc 2025; 100:304-331. [PMID: 39909670 DOI: 10.1016/j.mayocp.2024.09.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/19/2024] [Revised: 08/28/2024] [Accepted: 09/09/2024] [Indexed: 02/07/2025]
Abstract
Bleeding avoidance strategies are critical in the modern era of percutaneous coronary intervention; however, most efforts are geared toward reducing access-related complications. Improvements in procedural techniques (radial access, improved procedural anticoagulation regimens, etc) and modifications in postdischarge pharmacotherapy (shortened dual antiplatelet therapy, genotype-guided P2Y12 inhibition, etc) that led to a decline in bleeding related to percutaneous procedures were largely offset by increases in complexity and performance of percutaneous coronary intervention in high-risk patients. Among patients presenting with acute coronary syndrome, aggressive antiplatelet regimens with potent P2Y12 inhibitors are typically prescribed for a longer duration, prioritizing reduction in ischemic events over bleeding risk. Because postdischarge bleeding connotes an adverse prognosis similar to an ischemic event, postprocedure freedom from adverse outcomes can be best tailored by individualizing and recognizing the patient's bleeding and ischemic risks. This review of the contemporary and historical literature (PubMed, EMBASE, Cochrane Library) summarizes the available data, provides strategies to navigate these complex decisions, and helps individualize antithrombotic therapy.
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Affiliation(s)
| | - Marco Valgimigli
- Cardiocentro Ticino Institute and Università della Svizzera italiana, Lugano, Switzerland
| | | | - Davide Capodanno
- Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico-San Marco," University of Catania, Catania, Italy
| | - Sunil V Rao
- Division of Cardiology, NYU Langone Health and NYU Grossman School of Medicine, New York, NY
| | | | - Mandeep Singh
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.
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Scorpiglione L, Pizzicannella J, Bacigalupi E, Cicchitti V, Pelliccia F, Foglietta M, Gallina S, Zimarino M. Therapeutic strategies aiming at the reduction of the antiplatelet intensity should not overlook the ischemic risk in patients with coronary syndromes. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2025; 70:78-84. [PMID: 38987047 DOI: 10.1016/j.carrev.2024.06.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2024] [Revised: 05/22/2024] [Accepted: 06/17/2024] [Indexed: 07/12/2024]
Abstract
De-escalation of dual antiplatelet therapy (DAPT) is gaining traction as a strategy to reduce bleeding risks while ensuring ischemic outcomes. Undiscriminating de-escalation, notably in patients with high ischemic risk, might expose them to major adverse cardiac events. Platelet function and genetic tests are emerging tools to guide de-escalation, but both present specific drawbacks. Recent meta-analyses have aimed to consolidate the findings of individual trials to provide clearer insights. Yet, limitations remain for patients with concomitant high bleeding and ischemic risks. These high-risk patients are frequently underrepresented in clinical trials, and, therefore, currently available guidelines lack evidence-based recommendations for this subset. While DAPT de-escalation strategies hold promise, the choice of approach, whether clinically or assay-guided, remains complex and should be individualized.
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Affiliation(s)
- Luca Scorpiglione
- Department of Neuroscience, Imaging and Clinical Sciences, "G. d'Annunzio" University, Chieti-Pescara, Italy
| | - Jacopo Pizzicannella
- Department of Engineering and Geology, "G. d'Annunzio" University, Chieti-Pescara, Italy; Department of Cardiology, "SS.Annunziata Hospital", ASL 2 Abruzzo, Chieti, Italy.
| | - Elena Bacigalupi
- Department of Neuroscience, Imaging and Clinical Sciences, "G. d'Annunzio" University, Chieti-Pescara, Italy
| | - Vincenzo Cicchitti
- Department of Cardiology, "SS.Annunziata Hospital", ASL 2 Abruzzo, Chieti, Italy
| | | | - Melissa Foglietta
- Department of Cardiology, "SS.Annunziata Hospital", ASL 2 Abruzzo, Chieti, Italy
| | - Sabina Gallina
- Department of Neuroscience, Imaging and Clinical Sciences, "G. d'Annunzio" University, Chieti-Pescara, Italy
| | - Marco Zimarino
- Department of Neuroscience, Imaging and Clinical Sciences, "G. d'Annunzio" University, Chieti-Pescara, Italy; Department of Cardiology, "SS.Annunziata Hospital", ASL 2 Abruzzo, Chieti, Italy
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Watanabe H, Natsuaki M, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Ando K, Domei T, Suwa S, Ogita M, Isawa T, Takenaka H, Yamamoto T, Ishikawa T, Hisauchi I, Wakabayashi K, Onishi Y, Hibi K, Kawai K, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Ono K, Kimura T. Aspirin vs. clopidogrel monotherapy after percutaneous coronary intervention: 1-year follow-up of the STOPDAPT-3 trial. Eur Heart J 2024; 45:5042-5054. [PMID: 39215959 DOI: 10.1093/eurheartj/ehae617] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Revised: 08/17/2024] [Accepted: 08/25/2024] [Indexed: 09/04/2024] Open
Abstract
BACKGROUND AND AIMS There was no previous trial comparing aspirin monotherapy with a P2Y12 inhibitor monotherapy following short dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stents. METHODS In the STOPDAPT-3, patients with acute coronary syndrome or high bleeding risk (HBR) were randomly assigned to either 1-month dual antiplatelet therapy with aspirin and prasugrel followed by aspirin monotherapy (aspirin group) or 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This secondary analysis compared aspirin monotherapy with clopidogrel monotherapy by the 30-day landmark analysis. The co-primary endpoints were the cardiovascular endpoint defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke and the bleeding endpoint defined as Bleeding Academic Research Consortium 3 or 5. RESULTS Of the 6002 assigned patients, 5833 patients (aspirin group: N = 2920 and clopidogrel group: N = 2913) were included in the 30-day landmark analysis. Median age was 73 (interquartile range 64-80) years, women 23.4%, acute coronary syndrome 74.6%, and high bleeding risk 54.1%. The assigned monotherapy was continued at 1 year in 87.5% and 87.2% in the aspirin and clopidogrel groups, respectively. The incidence rates beyond 30 days and up to 1 year were similar between the aspirin and clopidogrel groups for both cardiovascular endpoint [4.5 and 4.5 per 100 person-year, hazard ratio 1.00 (95% confidence interval .77-1.30), P = .97], and bleeding endpoint [2.0 and 1.9, hazard ratio 1.02 (95% confidence interval .69-1.52), P = .92]. CONCLUSIONS Aspirin monotherapy compared with clopidogrel monotherapy was associated with similar cardiovascular and bleeding outcomes beyond 1 month and up to 1 year after percutaneous coronary intervention with drug-eluting stents (STOPDAPT-3 ClinicalTrials.gov number, NCT04609111).
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Affiliation(s)
- Hirotoshi Watanabe
- Division of Cardiology, Hirakata Kohsai Hospital, 1-2-1, Fujisaka-higashi-machi, Hirakata, Osaka 573-0153, Japan
| | | | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, Japan
| | - Ko Yamamoto
- Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
| | - Yuki Obayashi
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Ryusuke Nishikawa
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Tomoya Kimura
- Department of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, Japan
- Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan
| | - Kenji Ando
- Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
| | - Takenori Domei
- Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
| | - Satoru Suwa
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
| | - Manabu Ogita
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
| | - Tsuyoshi Isawa
- Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan
| | - Hiroyuki Takenaka
- Division of Cardiology, Hirakata Kohsai Hospital, 1-2-1, Fujisaka-higashi-machi, Hirakata, Osaka 573-0153, Japan
| | - Takashi Yamamoto
- Division of Cardiology, Hirakata Kohsai Hospital, 1-2-1, Fujisaka-higashi-machi, Hirakata, Osaka 573-0153, Japan
| | - Tetsuya Ishikawa
- Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan
| | - Itaru Hisauchi
- Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan
| | - Kohei Wakabayashi
- Department of Cardiology, Showa University Koto Toyosu Hospital, Tokyo, Japan
| | - Yuko Onishi
- Department of Cardiology, Hiratsuka Kyosai Hospital, Hiratsuka, Japan
| | - Kiyoshi Hibi
- Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
| | - Kazuya Kawai
- Division of Cardiology, Chikamori Hospital, Kochi, Japan
| | - Ruka Yoshida
- Division of Cardiology, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan
| | - Hiroshi Suzuki
- Division of Cardiology, Showa University Fujigaoka Hospital, Yokohama, Japan
| | - Gaku Nakazawa
- Department of Cardiology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | | | - Itsuro Morishima
- Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan
| | - Koh Ono
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Takeshi Kimura
- Division of Cardiology, Hirakata Kohsai Hospital, 1-2-1, Fujisaka-higashi-machi, Hirakata, Osaka 573-0153, Japan
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6
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Carvalho PEP, Gewehr DM, Nascimento BR, Melo L, Burkhardt G, Rivera A, Braga MAP, Guimarães PO, Mehran R, Windecker S, Valgimigli M, Angiolillo DJ, Bhatt DL, Sandoval Y, Chen SL, Stone GW, Lopes RD. Short-Term Dual Antiplatelet Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndromes: A Systematic Review and Network Meta-Analysis. JAMA Cardiol 2024; 9:1094-1105. [PMID: 39382876 PMCID: PMC11581547 DOI: 10.1001/jamacardio.2024.3216] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Accepted: 08/02/2024] [Indexed: 10/10/2024]
Abstract
Importance The optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) remains under debate. Objectives To analyze the efficacy and safety of DAPT strategies in patients with ACS using a bayesian network meta-analysis. Data Sources MEDLINE, Embase, Cochrane, and LILACS databases were searched from inception to April 8, 2024. Study Selection Randomized clinical trials (RCTs) comparing DAPT duration strategies in patients with ACS undergoing PCI were selected. Short-term strategies (1 month of DAPT followed by P2Y12 inhibitors, 3 months of DAPT followed by P2Y12 inhibitors, 3 months of DAPT followed by aspirin, and 6 months of DAPT followed by aspirin) were compared with conventional 12 months of DAPT. Data Extraction and Synthesis This systematic review and network meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The risk ratio (RR) with a 95% credible interval (CrI) was calculated within a bayesian random-effects network meta-analysis. Treatments were ranked using surface under the cumulative ranking (SUCRA). Main Outcomes and Measures The primary efficacy end point was major adverse cardiac and cerebrovascular events (MACCE); the primary safety end point was major bleeding. Results A total of 15 RCTs randomizing 35 326 patients (mean [SD] age, 63.1 [11.1] years; 26 954 male [76.3%]; 11 339 STEMI [32.1%]) with ACS were included. A total of 24 797 patients (70.2%) received potent P2Y12 inhibitors (ticagrelor or prasugrel). Compared with 12 months of DAPT, 1 month of DAPT followed by P2Y12 inhibitors reduced major bleeding (RR, 0.47; 95% CrI, 0.26-0.74) with no difference in MACCE (RR, 1.00; 95% CrI, 0.70-1.41). No significant differences were observed in MACCE incidence between strategies, although CrIs were wide. SUCRA ranked 1 month of DAPT followed by P2Y12 inhibitors as the best for reducing major bleeding and 3 months of DAPT followed by P2Y12 inhibitors as optimal for reducing MACCE (RR, 0.85; 95% CrI, 0.56-1.21). Conclusion and Relevance Results of this systematic review and network meta-analysis reveal that, in patients with ACS undergoing PCI with DES, 1 month of DAPT followed by potent P2Y12 inhibitor monotherapy was associated with a reduction in major bleeding without increasing MACCE when compared with 12 months of DAPT. However, an increased risk of MACCE cannot be excluded, and 3 months of DAPT followed by potent P2Y12 inhibitor monotherapy was ranked as the best option to reduce MACCE. Because most patients receiving P2Y12 inhibitor monotherapy were taking ticagrelor, the safety of stopping aspirin in those taking clopidogrel remains unclear.
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Affiliation(s)
- Pedro E. P. Carvalho
- Center for Coronary Artery Disease, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
| | - Douglas M. Gewehr
- Department of Internal Medicine, Federal University of Paraná, Curitiba, Brazil
| | - Bruno R. Nascimento
- Department of Internal Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil
- Interventional Cardiology Department, Hospital Madre Teresa, Belo Horizonte, Brazil
| | - Lara Melo
- Department of Internal Medicine, Connecticut University, Farmington
| | | | - André Rivera
- Department of Medicine, Nove de Julho University, São Bernardo do Campo, Brazil
| | - Marcelo A. P. Braga
- Department of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
| | | | - Roxana Mehran
- Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York
- Associate Editor, JAMA Cardiology
| | - Stephan Windecker
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Marco Valgimigli
- Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland
- The Department of Biomedical Sciences, University of Italian Switzerland, Lugano, Switzerland
- The University of Bern, Bern, Switzerland
| | | | - Deepak L. Bhatt
- Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Yader Sandoval
- Center for Coronary Artery Disease, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
| | - Shao-Liang Chen
- Nanjing Medical University and Nanjing First Hospital, Nanjing, China
| | - Gregg W. Stone
- Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Renato D. Lopes
- Division of Cardiology, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
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7
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Hong D, Lee SH, Heo J, Shin D, Cho J, Guallar E, Joh HS, Kim HK, Ha J, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Kang D, Lee JM. Safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis and deferred revascularization. REVISTA ESPANOLA DE CARDIOLOGIA (ENGLISH ED.) 2024:S1885-5857(24)00331-1. [PMID: 39542207 DOI: 10.1016/j.rec.2024.11.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/23/2024] [Accepted: 11/04/2024] [Indexed: 11/17/2024]
Abstract
INTRODUCTION AND OBJECTIVES This study investigated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis who underwent deferred revascularization due to their fractional flow reserve (FFR). METHODS A nationwide cohort study was conducted using the Korean National Health Insurance Service database. A total of 4657 patients with intermediate coronary artery stenosis who underwent deferred revascularization due to their FFR were identified from 2013 to 2020. FFR was indicated in patients with no prior evidence of myocardial ischemia and intermediate coronary artery stenosis (50%-70%) as determined by quantitative coronary angiography. Patients were classified according to whether antiplatelet therapy was initiated after the index procedure. The primary efficacy outcome was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke, during a 5-year follow-up period. The primary safety outcome was any gastrointestinal bleeding. RESULTS After propensity score matching, there were 1634 patients in the antiplatelet therapy group and 1634 in the nonantiplatelet therapy group. The risk of MACCE was similar between the 2 groups (24.8% vs 24.7%; adjusted HR, 0.97; 95%CI, 0.84-1.13; P=0.745). The risk of gastrointestinal bleeding was higher in the antiplatelet therapy group than in the nonantiplatelet therapy group (2.2% vs 1.2%; aHR, 2.07; 95%CI, 1.08-4.00). These results were similar in subgroup analyses. CONCLUSIONS In patients with intermediate coronary artery stenosis who underwent deferred revascularization due to their FFR, antiplatelet therapy may increase the risk of gastrointestinal bleeding without reducing the risk of future ischemic events.
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Affiliation(s)
- David Hong
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Seung Hun Lee
- Division of Cardiology, Department of Internal Medicine, Heart Center, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea
| | - Jihye Heo
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea; Department of Clinical Research Design and Evaluation, Samsung Advances Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, South Korea
| | - Doosup Shin
- Department of Cardiology, St Francis Hospital and Heart Center, Roslyn, New York, United States
| | - Juhee Cho
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea; Department of Clinical Research Design and Evaluation, Samsung Advances Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, South Korea
| | - Eliseo Guallar
- Department of Epidemiology and Medicine, and Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States
| | - Hyun Sung Joh
- Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea
| | - Hyun Kuk Kim
- Department of Internal Medicine and Cardiovascular Center, Chosun University Hospital, University of Chosun College of Medicine, Gwangju, Republic of Korea
| | - Junho Ha
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Ki Hong Choi
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Taek Kyu Park
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Jeong Hoon Yang
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Young Bin Song
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Joo-Yong Hahn
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Seung-Hyuk Choi
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Hyeon-Cheol Gwon
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Danbee Kang
- Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea; Department of Clinical Research Design and Evaluation, Samsung Advances Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, South Korea.
| | - Joo Myung Lee
- Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
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Ullah W, Sandhyavenu H, Taha A, Narayana Gowda S, Mukhtar M, Reddy Polam A, Zahid S, Fischman DL, Savage MP, Rao SV, Alkhouli M. Antiplatelet Strategy for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis. J Am Heart Assoc 2024; 13:e032490. [PMID: 39392170 PMCID: PMC11935570 DOI: 10.1161/jaha.122.032490] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/09/2023] [Accepted: 07/10/2024] [Indexed: 10/12/2024]
Abstract
BACKGROUND Optimal duration and choice of antiplatelet therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention remain controversial. METHODS AND RESULTS Digital databases (PubMed, Cochrane, and Embase) were queried to select all randomized controlled trials on a post-percutaneous coronary intervention population with acute coronary syndrome. Dual-antiplatelet therapy (DAPT) with aspirin and clopidogrel for 12 months was compared with 4 major strategies: high-potency, high- to low-potency, low-dose, and short-duration DAPT. A network meta-analysis was performed to compare the safety and efficacy of different antiplatelet strategies. This study was the second updated manuscript under the International Prospective Register of Systematic Review registration (CRD42021286552). Thirty-two randomized controlled trials comprising 103 459 (51 750 experimental, 51 709 control) patients were included. Compared with DAPT with aspirin and clopidogrel for 12 months, high- to low-potency DAPT (risk ratio [RR], 0.69 [95% CI, 0.52-0.92]) and aspirin+prasugrel containing DAPT for 12 months (RR, 0.84 [95% CI, 0.72-0.98]) had a significantly lower, whereas DAPT for 1 month followed by clopidogrel only (RR, 1.59 [95% CI, 1.06-2.39]) had a higher, incidence of major adverse cardiovascular events at 1 year (median follow-up). Prasugrel (RR, 1.35 [95% CI, 1.09-1.66]) and ticagrelor (RR, 1.38 [95% CI, 1.17-1.62]) containing DAPT for 12 months had significantly higher rates, whereas high- to low-potency DAPT (RR, 0.85 [95% CI, 0.63-1.15]) had no significant risk of major bleeding. CONCLUSIONS Aspirin and ticagrelor for 3 months, followed by aspirin and clopidogrel for the remaining duration, can be considered the optimal strategy for treating post-percutaneous coronary intervention patients with acute coronary syndrome because of a significantly reduced risk of major adverse cardiovascular events without increasing the risk of bleeding.
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Affiliation(s)
- Waqas Ullah
- Thomas Jefferson University HospitalsPhiladelphiaPA
| | | | | | | | - Maryam Mukhtar
- University Hospitals of Leicester National Health Service TrustLeicesterUK
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Mazzone PM, Spagnolo M, Capodanno D. Antithrombotic Therapy in Patients with Chronic Coronary Syndromes. Interv Cardiol Clin 2024; 13:493-505. [PMID: 39245549 DOI: 10.1016/j.iccl.2024.06.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/10/2024]
Abstract
The antithrombotic management of chronic coronary syndrome (CCS) involves a 6-month course of dual antiplatelet therapy (DAPT), followed by chronic aspirin therapy. In patients with a baseline indication for anticoagulation, a variable duration of triple antithrombotic therapy is administered, followed by dual antithrombotic therapy until the sixth month post-percutaneous coronary intervention (PCI), and ultimately a transition to chronic anticoagulation. However, advancements in stent technology reducing the risk of stent thrombosis and a growing focus on the impact of bleeding on prognosis have prompted the development of new therapeutic strategies. These strategies aim to enhance protection against ischemic events in the initial stages after PCI while mitigating the risk of bleeding in the long term. This article delineates the therapeutic strategies outlined in European and American guidelines for CCS management, with special attention to investigational strategies.
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Affiliation(s)
- Placido Maria Mazzone
- Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco" University of Catania, Via Santa Sofia, 78, Catania 95123, Italy
| | - Marco Spagnolo
- Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco" University of Catania, Via Santa Sofia, 78, Catania 95123, Italy
| | - Davide Capodanno
- Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco" University of Catania, Via Santa Sofia, 78, Catania 95123, Italy.
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10
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Öz A, Toprak K, Aydin E, Saraç İ, Doğduş M, Opan S, Yenerçağ M, Tascanov MB, Kümet Ö, Karaağaç M, Özmen M, Murat B, Kertmen Ö, Bekler Ö, İnci S, Huyut MA, Özderya A, Er F, Duran M, Ardahanlı İ, Baş MM, Güzel T, Ceyhun G, Özdemir İH, Özen MB, Gündüz R, Erdoğan A, Çetin İ, Barış VÖ, Yayla Ç, Karaduman M, Aşkın L, Bekar L, Tanrıverdi O, Özkan E, Yeşil E, Çalışkan S, Kuzu Z, Uğuz B, Böyük F, Kunak AÜ, Murat S, Asil S, Kayhan Ö, Erdoğan E, Duz R, Katkat F, Ekin T, İbişoğlu E, Ateş BN, Ayça B, Ergene AO, Zoghi M. Fixed-Dose Antiplatelet Dual Combination in Patients with Coronary Artery Disease in Turkish Population: DAPT-TR. Arq Bras Cardiol 2024; 121:e20240202. [PMID: 39607170 PMCID: PMC11634293 DOI: 10.36660/abc.20240202] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2024] [Revised: 06/04/2024] [Accepted: 07/31/2024] [Indexed: 11/29/2024] Open
Abstract
BACKGROUND Dual antiplatelet therapy (DAPT) is the treatment of choice for patients with acute and chronic coronary syndromes as it reduces mortality and prevents recurrent thrombotic complications. The assessment of both ischaemic burden and bleeding risk is crucial in deciding which DAPT to choose and how long it should be continued. OBJECTIVES The aim of our study was to perform prospective clinical follow-up of patients receiving fixed-dose combination therapy (ASA 75 mg + clopidogrel 75 mg). Our study is a multicentric, cross-sectional, observational, cohort study. METHODS A total of 1500 patients who were started on fixed-dose combination DAPT for acute or chronic coronary syndrome were included in the study. Primary endpoints were hospitalization for any reason, hospitalization for cardiovascular cause, acute myocardial infarction, stent thrombosis, target vessel revascularization and bleeding; the secondary endpoints were death for any reason or cardiovascular cause and stroke. The significance level adopted in the statistical analysis was 5%. RESULTS Median age was 63 years; 78.5% of the patients were receiving DAPT treatment for acute coronary syndrome. The rates of hospitalization for cardiovascular reasons, acute myocardial infartion, stent thrombosis and target-vessel revascularization were 7.9%, 2.3%, 1.3% and 4.2%, respectively. While the rate of BARC type 1 bleeding was 3.3%, the rate of BARC type 5, 3, or 2 bleeding was 0.6%. The secondary endpoints which were death from any cause, cardiovascular death and stroke were 0.5%, 0.3% and 0.3%, respectively. Conclusion: Our study shows that fixed-dose combination therapy is effective and safe in appropriately selected patients with acute or chronic coronary syndromes.
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Affiliation(s)
- Ahmet Öz
- Department of CardiologyHealth Science University Istanbul Training and Research HospitalIstanbulTurquiaDepartment of Cardiology, Health Science University, Istanbul Training and Research Hospital, Istanbul - Turquia
| | - Kenan Toprak
- Harran UniversityFaculty of MedicineDepartment of CardiologySanliurfaTurquiaHarran University, Faculty of Medicine, Department of Cardiology, Sanliurfa - Turquia
| | - Ertan Aydin
- Giresun Training and Research HospitalDepartment of CardiologyGiresunTurquiaGiresun Training and Research Hospital, Department of Cardiology, Giresun - Turquia
| | - İbrahim Saraç
- Erzurum City HospitalDepartment of CardiologyErzurumTurkeyErzurum City Hospital, Department of Cardiology, Erzurum - Turkey
| | - Mustafa Doğduş
- Uşak UniversityTraining and Research HospitalDepartment of CardiologyUsakTurquiaUşak University Training and Research Hospital, Department of Cardiology, Usak - Turquia
| | - Selçuk Opan
- Sanliurfa Training and Research HospitalDepartment of CardiologyŞanlıurfaTurquiaSanliurfa Training and Research Hospital, Department of Cardiology, Şanlıurfa - Turquia
| | - Mustafa Yenerçağ
- Samsun UniversityFaculty of MedicineDepartment of CardiologySamsunTurquiaSamsun University, Faculty of Medicine, Department of Cardiology, Samsun - Turquia
| | - Mustafa Begenc Tascanov
- Harran UniversityFaculty of MedicineDepartment of CardiologySanliurfaTurquiaHarran University, Faculty of Medicine, Department of Cardiology, Sanliurfa - Turquia
| | - Ömer Kümet
- Van Training and Research HospitalDepartment of CardiologyVanTurquiaVan Training and Research Hospital, Department of Cardiology, Van - Turquia
| | - Miraç Karaağaç
- İnönü University Turgut Özal Tıp MerkeziTraining and Research HospitalDepartment of CardiologyMalatyaTurquiaİnönü University Turgut Özal Tıp Merkezi Training and Research Hospital, Department of Cardiology, Malatya - Turquia
| | - Murat Özmen
- Erzurum City HospitalDepartment of CardiologyErzurumTurkeyErzurum City Hospital, Department of Cardiology, Erzurum - Turkey
| | - Bektaş Murat
- Eskişehir City HospitalDepartment of CardiologyEskişehirTurquiaEskişehir City Hospital, Department of Cardiology, Eskişehir - Turquia
| | - Ömer Kertmen
- Amasya University Sabuncuoğlu ŞerefeddinTraining and Research HospitalDepartment of CardiologyAmasyaTurquia Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital, Department of Cardiology, Amasya - Turquia
| | - Özkan Bekler
- Mustafa Kemal UniversityFaculty of MedicineDepartment of CardiologyHatayTurquiaMustafa Kemal University, Faculty of Medicine, Department of Cardiology, Hatay - Turquia
| | - Sinan İnci
- Aksaray UniversityFaculty of MedicineDepartment of CardiologyAksarayTurquiaAksaray University, Faculty of Medicine, Department of Cardiology, Aksaray - Turquia
| | - Mustafa Ahmet Huyut
- İstanbul Prof.Dr.Cemil Taşcıoğlu City HospitalDepartment of CardiologyİstanbulTurquiaİstanbul Prof.Dr.Cemil Taşcıoğlu City Hospital, Department of Cardiology, İstanbul - Turquia
| | - Ahmet Özderya
- Trabzon Kanuni Training and Research HospitalDepartment of Cardiology,TrabzonTurquiaTrabzon Kanuni Training and Research Hospital, Department of Cardiology, Trabzon - Turquia
| | - Fahri Er
- Ağrı Training and Research HospitalDepartment of Cardiology,AğrıTurquiaAğrı Training and Research Hospital, Department of Cardiology, Ağrı - Turquia
| | - Mustafa Duran
- Konya City HospitalDepartment of CardiologyKonyaTurquiaKonya City Hospital, Department of Cardiology, Konya - Turquia
| | - İsa Ardahanlı
- Bilcecik Şeyh Edebali UniversityFaculty of MedicineDepartment of CardiologyBilecikTurquiaBilcecik Şeyh Edebali University, Faculty of Medicine, Department of Cardiology, Bilecik - Turquia
| | - Mehmet Memduh Baş
- Private Meydan HospitalDepartment of CardiologyŞanlıurfaTurquiaPrivate Meydan Hospital, Department of Cardiology, Şanlıurfa - Turquia
| | - Tuncay Güzel
- Gazi Yaşargil Training and Research HospitalDepartment of CardiologyDiyarbakırTurquiaGazi Yaşargil Training and Research Hospital, Department of Cardiology, Diyarbakır - Turquia
| | - Gökhan Ceyhun
- Atatürk UniversityFaculty of MedicineDepartment of CardiologyErzurumTurquiaAtatürk University, Faculty of Medicine, Department of Cardiology, Erzurum - Turquia
| | - İbrahim Halil Özdemir
- Manisa City HospitalDepartment of CardiologyManisaTurquiaManisa City Hospital, Department of Cardiology, Manisa - Turquia
| | - Mehmet Burak Özen
- Manisa City HospitalDepartment of CardiologyManisaTurquiaManisa City Hospital, Department of Cardiology, Manisa - Turquia
| | - Ramazan Gündüz
- Manisa City HospitalDepartment of CardiologyManisaTurquiaManisa City Hospital, Department of Cardiology, Manisa - Turquia
| | - Aslan Erdoğan
- Başakşehir Çam ve Sakura City HospitalDepartment of CardiologyİstanbulTurquiaBaşakşehir Çam ve Sakura City Hospital, Department of Cardiology, İstanbul - Turquia
| | - İlyas Çetin
- Başakşehir Çam ve Sakura City HospitalDepartment of CardiologyİstanbulTurquiaBaşakşehir Çam ve Sakura City Hospital, Department of Cardiology, İstanbul - Turquia
| | - Veysel Özgür Barış
- Gaziantep Dr. Ersin Arslan Training and Research HospitalDepartment of CardiologyGaziantepTurquiaGaziantep Dr. Ersin Arslan Training and Research Hospital, Department of Cardiology, Gaziantep - Turquia
| | - Çağrı Yayla
- Ankara Bilkent City HospitalDepartment of CardiologyAnkaraTurquiaAnkara Bilkent City Hospital, Department of Cardiology,Ankara – Turquia
| | - Medeni Karaduman
- Van Yüzüncü Yıl UniversityFaculty of MedicineDepartment of CardiologyVanTurquiaVan Yüzüncü Yıl University, Faculty of Medicine, Department of Cardiology, Van - Turquia
| | - Lütfü Aşkın
- Gaziantep İslam Bilim ve Teknoloji UniversityFaculty of MedicineDepartment of CardiologyGaziantepTurquiaGaziantep İslam Bilim ve Teknoloji University, Faculty of Medicine, Department of Cardiology, Gaziantep - Turquia
| | - Lütfü Bekar
- Hitit UniversityFaculty of MedicineDepartment of CardiologyÇorumTurquiaHitit University, Faculty of Medicine, Department of Cardiology, Çorum - Turquia
| | - Okan Tanrıverdi
- Adıyaman UniversityFaculty of MedicineDepartment of CardiologyAdıyamanTurquiaAdıyaman University, Faculty of Medicine, Department of Cardiology, Adıyaman – Turquia
| | - Eyüp Özkan
- Başakşehir Çam ve Sakura City HospitalDepartment of CardiologyİstanbulTurquiaBaşakşehir Çam ve Sakura City Hospital, Department of Cardiology, İstanbul - Turquia
| | - Emrah Yeşil
- Mersin UniversityFaculty of MedicineDepartment of CardiologyMersinTurquia Mersin University, Faculty of Medicine, Department of Cardiology, Mersin - Turquia
| | - Serhat Çalışkan
- Bahçelievler State HospitalDepartment of CardiologyİstanbulTurquia Bahçelievler State Hospital, Department of Cardiology,İstanbul - Turquia
| | - Zülfiye Kuzu
- Kayseri City HospitalDepartment of CardiologyKayseriTurquiaKayseri City Hospital, Department of Cardiology, Kayseri - Turquia
| | - Berat Uğuz
- Bursa City HospitalDepartment of CardiologyBursaTurquiaBursa City Hospital, Department of Cardiology, Bursa - Turquia
| | - Ferit Böyük
- Yedikule Chest Diseases and Thoracic Surgery Training and Research HospitalDepartment of CardiologyİstanbulTurquiaYedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Department of Cardiology, İstanbul - Turquia
| | - Ayşegül Ülgen Kunak
- Bandırma Training and Research HospitalDepartment of CardiologyBalıkesirTurquiaBandırma Training and Research Hospital, Department of Cardiology, Balıkesir - Turquia
| | - Selda Murat
- Eskişehir Osmangazi UniversityFaculty of MedicineDepartment of CardiologyEskişehirTurquiaEskişehir Osmangazi University, Faculty of Medicine, Department of Cardiology, Eskişehir - Turquia
| | - Serkan Asil
- Gülhane Training and Research HospitalDepartment of CardiologyAnkaraTurquiaGülhane Training and Research Hospital, Department of Cardiology, Ankara - Turquia
| | - Özkan Kayhan
- Kepez State HospitalDepartment of CardiologyAntalyaTurquiaKepez State Hospital, Department of Cardiology, Antalya - Turquia
| | - Emrah Erdoğan
- Van Yüzüncü Yıl UniversityFaculty of MedicineDepartment of CardiologyVanTurquiaVan Yüzüncü Yıl University, Faculty of Medicine, Department of Cardiology, Van - Turquia
| | - Ramazan Duz
- Van Yüzüncü Yıl UniversityFaculty of MedicineDepartment of CardiologyVanTurquiaVan Yüzüncü Yıl University, Faculty of Medicine, Department of Cardiology, Van - Turquia
| | - Fahrettin Katkat
- İstanbul Training and Research HospitalDepartment of CardiologyİstanbulTurquiaİstanbul Training and Research Hospital, Department of Cardiology, İstanbul - Turquia
| | - Tuba Ekin
- Kırşehir Ahi Evran UniversityTraining and Research HospitalDepartment of CardiologyKırşehirTurquiaKırşehir Ahi Evran University Training and Research Hospital, Department of Cardiology, Kırşehir - Turquia
| | - Ersin İbişoğlu
- Başakşehir Çam ve Sakura City HospitalDepartment of CardiologyİstanbulTurquiaBaşakşehir Çam ve Sakura City Hospital, Department of Cardiology, İstanbul - Turquia
| | - Bilge Nazar Ateş
- Ankara UniversityFaculty of MedicineDepartment of CardiologyAnkaraTurquiaAnkara University, Faculty of Medicine, Department of Cardiology, Ankara - Turquia
| | - Burak Ayça
- İstanbul Training and Research HospitalDepartment of CardiologyİstanbulTurquiaİstanbul Training and Research Hospital, Department of Cardiology, İstanbul - Turquia
| | - Asım Oktay Ergene
- Dokuz Eylul UniversityDepartment of CardiologyIzmirTurquiaDokuz Eylul University, Department of Cardiology, Izmir - Turquia
| | - Mehdi Zoghi
- Ege UniversityDepartment of CardiologyIzmirTurquiaEge University, Department of Cardiology, Izmir - Turquia
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11
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Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J 2024; 45:3415-3537. [PMID: 39210710 DOI: 10.1093/eurheartj/ehae177] [Citation(s) in RCA: 120] [Impact Index Per Article: 120.0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/04/2024] Open
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12
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Park DY, Hu JR, Campbell G, Goldwag K, Kelsey MD, Altin SE, Gallegos-Kattán C, Nanna MG. Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2024; 3:101859. [PMID: 39131993 PMCID: PMC11307649 DOI: 10.1016/j.jscai.2024.101859] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/21/2023] [Revised: 02/06/2024] [Accepted: 02/20/2024] [Indexed: 08/13/2024]
Abstract
Background Patients with type 2 diabetes mellitus (DM) comprise more than a quarter of all patients undergoing percutaneous coronary intervention and are at higher risk of adverse events. We sought to reexamine the optimal duration of dual antiplatelet therapy (DAPT) postpercutaneous coronary intervention in patients with DM. Methods We systematically included randomized controlled trials comparing any 2 of 1, 3, 6, and 12 months of DAPT that reported major adverse cardiovascular events (MACE), net adverse clinical events (NACE), bleeding, or stent thrombosis in DM, and performed a frequentist network meta-analysis. We also performed a sensitivity analysis of trials that exclusively enrolled patients with acute coronary syndrome. Results In 16 randomized controlled trials comprising 16,376 adults with DM, there was no significant difference in NACE, MACE, stent thrombosis, or major bleeding between pairwise comparisons of 1, 3, 6, and 12 months of DAPT, except for a signal for lower bleeding with 3 months of DAPT compared to 12 (risk ratio, 0.72; 95% CI, 0.51-0.99). Sensitivity analysis of trials that solely included acute coronary syndrome similarly showed no significant difference in MACE between 1, 3, 6, and 12 months of DAPT. Conclusions Our study found no meaningful difference in NACE or MACE between pairwise comparisons of 1, 3, 6, and 12 months of DAPT by study-level meta-analysis of patients with DM, with lower bleeding risk observed with 3 months than with 12 months of DAPT. This finding may provide clinicians greater flexibility to personalize patients' DAPT duration based on other non-DM comorbidities that might affect bleeding or thrombosis risk.
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Affiliation(s)
- Dae Yong Park
- Department of Medicine, Cook County Health, Chicago, Illinois
| | - Jiun-Ruey Hu
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Greta Campbell
- Department of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
| | - Kiara Goldwag
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Michelle D. Kelsey
- Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina
| | - S. Elissa Altin
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
| | | | - Michael G. Nanna
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
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13
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Xiong P, Zheng C, Fan J, Zhang H, Li C. Short-term (1-3 months) versus standard (12 months) dual antiplatelet therapy following new-generation drug-eluting stent implantation: A meta-analysis of randomized controlled trials. Medicine (Baltimore) 2024; 103:e38071. [PMID: 39259115 PMCID: PMC11142824 DOI: 10.1097/md.0000000000038071] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/22/2023] [Revised: 02/22/2024] [Accepted: 04/10/2024] [Indexed: 09/12/2024] Open
Abstract
BACKGROUND Patients undergoing percutaneous coronary intervention mainly receive antiplatelet therapy. However, limited data are available regarding the optimal dual antiplatelet therapy (DAPT) following the implantation of new-generation drug-eluting stent (DES). OBJECTIVE This study aimed to compare the clinical outcomes of short-term (1-3 months) DAPT and standard (12 months) DAPT after the implantation of a new-generation of DES. METHODS We systematically searched PubMed, The Cochrane Library Database, Embase for trials that compared short-term (1-3 months) and standard DAPT after the implantation of next-generation DES were retrieved from all published studies in English until December 31, 2021. The primary endpoint was major bleeding. The secondary endpoints included all-cause mortality, cardiac death, myocardial infarction, stroke, stent thrombosis, and all bleeding. RESULTS This study included a total of 7 randomized controlled trials, comprising 28,344 subjects. Regarding primary endpoints, short-term DAPT exhibited a significantly lower incidence of major bleeding compared with standard DAPT [relative risk (RR): 0.66, 95% confidence interval (CI): (0.54, 0.81), P < .0001]. For secondary endpoints, there were significant differences between short-term and standard DAPT in all bleeding [RR: 0.59, 95% CI: (0.50, 0.69), P < .00001]. However, no significant differences were identified in all-cause mortality [RR: 0.96, 95% CI: (0.77, 1.18), P = .27], myocardial infarction [RR: 0.98, 95% CI: (0.82, 1.18), P = .86], cardiac death [RR: 0.83, 95% CI: (0.63, 1.10), P = .20], stroke [RR: 1.08, 95% CI: (0.79, 1.47), P = .63], cerebrovascular [RR: 1.08, 95% CI: (0.79, 1.47), P = .63], and stent thrombosis [RR: 1.13, 95% CI: (0.80, 1.57), P = .49] between the 2 groups. CONCLUSION In patients undergoing implantation of a new-generation of DES, short-term (1-3 months) DAPT exhibited no inferiority compared with standard (12 months) DAPT in terms of all-cause mortality, cardiac death, myocardial infarction, stroke, and definite or probable stent thrombosis compared with standard (12 months) DAPT. However, short-term DAPT appeared superior to standard DAPT in terms of major bleeding and all bleeding.
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Affiliation(s)
- Penghui Xiong
- Department of Cardiology, The First Hospital of Nanchang, Nanchang, Jiangxi, China
| | - Chunhua Zheng
- Department of Cardiology, The First Hospital of Nanchang, Nanchang, Jiangxi, China
| | - Jianfeng Fan
- Department of Cardiology, The First Hospital of Nanchang, Nanchang, Jiangxi, China
| | - Hongyu Zhang
- Department of Cardiology, The First Hospital of Nanchang, Nanchang, Jiangxi, China
| | - Can Li
- Department of Cardiology, The First Hospital of Nanchang, Nanchang, Jiangxi, China
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14
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De Filippo O, Piroli F, Bruno F, Bocchino PP, Saglietto A, Franchin L, Angelini F, Gallone G, Rizzello G, Ahmad M, Gasparini M, Chatterjee S, De Ferrari GM, D'Ascenzo F. De-escalation of dual antiplatelet therapy for patients with acute coronary syndrome after percutaneous coronary intervention: a systematic review and network meta-analysis. BMJ Evid Based Med 2024; 29:171-186. [PMID: 38242567 DOI: 10.1136/bmjebm-2023-112476] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 12/25/2023] [Indexed: 01/21/2024]
Abstract
OBJECTIVES To compare dual antiplatelet therapy (DAPT) de-escalation with five alternative DAPT strategies in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). DESIGN We conducted a systematic review and network meta-analysis (NMA). Parallel-arm randomised controlled trials (RCTs) comparing DAPT strategies were included and arms of interest were compared via NMA. Partial ranking of each identified arm and for each investigated endpoint was also performed. SETTING AND PARTICIPANTS Adult patients with ACS (≥18 years) undergoing PCI with indications for DAPT. SEARCH METHODS A comprehensive search covered several databases (PubMed, Embase, Cochrane Central, MEDLINE, Conference Proceeding Citation Index-Science) from inception to 15 October 2023. Medical subject headings and keywords related to ACS, PCI and DAPT interventions were used. Reference lists of included studies were screened. Clinical trials registers were searched for ongoing or unpublished trials. INTERVENTIONS Six strategies were assessed: T1 arm: acetylsalicylic acid (ASA) and prasugrel for 12 months; T2 arm: ASA and low-dose prasugrel for 12 months; T3 arm: ASA and ticagrelor for 12 months; T4 arm: DAPT de-escalation (ASA+P2Y12 inhibitor for 1-3 months, then single antiplatelet therapy with potent P2Y12 inhibitor or DAPT with clopidogrel); T5 arm: ASA and clopidogrel for 12 months; T6 arm: ASA and clopidogrel for 3-6 months. MAIN OUTCOME MEASURES Primary outcome: Cardiovascular mortality. SECONDARY OUTCOMES bleeding events (all, major, minor), stent thrombosis (ST), stroke, myocardial infarction (MI), all-cause mortality, major adverse cardiovascular events (MACE). RESULTS 23 RCTs (75 064 patients with ACS) were included. No differences in cardiovascular mortality, all-cause death, recurrent MI or MACE were found when the six strategies were compared, although with different levels of certainty of evidence. ASA and clopidogrel for 12 or 3-6 months may result in a large increase of ST risk versus ASA plus full-dose prasugrel (OR 2.00, 95% CI 1.14 to 3.12, and OR 3.42, 95% CI 1.33 to 7.26, respectively; low certainty evidence for both comparisons). DAPT de-escalation probably results in a reduced risk of all bleedings compared with ASA plus full-dose 12-month prasugrel (OR 0.49, 95% CI 0.26 to 0.81, moderate-certainty evidence) and ASA plus 12-month ticagrelor (OR 0.52, 95% CI 0.33 to 0.75), while it may not increase the risk of ST. ASA plus 12-month clopidogrel may reduce all bleedings versus ASA plus full-dose 12-month prasugrel (OR 0.66, 95% CI 0.42 to 0.94, low certainty) and ASA plus 12-month ticagrelor (OR 0.70, 95% CI 0.52 to 0.89). CONCLUSIONS DAPT de-escalation and ASA-clopidogrel regimens may reduce bleeding events compared with 12 months ASA and potent P2Y12 inhibitors. 3-6 months or 12-month aspirin-clopidogrel may increase ST risk compared with 12-month aspirin plus potent P2Y12 inhibitors, while DAPT de-escalation probably does not.
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Affiliation(s)
- Ovidio De Filippo
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Francesco Piroli
- S.O.C. Cardiologia Ospedaliera, Presidio Ospedaliero Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia - IRCCS, Reggio Emilia, Italy
| | - Francesco Bruno
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Pier Paolo Bocchino
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Andrea Saglietto
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Luca Franchin
- Cardiology Department, University Hospital 'Santa Maria della Misericordia', Azienda Sanitaria Universitaria Integrata Friuli Centrale (ASUFC), Udine, Italy
| | - Filippo Angelini
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Guglielmo Gallone
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Giulia Rizzello
- Dipartimento di Scienze Matematiche (DISMA), Giuseppe Luigi Lagrange, Politecnico di Torino, Torino, Italy
| | | | - Mauro Gasparini
- Dipartimento di Scienze Matematiche (DISMA), Giuseppe Luigi Lagrange, Politecnico di Torino, Torino, Italy
| | - Saurav Chatterjee
- New York Community Hospital, Maimonides Health, Brooklyn, New York, USA
- Zucker School of Medicine, Hempstead, New York, USA
| | - Gaetano Maria De Ferrari
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Fabrizio D'Ascenzo
- Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, Turin, Italy
- Department of Medical Sciences, University of Turin, Turin, Italy
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15
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Park DY, Hu JR, Jamil Y, Kelsey MD, Jones WS, Frampton J, Kochar A, Aronow WS, Damluji AA, Nanna MG. Shorter Dual Antiplatelet Therapy for Older Adults After Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis. JAMA Netw Open 2024; 7:e244000. [PMID: 38546647 PMCID: PMC10979312 DOI: 10.1001/jamanetworkopen.2024.4000] [Citation(s) in RCA: 3] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2023] [Accepted: 01/31/2024] [Indexed: 04/01/2024] Open
Abstract
IMPORTANCE The optimal duration of dual antiplatelet therapy (DAPT) for older adults after percutaneous coronary intervention (PCI) is uncertain because they are simultaneously at higher risk for both ischemic and bleeding events. OBJECTIVE To investigate the association of abbreviated DAPT with adverse clinical events among older adults after PCI. DATA SOURCES The Cochrane Library, Google Scholar, Embase, MEDLINE, PubMed, Scopus, and Web of Science were searched from inception to August 9, 2023. STUDY SELECTION Randomized clinical trials comparing any 2 of 1, 3, 6, and 12 months of DAPT were included if they reported results for adults aged 65 years or older or 75 years or older. DATA EXTRACTION AND SYNTHESIS The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline was used to abstract data and assess data quality. Risk ratios for each duration of DAPT were calculated with alternation of the reference group. MAIN OUTCOMES AND MEASURES The primary outcome of interest was net adverse clinical events (NACE). Secondary outcomes were major adverse cardiovascular events (MACE) and bleeding. RESULTS In 14 randomized clinical trials comprising 19 102 older adults, no differences were observed in the risks of NACE or MACE for 1, 3, 6, and 12 months of DAPT. However, 3 months of DAPT was associated with a lower risk of bleeding compared with 6 months of DAPT (relative risk [RR], 0.50 [95% CI, 0.29-0.84]) and 12 months of DAPT (RR, 0.57 [95% CI, 0.45-0.71]) among older adults. One month of DAPT was also associated with a lower risk of bleeding compared with 6 months of DAPT (RR, 0.68 [95% CI, 0.54-0.86]). CONCLUSIONS AND RELEVANCE In this systematic review and meta-analysis of different durations of DAPT for older adults after PCI, an abbreviated DAPT duration was associated with a lower risk of bleeding without any concomitant increase in the risk of MACE or NACE despite the concern for higher-risk coronary anatomy and comorbidities among older adults. This study, which represents the first network meta-analysis of this shortened treatment for older adults, suggests that clinicians may consider abbreviating DAPT for older adults.
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Affiliation(s)
- Dae Yong Park
- Department of Medicine, Cook County Health, Chicago, Illinois
| | - Jiun-Ruey Hu
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Yasser Jamil
- Department of Medicine, Yale-Waterbury Hospital, Waterbury, Connecticut
| | - Michelle D. Kelsey
- Division of Cardiology, Duke University Medical Center, Durham, North Carolina
- Duke Clinical Research Institute, Durham, North Carolina
| | - W. Schuyler Jones
- Division of Cardiology, Duke University Medical Center, Durham, North Carolina
- Duke Clinical Research Institute, Durham, North Carolina
| | - Jennifer Frampton
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Ajar Kochar
- Department of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
- Richard and Susan Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
| | - Wilbert S. Aronow
- Department of Cardiology, Westchester Medical Center, Valhalla, New York
| | - Abdulla A. Damluji
- Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland
- Inova Center of Outcomes Research, Inova Heart and Vascular Institute, Falls Church, Virginia
| | - Michael G. Nanna
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
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16
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Min PK, Kang TS, Cho YH, Cheong SS, Kim BK, Kwon SW, Park WJ, Lee JH, Kim W, Lee WS, Yoon YW, Lee BK, Kwon HM, Hong BK. P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial. JAMA Netw Open 2024; 7:e240877. [PMID: 38451525 PMCID: PMC10921250 DOI: 10.1001/jamanetworkopen.2024.0877] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2023] [Accepted: 01/12/2024] [Indexed: 03/08/2024] Open
Abstract
Importance P2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent. Objective To investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent. Design, Setting, and Participants The Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, through December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents were enrolled. Interventions Patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693). Main Outcomes and Measures The primary outcome was a net adverse clinical event, a composite of major bleeding (based on Bleeding Academic Research Consortium type 3 or type 5 bleeding) and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%. Results Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean [SD] age, 63.0 [10.7] years; 1055 men [76.1%]) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693). Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 9 patients (1.7%) in the P2Y12 inhibitor monotherapy group and in 16 patients (2.6%) in the DAPT group (absolute difference, -0.93 [1-sided 95% CI, -2.64 to 0.77] percentage points; P < .001 for noninferiority). For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 8 patients (1.5%) in the P2Y12 inhibitor monotherapy group and in 12 patients (2.0%) in the DAPT group (absolute difference, -0.49 [95% CI, -2.07 to 1.09] percentage points; P = .54). Major bleeding occurred in 1 patient (0.2%) in the P2Y12 inhibitor monotherapy group and in 5 patients (0.8%) in the DAPT group (absolute difference, -0.60 [95% CI, -1.33 to 0.12] percentage points; P = .10). Conclusions and Relevance In patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations. Trial Registration ClinicalTrials.gov Identifier: NCT03447379.
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Affiliation(s)
- Pil-Ki Min
- Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Tae Soo Kang
- Division of Cardiology, Dankook University Hospital, Cheonan, Republic of Korea
| | - Yun-Hyeong Cho
- Division of Cardiology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
| | - Sang-Sig Cheong
- Department of Cardiology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea
| | - Byeong-Keuk Kim
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Sung Woo Kwon
- Division of Cardiology, Inha University Hospital, Incheon, Republic of Korea
| | - Woo Jung Park
- Division of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea
| | - Jung-Hee Lee
- Division of Cardiology, Yeungnam University Medical Center, Daegu, Republic of Korea
| | - Wonho Kim
- Eulji University School of Medicine, Daejeon, Republic of Korea
| | - Wang-Soo Lee
- Heart Research Institute, Chung-Ang University Hospital, Seoul, Republic of Korea
| | - Young Won Yoon
- Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Byoung Kwon Lee
- Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Hyuck Moon Kwon
- Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Bum-Kee Hong
- Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
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Hong SJ, Lee SJ, Suh Y, Yun KH, Kang TS, Shin S, Kwon SW, Lee JW, Cho DK, Park JK, Bae JW, Kang WC, Kim S, Lee YJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial. Circulation 2024; 149:562-573. [PMID: 37878786 DOI: 10.1161/circulationaha.123.066943] [Citation(s) in RCA: 55] [Impact Index Per Article: 55.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/30/2023] [Accepted: 10/06/2023] [Indexed: 10/27/2023]
Abstract
BACKGROUND Stopping aspirin within 1 month after implantation of a drug-eluting stent for ticagrelor monotherapy has not been exclusively evaluated for patients with acute coronary syndrome. The aim of this study was to investigate whether ticagrelor monotherapy after <1 month of dual antiplatelet therapy (DAPT) is noninferior to 12 months of ticagrelor-based DAPT for adverse cardiovascular and bleeding events in patients with acute coronary syndrome. METHODS In this randomized, open-label, noninferiority trial, 2850 patients with acute coronary syndrome who underwent drug-eluting stent implantation at 24 centers in South Korea were randomly assigned (1:1) to receive either ticagrelor monotherapy (90 mg twice daily) after <1 month of DAPT (n=1426) or 12 months of ticagrelor-based DAPT (n=1424) between April 24, 2019, and May 31, 2022. The primary end point was the net clinical benefit as a composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, stroke, and major bleeding at 1 year after the index procedure in the intention-to-treat population. Key secondary end points were the individual components of the primary end point. RESULTS Among 2850 patients who were randomized (mean age, 61 years; 40% ST-segment-elevation myocardial infarction), 2823 (99.0%) completed the trial. Aspirin was discontinued at a median of 16 days (interquartile range, 12-25 days) in the group receiving ticagrelor monotherapy after <1 month of DAPT. The primary end point occurred in 40 patients (2.8%) in the group receiving ticagrelor monotherapy after <1-month DAPT, and in 73 patients (5.2%) in the ticagrelor-based 12-month DAPT group (hazard ratio, 0.54 [95% CI, 0.37-0.80]; P<0.001 for noninferiority; P=0.002 for superiority). This finding was consistent in the per-protocol population as a sensitivity analysis. The occurrence of major bleeding was significantly lower in the ticagrelor monotherapy after <1-month DAPT group compared with the 12-month DAPT group (1.2% versus 3.4%; hazard ratio, 0.35 [95% CI, 0.20-0.61]; P<0.001). CONCLUSIONS This study provides evidence that stopping aspirin within 1 month for ticagrelor monotherapy is both noninferior and superior to 12-month DAPT for the 1-year composite outcome of death, myocardial infarction, stent thrombosis, stroke, and major bleeding, primarily because of a significant reduction in major bleeding, among patients with acute coronary syndrome receiving drug-eluting stent implantation. Low event rates, which may suggest enrollment of relatively non-high-risk patients, should be considered in interpreting the trial. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT03797651.
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Affiliation(s)
- Sung-Jin Hong
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Seung-Jun Lee
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Yongsung Suh
- Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea (Y.S.)
| | | | - Tae Soo Kang
- Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea (T.S.K.)
| | - Sanghoon Shin
- Ewha Womans University College of Medicine Seoul Hospital, Korea (S.S.)
| | | | - Jun-Won Lee
- Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Korea (J.-W.L.)
| | - Deok-Kyu Cho
- Yongin Severance Hospital, Yonsei University College of Medicine, Korea (D.-K.C.)
| | - Jong-Kwan Park
- National Health Insurance Service Ilsan Hospital, Goyang, Korea (J.-K.P.)
| | - Jang-Whan Bae
- Chungbuk National University College of Medicine, Cheongju, Korea (J.-W.B.)
| | | | - Seunghwan Kim
- Inje University Haeundae Paik Hospital, Busan, Korea (S.K.)
| | - Yong-Joon Lee
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Chul-Min Ahn
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Jung-Sun Kim
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Byeong-Keuk Kim
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Young-Guk Ko
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Donghoon Choi
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
| | - Yangsoo Jang
- CHA University College of Medicine, Seongnam, Korea (Y.J.)
| | - Myeong-Ki Hong
- Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (S.-J.H., S.-J.L., Y.-J.L., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., M.-K.H.)
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18
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Zhang X, Zhou D, Song S, Huang X, Ding Y, Meng R. Efficacy and Safety of Long-Term Dual Antiplatelet Therapy: A Systematic Review and Meta-Analysis. Clin Appl Thromb Hemost 2024; 30:10760296241244772. [PMID: 38571479 PMCID: PMC10993673 DOI: 10.1177/10760296241244772] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2024] [Revised: 03/04/2024] [Accepted: 03/18/2024] [Indexed: 04/05/2024] Open
Abstract
BACKGROUND Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is a standard therapy in patients with ischemic vascular diseases (IVD) including coronary artery, cerebrovascular and peripheral arterial diseases, although the optimal duration of this treatment is still debated. Previous meta-analyses reported conflicting results about the effects of long-term and short-term as well as non-DAPT use in various clinical settings. Herein, we conducted a comprehensive meta-analysis to assess the efficacy and safety of different durations of DAPT. METHODS We reviewed relevant articles and references from database, which were published prior to April 2023. Data from prospective studies were processed using RevMan5.0 software, provided by Cochrane Collaboration and transformed using relevant formulas. The inclusion criteria involved randomization to long-term versus short-term or no DAPT; the endpoints included at least one of total or cardiovascular (CV) mortalities, IVD recurrence, and bleeding. RESULTS A total of 34 randomized studies involving 141 455 patients were finally included. In comparison with no or short-term DAPT, long-term DAPT reduced MI and stroke, but did not reduce the total and CV mortalities. Meanwhile, bleeding events were increased, even though intracranial and fatal bleedings were not affected. Besides, the reduction of MI and stroke recurrence showed no statistical significance between long-term and short-term DAPT groups. CONCLUSION Long-term DAPT may not reduce the mortality of IVD besides increasing bleeding events, although reduced the incidences of MI and stroke early recurrence to a certain extent and did not increase the risk of fatal intracranial bleeding.
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Affiliation(s)
- Xiaoming Zhang
- Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China
- Advanced Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China
- National Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Da Zhou
- Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China
- Advanced Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China
- National Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Siying Song
- Division of Neurocritical Care and Emergency Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
| | - Xiangqian Huang
- Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China
- Advanced Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China
- National Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Yuchuan Ding
- Department of Neurosurgery, Wayne State University School of Medicine, Detroit, MI, USA
| | - Ran Meng
- Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China
- Advanced Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China
- National Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China
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19
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Tang KS, Banerjee S, Tang G, Patel PM, Frangieh AH. Shortened Duration of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Contemporary Clinical Review. Interv Cardiol 2023; 18:e31. [PMID: 38213748 PMCID: PMC10782423 DOI: 10.15420/icr.2023.19] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2023] [Accepted: 10/08/2023] [Indexed: 01/13/2024] Open
Abstract
Percutaneous coronary intervention with stent implantation is an integral aspect of minimally interventional cardiac procedures. The technology and techniques behind stent design and implantation have evolved rapidly over several decades. However, continued discourse remains around optimal peri- and post-interventional management with dual antiplatelet therapy to minimise both major cardiovascular or cerebrovascular events and iatrogenic bleeding risk. Standard guidelines around dual antiplatelet therapy historically recommended long-term dual antiplatelet therapy for 12 months (with consideration for >12 months in certain patients); however, emerging data and generational improvements in the safety of drug-eluting stents have ushered in a new era of short-term therapy to reduce the incidence of major bleeding events. This case review will provide an overview of the current state of guidelines around duration of dual antiplatelet therapy and examine recent updates and continued gaps in existing research.
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Affiliation(s)
- Kevin S Tang
- Division of Internal Medicine, Department of Medicine, University of California Irvine HealthOrange, CA, US
| | - Shoujit Banerjee
- Division of Internal Medicine, Department of Medicine, University of California Irvine HealthOrange, CA, US
| | - George Tang
- Division of Cardiology, Department of Medicine, University of California Irvine HealthOrange, CA, US
| | - Pranav M Patel
- Division of Cardiology, Department of Medicine, University of California Irvine HealthOrange, CA, US
| | - Antonio H Frangieh
- Division of Cardiology, Department of Medicine, University of California Irvine HealthOrange, CA, US
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20
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De Luca L, Gragnano F, Calabrò P, Huber K. Balancing Benefits and Risks of Oral Antiplatelet Strategies in patients With Coronary Artery Diseases: An Evolving Issue. Curr Probl Cardiol 2023; 48:102025. [PMID: 37553063 DOI: 10.1016/j.cpcardiol.2023.102025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2023] [Accepted: 08/04/2023] [Indexed: 08/10/2023]
Abstract
Identifying the most appropriate antiplatelet therapy for each patient to prevent ischemic events while minimizing the risk of bleeding is an integral part of the short- and long-term management of patients with coronary artery disease (CAD). This review aims to summarize the available evidence on the contemporary use of P2Y12 inhibitors in CAD patients, focusing on strategies aimed at providing adequate ischemic protection while preventing bleeding risk through dual antiplatelet therapy (DAPT) modulation. Randomized trials and observational studies have been reviewed to determine the most appropriate antiplatelet treatment for CAD patients with different risk profiles. Both ischemic and bleeding events have a significant prognostic impact and should be carefully considered in clinical decision-making. Current guidelines recommend the use of third-generation PY2Y12 inhibitors (prasugrel or ticagrelor) over clopidogrel, as a part of DAPT, in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention. Newer P2Y12 inhibitors have a more rapid onset of action and less interindividual variability in platelet inhibition than clopidogrel but are associated with an increased risk of bleeding that may limit their benefit. Importantly, the anti-ischemic benefit of ticagrelor and prasugrel is mainly observed in the first weeks after ACS, whereas clopidogrel seems to provide the best balance between ischemic protection and bleeding as long-term maintenance therapy. These concepts support DAPT modulation after the acute phase, by de-escalating from full-dose to low-dose newer P2Y12 inhibitors, by switching to clopidogrel, or by early withdrawing aspirin to maximize both the efficacy and safety of antiplatelet therapy in patients with CAD.
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Affiliation(s)
- Leonardo De Luca
- Division of Cardiology, Department of Cardiosciences, A.O. San Camillo-Forlanini, Roma, Italy.
| | - Felice Gragnano
- Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy; Division of Cardiology, AORN "Sant'anna e San Sebastiano", Caserta, Italy
| | - Paolo Calabrò
- Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy; Division of Cardiology, AORN "Sant'anna e San Sebastiano", Caserta, Italy
| | - Kurt Huber
- Department of Cardiology and Intensive Care Medicine, Clinic Ottakring, and Sigmund Freud University, Medical Faculty, Vienna, Austria
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21
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Hickson RP, Kucharska-Newton AM, Rodgers JE, Sleath BL, Fang G. Optimal P2Y 12 inhibitor durations in older men and older women following an acute myocardial infarction: A nationwide cohort study using Medicare data. AMERICAN HEART JOURNAL PLUS : CARDIOLOGY RESEARCH AND PRACTICE 2023; 36:100339. [PMID: 38487715 PMCID: PMC10939016 DOI: 10.1016/j.ahjo.2023.100339] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/30/2022] [Revised: 10/26/2023] [Accepted: 10/26/2023] [Indexed: 03/17/2024]
Abstract
Study objective Identify optimal P2Y12 inhibitor durations balancing ischemic-benefit and bleeding-risk outcomes after acute myocardial infarction (AMI) in older men and women. Design Observational retrospective cohort with 2 years of follow-up, using clone-censor-weight marginal structural models to emulate randomization. Setting 20 % sample of US Medicare administrative claims data. Participants P2Y12 inhibitor new users ≥66 years old following 2008-2013 AMI hospitalization. Exposures 12- to 24-month P2Y12 inhibitor durations in 1-month intervals. Main outcome measures Effectiveness outcome (composite of all-cause mortality, recurrent AMI, ischemic stroke), safety outcome (hospitalized bleed), and negative control outcome (heart failure hospitalization). Results Of 28,488 P2Y12 inhibitor new users, 51 % were female, 50 % were > 75 years old, 88 % were White/non-Hispanic, and 93 % initiated clopidogrel. Negative control outcome results for 16- through 24-month durations appeared most likely to meet assumptions of no unmeasured confounding. Compared to men taking 24-month therapy, men taking 16-month therapy had higher 2-year risks of the composite effectiveness outcome (relative risk [RR] = 1.08; 95 % confidence interval [95%CI]:1.00-1.15) with similar bleeding risks (RR = 0.98; 95%CI:0.85-1.13). Compared to women taking 24-month therapy, women taking 16-month therapy had similar 2-year risks of the composite effectiveness outcome (RR = 0.98; 95%CI:0.92-1.04) and lower bleeding risks (RR = 0.88; 95%CI:0.80-0.96). Conclusions Older men taking 24-month P2Y12 inhibitor therapy had the lowest composite effectiveness outcome risk with no increased bleeding risk compared to shorter durations. Women taking 16-month versus 24-month P2Y12 inhibitor therapy had similar composite effectiveness outcome risks but a substantially lower hospitalized bleeding risk, suggesting durations beyond 15-17 months lacked benefit while increasing bleeding risk.
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Affiliation(s)
- Ryan P. Hickson
- Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, United States of America
- Department of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, United States of America
- Geriatric Research, Education, and Clinical Center, Veterans Affairs Pittsburgh Healthcare System, United States of America
- Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, United States of America
- Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, United States of America
| | - Anna M. Kucharska-Newton
- Department of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, United States of America
- Department of Epidemiology, College of Public Health, University of Kentucky, United States of America
| | - Jo E. Rodgers
- Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, United States of America
| | - Betsy L. Sleath
- Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, United States of America
| | - Gang Fang
- Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, United States of America
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22
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Gorog DA, Ferreiro JL, Ahrens I, Ako J, Geisler T, Halvorsen S, Huber K, Jeong YH, Navarese EP, Rubboli A, Sibbing D, Siller-Matula JM, Storey RF, Tan JWC, Ten Berg JM, Valgimigli M, Vandenbriele C, Lip GYH. De-escalation or abbreviation of dual antiplatelet therapy in acute coronary syndromes and percutaneous coronary intervention: a Consensus Statement from an international expert panel on coronary thrombosis. Nat Rev Cardiol 2023; 20:830-844. [PMID: 37474795 DOI: 10.1038/s41569-023-00901-2] [Citation(s) in RCA: 32] [Impact Index Per Article: 16.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 06/07/2023] [Indexed: 07/22/2023]
Abstract
Conventional dual antiplatelet therapy (DAPT) for patients with acute coronary syndromes undergoing percutaneous coronary intervention comprises aspirin with a potent P2Y purinoceptor 12 (P2Y12) inhibitor (prasugrel or ticagrelor) for 12 months. Although this approach reduces ischaemic risk, patients are exposed to a substantial risk of bleeding. Strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. Either strategy requires assessment of the ischaemic and bleeding risks of each individual. De-escalation of DAPT intensity can reduce bleeding without increasing ischaemic events and can be guided by platelet function testing or genotyping. Abbreviation of DAPT duration after 1-6 months, followed by monotherapy with aspirin or a P2Y12 inhibitor, reduces bleeding without an increase in ischaemic events in patients at high bleeding risk, particularly those without high ischaemic risk. However, these two strategies have not yet been compared in a head-to-head clinical trial. In this Consensus Statement, we summarize the evidence base for these treatment approaches, provide guidance on the assessment of ischaemic and bleeding risks, and provide consensus statements from an international panel of experts to help clinicians to optimize these DAPT approaches for individual patients to improve outcomes.
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Affiliation(s)
- Diana A Gorog
- Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, UK.
- Centre for Health Services Research, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK.
| | - Jose Luis Ferreiro
- Department of Cardiology, Hospital Universitario de Bellvitge, CIBERCV, L'Hospitalet de Llobregat, Spain
- Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain
| | - Ingo Ahrens
- Department of Cardiology and Medical Intensive Care, Augustinerinnen Hospital Cologne, Academic Teaching Hospital University of Cologne, Cologne, Germany
- Faculty of Medicine, University of Freiburg, Freiburg, Germany
| | - Junya Ako
- Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan
| | - Tobias Geisler
- Department of Cardiology and Angiology, University Hospital, Eberhard-Karls-University Tuebingen, Tuebingen, Germany
| | - Sigrun Halvorsen
- Department of Cardiology, Oslo University Hospital Ulleval, Oslo, Norway
- University of Oslo, Oslo, Norway
| | - Kurt Huber
- 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, Vienna, Austria
- Medical Faculty, Sigmund Freud University, Vienna, Austria
| | - Young-Hoon Jeong
- CAU Thrombosis and Biomarker Center, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Republic of Korea
- Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea
| | - Eliano P Navarese
- Interventional Cardiology and Cardiovascular Medicine Research, Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland
- Faculty of Medicine, University of Alberta, Edmonton, Alberta, Canada
| | - Andrea Rubboli
- Department of Emergency, Internal Medicine and Cardiology, Division of Cardiology, S. Maria delle Croci Hospital, Ravenna, Italy
| | - Dirk Sibbing
- Ludwig-Maximilians University München, Munich, Germany
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), partner site Munich Heart Alliance, Munich, Germany
- Privatklinik Lauterbacher Mühle am Ostsee, Seeshaupt, Germany
| | | | - Robert F Storey
- Cardiovascular Research Unit, Department of Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK
| | - Jack W C Tan
- National Heart Centre Singapore and Sengkang General Hospital, Singapore, Singapore
| | - Jurrien M Ten Berg
- St Antonius Hospital, Nieuwegein, The Netherlands
- Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands
| | - Marco Valgimigli
- Cardiocentro Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana (USI), Lugano, Switzerland
- University of Bern, Bern, Switzerland
| | | | - Gregory Y H Lip
- Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University, Liverpool, UK
- Liverpool Heart & Chest Hospital, Liverpool, UK
- Danish Center for Clinical Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
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23
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Oliva A, Cao D, Spirito A, Nicolas J, Pileggi B, Kamaleldin K, Vogel B, Mehran R. Personalized Approaches to Antiplatelet Treatment for Cardiovascular Diseases: An Umbrella Review. Pharmgenomics Pers Med 2023; 16:973-990. [PMID: 37941790 PMCID: PMC10629404 DOI: 10.2147/pgpm.s391400] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/07/2023] [Accepted: 08/21/2023] [Indexed: 11/10/2023] Open
Abstract
Antiplatelet therapy is the cornerstone of antithrombotic prevention in patients with established atherosclerosis, since it has been proven to reduce coronary, cerebrovascular, and peripheral thrombotic events. However, the protective effect of antiplatelet agents is counterbalanced by an increase of bleeding events that impacts on patients' mortality and morbidity. Over the last years, great efforts have been made toward personalized antithrombotic strategies according to the individual bleeding and ischemic risk profile, aiming to maximizing the net clinical benefit. The development of risk scores, consensus definitions, and the new promising artificial intelligence tools, as well as the assessment of platelet responsiveness using platelet function and genetic testing, are now part of an integrated approach to tailored antithrombotic management. Moreover, novel strategies are available including dual antiplatelet therapy intensity and length modulation in patients undergoing myocardial revascularization, the use of P2Y12 inhibitor monotherapy for long-term secondary prevention, the implementation of parenteral antiplatelet agents in high-ischemic risk clinical settings, and combination of antiplatelet agents with low-dose factor Xa inhibitors (dual pathway inhibition) in patients suffering from polyvascular disease. This review summarizes the currently available evidence and provides an overview of the principal risk-stratification tools and antiplatelet strategies to inform treatment decisions in patients with cardiovascular disease.
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Affiliation(s)
- Angelo Oliva
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
- Cardio Center, Humanitas Research Hospital IRCCS Rozzano, Milan, Italy
| | - Davide Cao
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy
| | - Alessandro Spirito
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
| | - Johny Nicolas
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
| | - Brunna Pileggi
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
- Department of Cardiopneumonology, Heart Institute of the University of Sao Paulo, Sao Paulo, Brazil
| | - Karim Kamaleldin
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
| | - Birgit Vogel
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
| | - Roxana Mehran
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
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24
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Marx N, Federici M, Schütt K, Müller-Wieland D, Ajjan RA, Antunes MJ, Christodorescu RM, Crawford C, Di Angelantonio E, Eliasson B, Espinola-Klein C, Fauchier L, Halle M, Herrington WG, Kautzky-Willer A, Lambrinou E, Lesiak M, Lettino M, McGuire DK, Mullens W, Rocca B, Sattar N. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J 2023; 44:4043-4140. [PMID: 37622663 DOI: 10.1093/eurheartj/ehad192] [Citation(s) in RCA: 546] [Impact Index Per Article: 273.0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/26/2023] Open
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25
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Kuno T, Watanabe A, Shoji S, Fujisaki T, Ueyama H, Takagi H, Deharo P, Cuisset T, Bangalore S, Mehran R, Stone GW, Kohsaka S, Bhatt DL. Short-Term DAPT and DAPT De-Escalation Strategies for Patients With Acute Coronary Syndromes: A Systematic Review and Network Meta-Analysis. Circ Cardiovasc Interv 2023; 16:e013242. [PMID: 37609850 DOI: 10.1161/circinterventions.123.013242] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/10/2023] [Accepted: 07/13/2023] [Indexed: 08/24/2023]
Abstract
BACKGROUND Short-term (≤6 months) dual antiplatelet therapy (DAPT) and DAPT de-escalation become attractive for patients with acute coronary syndrome. METHODS A systemic search identified randomized controlled trials that included patients with acute coronary syndrome treated using (1) standard DAPT (12 months) with clopidogrel, prasugrel (standard/low dose), or ticagrelor; (2) extended DAPT (≥18 months); (3) short-term DAPT (≤6 months) followed by P2Y12 inhibitor or aspirin; (4) 12-month DAPT with unguided de-escalation from potent P2Y12 inhibitors to low-dose potent P2Y12 inhibitor or clopidogrel at 1 month; and (5) guided selection DAPT with genotype or platelet function tests. The primary efficacy outcome (major adverse cardiovascular events) was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major or minor bleeding. RESULTS This meta-analysis included 32 randomized controlled trials with 103 497 patients. While there were no differences in efficacy between short, unguided de-escalation and guided selection strategies, unguided de-escalation was associated with reduced risk of major adverse cardiovascular events compared with standard DAPT with clopidogrel or ticagrelor (hazard ratio [95% CI], 0.67 [0.49-0.93] and 0.68 [0.50-0.93]). Both short DAPT followed by P2Y12 inhibitor and unguided de-escalation were associated with reduced risks in safety compared with other strategies, including guided selection (hazard ratio [95% CI], 0.66 [0.47-0.93] and 0.48 [0.33-0.71]). Short DAPT followed by a P2Y12 inhibitor was associated with reduced risk of major bleeding and all-cause death compared with standard, extended DAPT (eg, versus DAPT with clopidogrel; hazard ratio [95% CI], 0.64 [0.42-0.97] and 0.60 [0.44-0.82]). By rankogram, unguided de-escalation strategy was the safest and most effective strategy in reducing major adverse cardiovascular events and major or minor bleeding while short DAPT followed by P2Y12 inhibitor was ranked the best for major bleeding and all-cause death. CONCLUSIONS In patients with acute coronary syndrome, unguided de-escalation was associated with the lowest risk of major adverse cardiovascular events and major or minor bleeding outcomes, while short DAPT followed by P2Y12 inhibitor was associated with the lowest risk of major bleeding and all-cause death.
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Affiliation(s)
- Toshiki Kuno
- Division of Cardiology, Montefiore Medical Center (T.K.), Jacobi Medical Center, Albert Einstein College of Medicine, New York, NY
- Division of Cardiology (T.K.), Jacobi Medical Center, Albert Einstein College of Medicine, New York, NY
| | - Atsuyuki Watanabe
- Department of Medicine, Mount Sinai Beth Israel (A.W.), Icahn School of Medicine at Mount Sinai, New York, NY
| | - Satoshi Shoji
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan (S.S., S.K.)
- Duke Clinical Research Institute, Durham, NC (S.S.)
| | - Tomohiro Fujisaki
- Department of Medicine, Mount Sinai Morningside and West (T.F.), Icahn School of Medicine at Mount Sinai, New York, NY
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Japan (T.F.)
- Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan (T.F.)
| | - Hiroki Ueyama
- Division of Cardiology, Emory University School of Medicine, Atlanta, GA (H.U.)
| | - Hisato Takagi
- Department of Cardiovascular Surgery, Shizuoka Medical Center, Japan (H.T.)
| | - Pierre Deharo
- Département de Cardiologie, CHU Timone, Marseille, France (P.D., T.C.)
- INSERM, INRA, C2VN (P.D., T.C.), Aix-Marseille Université, France
- Faculté de Médecine (P.D., T.C.), Aix-Marseille Université, France
| | - Thomas Cuisset
- Département de Cardiologie, CHU Timone, Marseille, France (P.D., T.C.)
- INSERM, INRA, C2VN (P.D., T.C.), Aix-Marseille Université, France
- Faculté de Médecine (P.D., T.C.), Aix-Marseille Université, France
| | - Sripal Bangalore
- Leon H. Charney Division of Cardiovascular Medicine, New York University Grossman School of Medicine (S.B.)
| | - Roxana Mehran
- The Zena and Michael A. Wiener Cardiovascular Institute (R.M., G.W.S.), Icahn School of Medicine at Mount Sinai, New York, NY
| | - Gregg W Stone
- The Zena and Michael A. Wiener Cardiovascular Institute (R.M., G.W.S.), Icahn School of Medicine at Mount Sinai, New York, NY
| | - Shun Kohsaka
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan (S.S., S.K.)
| | - Deepak L Bhatt
- Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY (D.L.B.)
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26
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Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, Hess B, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, van Diepen S, Wiggins B, Williams MS. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2023; 82:833-955. [PMID: 37480922 DOI: 10.1016/j.jacc.2023.04.003] [Citation(s) in RCA: 163] [Impact Index Per Article: 81.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 07/24/2023]
Abstract
AIM The "2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease" provides an update to and consolidates new evidence since the "2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease" and the corresponding "2014 ACC/AHA/AATS/PCNA/SCAI/STS Focused Update of the Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease." METHODS A comprehensive literature search was conducted from September 2021 to May 2022. Clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants were identified that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. STRUCTURE This guideline provides an evidenced-based and patient-centered approach to management of patients with chronic coronary disease, considering social determinants of health and incorporating the principles of shared decision-making and team-based care. Relevant topics include general approaches to treatment decisions, guideline-directed management and therapy to reduce symptoms and future cardiovascular events, decision-making pertaining to revascularization in patients with chronic coronary disease, recommendations for management in special populations, patient follow-up and monitoring, evidence gaps, and areas in need of future research. Where applicable, and based on availability of cost-effectiveness data, cost-value recommendations are also provided for clinicians. Many recommendations from previously published guidelines have been updated with new evidence, and new recommendations have been created when supported by published data.
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27
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Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, Hess B, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, van Diepen S, Wiggins B, Williams MS. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation 2023; 148:e9-e119. [PMID: 37471501 DOI: 10.1161/cir.0000000000001168] [Citation(s) in RCA: 462] [Impact Index Per Article: 231.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 07/22/2023]
Abstract
AIM The "2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease" provides an update to and consolidates new evidence since the "2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease" and the corresponding "2014 ACC/AHA/AATS/PCNA/SCAI/STS Focused Update of the Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease." METHODS A comprehensive literature search was conducted from September 2021 to May 2022. Clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants were identified that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. STRUCTURE This guideline provides an evidenced-based and patient-centered approach to management of patients with chronic coronary disease, considering social determinants of health and incorporating the principles of shared decision-making and team-based care. Relevant topics include general approaches to treatment decisions, guideline-directed management and therapy to reduce symptoms and future cardiovascular events, decision-making pertaining to revascularization in patients with chronic coronary disease, recommendations for management in special populations, patient follow-up and monitoring, evidence gaps, and areas in need of future research. Where applicable, and based on availability of cost-effectiveness data, cost-value recommendations are also provided for clinicians. Many recommendations from previously published guidelines have been updated with new evidence, and new recommendations have been created when supported by published data.
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Affiliation(s)
| | | | | | | | | | | | - Dave L Dixon
- Former Joint Committee on Clinical Practice Guideline member; current member during the writing effort
| | - William F Fearon
- Society for Cardiovascular Angiography and Interventions representative
| | | | | | | | - Dhaval Kolte
- AHA/ACC Joint Committee on Clinical Data Standards
| | | | | | | | - Daniel B Mark
- Former Joint Committee on Clinical Practice Guideline member; current member during the writing effort
| | | | | | | | - Mariann R Piano
- Former Joint Committee on Clinical Practice Guideline member; current member during the writing effort
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28
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Arockiam S, Staniforth B, Kepreotis S, Maznyczka A, Bulluck H. A Contemporary Review of Antiplatelet Therapies in Current Clinical Practice. Int J Mol Sci 2023; 24:11132. [PMID: 37446310 DOI: 10.3390/ijms241311132] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2023] [Revised: 07/03/2023] [Accepted: 07/04/2023] [Indexed: 07/15/2023] Open
Abstract
Antiplatelet therapy plays a crucial role in a number of cardiovascular disorders. We currently have a range of antiplatelet agents in our armamentarium. In this review, we aim to summarise the common antiplatelet agents currently available, and their use in clinic practice. We not only highlight recent trials exploring antiplatelet therapy in atherosclerotic cardiovascular disease, but also in trials related to transcatheter aortic valve implantation and coronavirus disease 2019. Inevitably, the antithrombotic benefits of these drugs are accompanied by an increase in bleeding complications. Therefore, an individualised approach to weighing each patient's thrombotic risk versus bleeding risk is imperative, in order to improve clinical outcomes.
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Affiliation(s)
- Sacchin Arockiam
- Yorkshire Heart Centre, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds LS2 3AX, UK
| | - Brittany Staniforth
- Yorkshire Heart Centre, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds LS2 3AX, UK
| | - Sacha Kepreotis
- Yorkshire Heart Centre, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds LS2 3AX, UK
| | - Annette Maznyczka
- Yorkshire Heart Centre, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds LS2 3AX, UK
| | - Heerajnarain Bulluck
- Yorkshire Heart Centre, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds LS2 3AX, UK
- Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds LS2 9JT, UK
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Shpigelman J, Proshkina A, Daly MJ, Cox D. Personalized Dual Antiplatelet Therapy in Acute Coronary Syndromes: Striking a Balance Between Bleeding and Thrombosis. Curr Cardiol Rep 2023; 25:693-710. [PMID: 37261665 PMCID: PMC10307718 DOI: 10.1007/s11886-023-01892-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/05/2023] [Indexed: 06/02/2023]
Abstract
PURPOSE OF REVIEW Dual antiplatelet therapy (DAPT)-aspirin in conjunction with a P2Y12 inhibitor-is the cornerstone of managing patients with acute coronary syndromes post-revascularization, but the clinical response is highly variable, with potentially devastating consequences. Herein, we review the mechanisms underpinning said variability and explore emerging approaches to normalizing therapeutic benefit. RECENT FINDINGS The potent P2Y12 inhibitors, prasugrel and ticagrelor, exhibit minimal inter-individual variability, replacing clopidogrel in DAPT and achieving greater rates of therapeutic response. However, these benefits decline in later phases when bleeding risk begins to supersede that of ischemia. Guided de-escalation of P2Y12 inhibition as well as shortening DAPT duration have emerged as strategies that retain antithrombotic efficacy while reducing bleeding risk. Aspirin is the other component of DAPT but is also used in isolation for secondary prevention of thrombotic disease. In contrast to the P2Y12 inhibitors, genetic influences on aspirin non-response appear to be outweighed by a triad of clinical factors: non-adherence, enteric aspirin use, and inappropriate dosing according to bodyweight and BMI. Multiple de-escalation strategies for DAPT have been shown to mitigate bleeding risk, but it remains unclear which approach is ideal, necessitating head-to-head investigations to determine which exhibits the most favorable cost-to-benefit ratio. However, there is likely a role for more than one approach in clinical practice, depending on patient risk profile. Our approach to aspirin use is also in need of reassessment: strategies to improve adherence, avoidance of enteric aspirin in cardiac patients, and dose adjustment according to bodyweight and/or BMI are all likely to improve rates of therapeutic response. Moreover, platelet function testing may have a role in identifying patients expected to benefit from primary prophylactic aspirin.
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Affiliation(s)
| | | | - Michael J Daly
- School of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland
- Department of Cardiology, Connolly Hospital, Blanchardstown, Dublin, Ireland
| | - Dermot Cox
- School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland
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Otieno B, Ibecheozor C, Williams MS. What Is the Optimal Duration of Antiplatelet Therapy for Patients with Coronary Heart Disease? Curr Atheroscler Rep 2023:10.1007/s11883-023-01108-z. [PMID: 37178416 DOI: 10.1007/s11883-023-01108-z] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/22/2023] [Indexed: 05/15/2023]
Abstract
PURPOSE OF REVIEW Optimal duration of antiplatelet therapy continues to attract extensive debates and has been progressively adjusted in the setting of advancements in stent design and assessment of patient clinical characteristics. Given the ever-changing landscape of antiplatelet therapy and the multitude of clinical trials that have examined this duration, there are varying scenarios for optimal duration based on patient presentation and risk profile. This review highlights the current concepts and recommendations regarding duration of antiplatelet therapy in coronary heart disease. RECENT FINDINGS In particular, we review the current data on the use of dual antiplatelet therapy in the different clinical scenarios. Relatively longer dual antiplatelet therapy is perhaps limited to patients with higher risk for cardiovascular events and/or high-risk lesions and shorter durations of dual antiplatelet therapy have been shown to reduce bleeding complications at the same time as stabilization of ischemic endpoints. More recent trials have demonstrated the safety of shorter durations of dual antiplatelet therapy in appropriate patients with coronary heart disease.
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Affiliation(s)
- Beryl Otieno
- Greater Baltimore Medical Center, Towson, MD, USA
| | | | - Marlene S Williams
- Division of Cardiology, The Johns Hopkins University School of Medicine, 301 Mason Lord Drive, Suite 2400, Baltimore, MD, 21224, USA.
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Structural and temporal dynamics analysis on drug-eluting stents: History, research hotspots and emerging trends. Bioact Mater 2023; 23:170-186. [DOI: 10.1016/j.bioactmat.2022.09.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/15/2022] [Revised: 09/04/2022] [Accepted: 09/12/2022] [Indexed: 11/13/2022] Open
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Gorog DA, Jeyalan V, Markides RIL, Navarese EP, Jeong YH, Farag M. Comparison of De-escalation of DAPT Intensity or Duration in East Asian and Western Patients with ACS Undergoing PCI: A Systematic Review and Meta-analysis. Thromb Haemost 2023. [PMID: 37072035 DOI: 10.1055/s-0043-57030] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/20/2023]
Abstract
BACKGROUND Guideline-recommended dual antiplatelet therapy (DAPT; aspirin plus prasugrel/ticagrelor) for 12 months in acute coronary syndrome (ACS) patients increases bleeding, with East Asians (EAs) exhibiting higher bleeding and lower ischemic risk, compared with non-East Asians (nEAs). We sought to compare DAPT "de-escalation" strategies in EA and nEA populations. METHODS A systematic review and meta-analysis of randomized controlled trials assessing reduction of DAPT intensity or duration in ACS patients undergoing percutaneous coronary intervention, in EA and nEA, was performed using a random-effects model. RESULTS Twenty-three trials assessed reduction of DAPT intensity (n = 12) or duration (n = 11). Overall, reduced DAPT intensity attenuated major bleeding (odds ratio [OR]: 0.78, 95% confidence interval [CI]: 0.65-0.94, p = 0.009), without impacting net adverse cardiovascular events (NACE) or major adverse cardiovascular events (MACE). In nEA, this increased MACE (OR: 1.20, 95% CI: 1.09-1.31, p < 0.0001) without impacting NACE or bleeding; while in EA, it reduced major bleeding (OR: 0.71, 95% CI: 0.53-0.95, p = 0.02) without affecting NACE or MACE. Overall, abbreviation of DAPT duration reduced NACE (OR: 0.90, 95% CI: 0.82-0.99, p = 0.03) due to major bleeding (OR: 0.69, 95% CI: 0.53-0.99, p = 0.006), without impacting MACE. In nEA, this strategy did not impact NACE, MACE, or major bleeding; while in EA, it reduced major bleeding (OR: 0.60, 95% CI: 0.4-0.91, p = 0.02) without impacting NACE or MACE. CONCLUSION In EA, reduction of DAPT intensity or duration can minimize bleeding, without safety concerns. In nEA, reduction of DAPT intensity may incur an ischemic penalty, while DAPT abbreviation has no overall benefit.
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Affiliation(s)
- Diana A Gorog
- Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom
- Centre for Health Services and Clinical Research, Postgraduate Medical School, University of Hertfordshire, Hertfordshire, United Kingdom
| | - Visvesh Jeyalan
- Department of Cardiology, Freeman Hospital, Newcastle-upon-Tyne, United Kingdom
| | - Rafaella I L Markides
- University of Cambridge School of Clinical Medicine, University of Cambridge, Cambridgeshire, United Kingdom
| | - Eliano P Navarese
- Interventional Cardiology and Cardiovascular Medicine Research, Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland
- Department of Cardiology, Faculty of Medicine, University of Alberta, Edmonton, Canada
| | - Young-Hoon Jeong
- CAU Thrombosis and Biomarker Center, Chung-Ang University, Gwangmyeong Hospital, Seoul, Republic of Korea
- Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea
| | - Mohamed Farag
- Centre for Health Services and Clinical Research, Postgraduate Medical School, University of Hertfordshire, Hertfordshire, United Kingdom
- Department of Cardiology, Freeman Hospital, Newcastle-upon-Tyne, United Kingdom
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Sabouret P, Spadafora L, Fischman D, Ullah W, Zeitouni M, Gulati M, De Rosa S, Savage MP, Costabel JP, Banach M, Biondi-Zoccai G, Galli M. De-escalation of antiplatelet therapy in patients with coronary artery disease: Time to change our strategy? Eur J Intern Med 2023; 110:1-9. [PMID: 36575107 DOI: 10.1016/j.ejim.2022.12.008] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/05/2022] [Revised: 12/14/2022] [Accepted: 12/16/2022] [Indexed: 12/26/2022]
Abstract
Dual antiplatelet therapy (DAPT) is the gold standard after acute coronary syndromes (ACS) or chronic coronary syndromes (CCS) undergoing percutaneous coronary intervention (PCI). Because local and systemic ischemic complications can occur particularly in the early phase (i.e. 1-3 months) after ACS or PCI, the synergistic platelet inhibition of aspirin and a P2Y12 inhibitor is of the utmost importance in this early phase. Moreover, the use of the more potent P2Y12 inhibitors prasugrel and ticagrelor have shown to further reduce the incidence of ischemic events compared to clopidogrel after an ACS. On the other hand, prolonged and potent antiplatelet therapy are inevitably associated with increased bleeding, which unlike thrombotic risk, tends to be stable over time and may outweigh the benefit of reducing ischemic events in these patients. The duration and composition of antiplatelet therapy remains a topic of debate in cardiology due to competing ischemic and bleeding risks, with guidelines and recommendations considerably evolving in the past years. An emerging strategy, called "de-escalation", consisting in the administration of a less intense antithrombotic therapy after a short course of standard DAPT, has shown to reduce bleeding without any trade-off in ischemic events. De-escalation may be achieved with different antithrombotic strategies and can be either unguided or guided by platelet function or genetic testing. The aim of this review is to summarize the evidence and provide practical recommendations on the use of different de-escalation strategies in patients with ACS and CCS.
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Affiliation(s)
- Pierre Sabouret
- Heart Institute, ACTION Study Group-CHU Pitié-Salpétrière, 47-83 Boulevard de l'Hôpital, Paris, France; Collège National des Cardiologues Français (CNCF), Paris, France.
| | - Luigi Spadafora
- Department of Clinical, Internal Medicine, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Italy
| | - David Fischman
- Thomas Jefferson University Hospitals, Philadelphia, PA, USA
| | - Waqas Ullah
- Thomas Jefferson University Hospitals, Philadelphia, PA, USA
| | - Michel Zeitouni
- Heart Institute, ACTION Study Group-CHU Pitié-Salpétrière, 47-83 Boulevard de l'Hôpital, Paris, France
| | - Martha Gulati
- Barbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, USA
| | | | | | - Juan Pablo Costabel
- Division of Cardiology, Instituto Cardiovascular de Buenos Aires (ICBA), Buenos Aires, Argentina
| | - Maciej Banach
- Department of Preventive Cardiology and Lipidology, Medical University of Lodz and Polish Mother's Memorial Hospital Research Institute, Lodz, Poland
| | - Giuseppe Biondi-Zoccai
- Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy
| | - Mattia Galli
- Catholic University of the Sacred Heart, Rome, Italy; Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy
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Greco A, Finocchiaro S, Angiolillo DJ, Capodanno D. Advances in the available pharmacotherapy for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Expert Opin Pharmacother 2023; 24:453-471. [PMID: 36693142 DOI: 10.1080/14656566.2023.2171788] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2022] [Accepted: 01/19/2023] [Indexed: 01/26/2023]
Abstract
INTRODUCTION Non-ST-segment elevation acute coronary syndromes (NSTE-ACS), including non-ST-segment-elevation myocardial infarction (NSTEMI) and unstable angina, represent a leading cause of mortality worldwide, with important socio-economic consequences. NSTEMI accounts for the majority of acute coronary syndromes and usually develops on the background of a nonocclusive thrombus. We searched for relevant literature in the field in PubMed and clinicaltrials.gov as of July 2022. AREAS COVERED A number of pharmacotherapies are currently available for treatment and secondary prevention, mainly including antithrombotic, lipid-lowering and anti-inflammatory drugs. Pretreatment with aspirin, anticoagulant and statin therapy is of key importance in the preprocedural phase, while pretreating with an oral P2Y12 inhibitor is not routinely indicated in patients undergoing early invasive management. For patients undergoing percutaneous coronary revascularization, pharmacotherapy essentially consists of antithrombotic drugs, which should be carefully selected. Finally, antithrombotic, lipid-lowering and anti-inflammatory drugs are important components of long-term secondary prevention after a NSTE-ACS. EXPERT OPINION This article reviews the evidence supporting recommendation on pharmacotherapy in patients presenting with a NSTE-ACS. Several randomized clinical trials are still ongoing and are expected to further inform scientific knowledge and clinical practice, with the final aim to improve the treatment of NSTE-ACS patients.
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Affiliation(s)
- Antonio Greco
- Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco," University of Catania, Catania, Italy
| | - Simone Finocchiaro
- Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco," University of Catania, Catania, Italy
| | - Dominick J Angiolillo
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Davide Capodanno
- Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco," University of Catania, Catania, Italy
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Rout A, Sharma A, Ikram S, Garg A. Short-term dual antiplatelet therapy for 1-3 months after percutaneous coronary intervention using drug eluting stents: A systematic review and meta-analysis of randomized clinical trials. Catheter Cardiovasc Interv 2023; 101:299-307. [PMID: 36490229 DOI: 10.1002/ccd.30521] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/31/2022] [Accepted: 11/20/2022] [Indexed: 02/17/2024]
Abstract
BACKGROUND The optimal dual antiplatelet therapy (DAPT) duration and regimen in patients undergoing percutaneous coronary intervention (PCI) using current generation drug eluting stents (DES) is still unclear. AIMS To compare the safety and efficacy of short-term DAPT (S-DAPT) with longer duration DAPT (l-DAPT) after contemporary PCI. METHODS We searched for studies comparing S-DAPT (≤3 months) followed by single antiplatelet therapy (SAPT) with aspirin or a P2Y12 inhibitor against L-DAPT (6-12 months) after PCI with current generation DES. Primary end-points of interest were major bleeding and stent thrombosis (ST) at 1 year. Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. RESULTS Eleven RCTs (n = 48,946) were included in the primary analysis. Major bleeding was significantly lower with S-DAPT (n = 24,424) (odd ratio [OR 0.65; 95% confidence interval, CI 0.52-0.80]) compared with L-DAPT (n = 24,486). There were no differences in ST between the two groups [OR 1.26; 95% CI 0.97-1.63]. There were no significant differences in risks of all-cause death, cardiovascular death or myocardial infarction between S-DAPT and L-DAPT groups. In a subgroup analysis, there was borderline significantly higher ST with 1 month S-DAPT [1.39; 1.0-1.92], but not with 3 months S-DAPT [1.07; 0.70-1.64], when compared to L-DAPT. Finally, there were no significant treatment interactions observed when trials using SAPT with aspirin were compared with those using P2Y12 inhibitor monotherapy. CONCLUSION Among patients undergoing current generation DES implantation, S-DAPT for 1-3 months reduces major bleeding without an increase in ischemic events compared with L-DAPT. Three months S-DAPT might provide a better risk-benefit profile based on current analysis. Further study is needed to define the SAPT of choice after 1-3 months DAPT.
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Affiliation(s)
- Amit Rout
- Division of Cardiology, University of Louisville, Kentucky, USA
| | - Abhishek Sharma
- Division of Cardiology, Rutgers New Jersey Medical School, New Jersey, USA
| | - Sohail Ikram
- Division of Cardiology, University of Louisville, Kentucky, USA
| | - Aakash Garg
- Division of Cardiology, Ellis Hospital, New York, USA
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Kinlay S, Young MM, Sherrod R, Gagnon DR. Long-Term Outcomes and Duration of Dual Antiplatelet Therapy After Coronary Intervention With Second-Generation Drug-Eluting Stents: The Veterans Affairs Extended DAPT Study. J Am Heart Assoc 2023; 12:e027055. [PMID: 36645075 PMCID: PMC9939065 DOI: 10.1161/jaha.122.027055] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2022] [Accepted: 11/04/2022] [Indexed: 01/17/2023]
Abstract
Background Recent guidelines on dual antiplatelet therapy (DAPT) duration after percutaneous coronary intervention (PCI) balance the subsequent risks of major bleeding with ischemic events. Although generally favoring shorter DAPT duration with second-generation drug-eluting stents, the effects on long-term outcomes in the wider population are uncertain. Methods and Results We tracked all patients having PCI with second-generation drug-eluting stents in the Veterans Affairs Healthcare System between 2006 and 2016 for death, myocardial infarction, stroke, and major bleeding up to 13 years. We compared these outcomes with 4 DAPT durations of 1 to 5, 6 to 9, 10 to 12, and 13 to 18 months after the index PCI using hazard ratios (HRs) and 95% CIs from Cox proportional hazards models adjusted by inverse probability weighting. A total of 40 882 subjects with PCI were followed up for a median of 4.3 (25%-75%: 2.4-6.5) years. DAPT discontinuation was rare early after PCI (5.8% at 1-5 months and 6.3% at 6-9 months) but increased (19% and 44%) >9 months. The risk of cardiovascular and noncardiovascular death was higher (HR, 2.03-3.41) with DAPT discontinuation <9 months, likely reflecting premature cessation from factors related to early death. DAPT discontinuation after 9 months following PCI was associated with lower risks of death (HR, 0.93 [95% CI, 0.88-0.99]), cardiac death (HR, 0.79 [95% CI, 0.70-0.90]), myocardial infarction (HR, 0.75 [95% CI, 0.69-0.82]), and major bleeding (HR, 0.82 [95% CI, 0.74-0.91]). Results were similar with an index PCI for an acute coronary syndrome. Conclusions Stopping DAPT after 9 months is associated with lower long-term risks of adverse ischemic and bleeding events and supports recent guidelines of shorter duration DAPT after PCI with second-generation drug-eluting stents.
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Affiliation(s)
- Scott Kinlay
- Veterans Affairs Boston Healthcare SystemWest RoxburyMA
- Harvard Medical SchoolBostonMA
- Department of Biostatistics, Massachusetts Veterans Epidemiology Research & Information Center (MAVERIC)VA Boston Healthcare SystemBostonMA
- Brigham and Women’s HospitalBostonMA
- Boston University Medical SchoolBostonMA
| | - Melissa M. Young
- Veterans Affairs Boston Healthcare SystemWest RoxburyMA
- Department of Biostatistics, Massachusetts Veterans Epidemiology Research & Information Center (MAVERIC)VA Boston Healthcare SystemBostonMA
| | | | - David R. Gagnon
- Veterans Affairs Boston Healthcare SystemWest RoxburyMA
- Department of Biostatistics, Massachusetts Veterans Epidemiology Research & Information Center (MAVERIC)VA Boston Healthcare SystemBostonMA
- Boston University School of Public HealthBostonMA
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Siasos G, Tsigkou V, Bletsa E, Stampouloglou PK, Oikonomou E, Kalogeras K, Katsarou O, Pesiridis T, Vavuranakis M, Tousoulis D. Antithrombotic Treatment in Coronary Artery Disease. Curr Pharm Des 2023; 29:2764-2779. [PMID: 37644793 DOI: 10.2174/1381612829666230830105750] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2023] [Revised: 06/16/2023] [Accepted: 07/20/2023] [Indexed: 08/31/2023]
Abstract
Coronary artery disease exhibits growing mortality and morbidity worldwide despite the advances in pharmacotherapy and coronary intervention. Coronary artery disease is classified in the acute coronary syndromes and chronic coronary syndromes according to the most recent guidelines of the European Society of Cardiology. Antithrombotic treatment is the cornerstone of therapy in coronary artery disease due to the involvement of atherothrombosis in the pathophysiology of the disease. Administration of antiplatelet agents, anticoagulants and fibrinolytics reduce ischemic risk, which is amplified early post-acute coronary syndromes or post percutaneous coronary intervention; though, antithrombotic treatment increases the risk for bleeding. The balance between ischemic and bleeding risk is difficult to achieve and is affected by patient characteristics, procedural parameters, concomitant medications and pharmacologic characteristics of the antithrombotic agents. Several pharmacological strategies have been evaluated in patients with coronary artery disease, such as the effectiveness and safety of antithrombotic agents, optimal dual antiplatelet treatment schemes and duration, aspirin de-escalation strategies of dual antiplatelet regimens, dual inhibition pathway strategies as well as triple antithrombotic therapy. Future studies are needed in order to investigate the gaps in our knowledge, including special populations.
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Affiliation(s)
- Gerasimos Siasos
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
- Cardiovascular Division, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA
| | - Vasiliki Tsigkou
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Evanthia Bletsa
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Panagiota K Stampouloglou
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Evangelos Oikonomou
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Konstantinos Kalogeras
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Ourania Katsarou
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Theodoros Pesiridis
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Manolis Vavuranakis
- Department of Cardiology, School of Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Athens 11527, Greece
| | - Dimitris Tousoulis
- Department of Cardiology, School of Medicine, 'Hippokration' General Hospital, National and Kapodistrian University of Athens, Athens, Greece
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Mezier A, Motreff P, Clerc JM, Bar O, Deballon R, Demicheli T, Dechery T, Souteyrand G, Py A, Lhoest N, Lhermusier T, Honton B, Gommeaux A, Jeanneteau J, Deharo P, Benamer H, Cayla G, Koning R, Pereira B, Collet JP, Rangé G. Is the duration of dual antiplatelet therapy (DAPT) excessive in post-angioplasty in chronic coronary syndrome? Data from the France-PCI registry (2014-2019). Front Cardiovasc Med 2023; 10:1106503. [PMID: 37034332 PMCID: PMC10080068 DOI: 10.3389/fcvm.2023.1106503] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/23/2022] [Accepted: 03/06/2023] [Indexed: 04/11/2023] Open
Abstract
Background while the duration of dual antiplatelet therapy (DAPT) following coronary angioplasty for chronic coronary syndrome (CCS) recommended by the European Society of Cardiology has decreased over the last decade, little is known about the adherence to those guidelines in clinical practice in France. Aim To analyze the real duration of DAPT post coronary angioplasty in CCS, as well as the factors affecting this duration. Methods Between 2014 and 2019, 8.836 percutaneous coronary interventions for CCS from the France-PCI registry were evaluated, with 1 year follow up, after exclusion of patients receiving oral anticoagulants, procedures performed within one year of an acute coronary syndrome, and repeat angioplasty. Results Post-percutaneous coronary intervention (PCI) DAPT duration was > 12 months for 53.1% of patients treated for CCS; 30.5% had a DAPT between 7 and 12 months, and 16.4% a DAPT ≤ 6 months. Patients with L-DAPT (>12 months) were at higher ischemic risk [25.0% of DAPT score ≥2 vs. 18.8% DAPT score ≥2 in S&I-DAPT group (≤12 months)]. The most commonly used P2Y12 inhibitor was clopidogrel (82.2%). The prescription of ticagrelor increased over the period. Conclusions post-PCI DAPT duration in CCS was higher than international recommendations in the France PCI registry between 2014 and 2019. More than half of the angioplasty performed for CCS are followed by a DAPT > 12 months. Ischemic risk assessment influences the duration of DAPT. This risk is probably overestimated nowadays, leading to a prolongation of DAPT beyond the recommended durations, thus increasing the bleeding risk.
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Affiliation(s)
- A. Mezier
- Cardiology Department, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
- Correspondence: A. Mezier
| | - P. Motreff
- Cardiology Department, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
| | - J. M. Clerc
- Cardiology Department, Centre Hospitalier Universitaire de Tours, Tours, France
| | - O. Bar
- Cardiology Department, Nouvelle Clinique Tourangelle, Saint-Cyr-sur-Loire, France
| | - R. Deballon
- Cardiology Department, Clinique Oréliance, Orléans, France
| | - T. Demicheli
- Cardiology Department, Les Hôpitaux de Chartres, Chartres, France
| | - T. Dechery
- Cardiology Department, Centre Hospitalier Jacques Coeur, Bourges, France
| | - G. Souteyrand
- Cardiology Department, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
| | - A. Py
- Cardiology Department, Clinique de l’Europe, Amiens, France
| | - N. Lhoest
- Cardiology Departemnt, Clinique Rhéna, Strasbourg, France
| | - T. Lhermusier
- Cardiology Department, Centre Hospitalier Universitaire de Toulouse, Toulouse, France
| | - B. Honton
- Cardiology Department, Clinique Pasteur, Toulouse, France
| | - A. Gommeaux
- Cardiology Department, Hôpital Privé de Bois-Bernard, Bois-Bernard, France
| | - J. Jeanneteau
- Cardiology Department, Clinique Saint Joseph, Trelaze, France
| | - P. Deharo
- Cardiology Department, Centre Hospitalier Universitaire de la Timone, Marseille, France
| | - H. Benamer
- Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France
| | - G. Cayla
- Cardiology Department, Centre Hospitalier Universitaire de Nîmes, Nîmes, France
| | - R. Koning
- Cardiology Department, Clinique Saint Hilaire, Rouen, France
| | - B. Pereira
- Clinical Research and Innovation Direction, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
| | - J. P. Collet
- Cardiology Institute, Hôpital Pitié-Salpêtrière (Assistance Publique-Hôpitaux de Paris), Paris, France
| | - G. Rangé
- Cardiology Department, Les Hôpitaux de Chartres, Chartres, France
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Choi KH, Park YH, Song YB, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Oh JH, Chun WJ, Jang WJ, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Gwon HC, Hahn JY. Long-term Effects of P2Y12 Inhibitor Monotherapy After Percutaneous Coronary Intervention: 3-Year Follow-up of the SMART-CHOICE Randomized Clinical Trial. JAMA Cardiol 2022; 7:1100-1108. [PMID: 36169938 PMCID: PMC9520445 DOI: 10.1001/jamacardio.2022.3203] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/28/2022] [Accepted: 07/29/2022] [Indexed: 12/15/2022]
Abstract
Importance Although P2Y12 inhibitor monotherapy after a minimum period of dual antiplatelet therapy (DAPT) is a well-known way to reduce the risk of bleeding after percutaneous coronary intervention (PCI), data comparing long-term clinical outcomes between P2Y12 inhibitor monotherapy and extended DAPT in patients undergoing PCI have been unavailable. Objective To identify the long-term safety and efficacy of P2Y12 inhibitor monotherapy following 3 months of DAPT after PCI. Design, Setting, and Participants The Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) trial was an open-label, noninferiority, randomized clinical trial, enrolling patients who underwent PCI with drug-eluting stent at 33 hospitals in Korea from March 2014 through July 2017. Clinical follow-up was extended to 3 years and completed in August 2020. Interventions Patients were randomly assigned to either P2Y12 inhibitor monotherapy after 3 months of DAPT or DAPT for 12 months or longer. Main Outcomes and Measures The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 3 years. The secondary end points included the components of the primary end point, bleeding (defined as Bleeding Academic Research Consortium [BARC] types 2-5), and major bleeding (BARC types 3-5). Results In total, 2993 patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (1495 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1087 [72.7%] male) or prolonged DAPT (1498 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1111 [74.2%] male) after PCI. At 3 years, the primary end point occurred in 87 individuals (6.3%) in the P2Y12 inhibitor monotherapy group and 83 (6.1%) in the prolonged DAPT group (hazard ratio [HR], 1.06 [95% CI, 0.79-1.44]; P = .69). P2Y12 inhibitor monotherapy significantly reduced the risk of bleeding (BARC types 2-5: 112 [3.2%] vs 44 [8.2%]; HR, 0.39 [95% CI, 0.28-0.55]; P < .001) and major bleeding (BARC types 3-5; 17 [1.2%] vs 31 [2.4%]; HR, 0.56 [95% CI, 0.31-0.99]; P = .048), compared with prolonged DAPT. The landmark analyses between 3 months and 3 years and per-protocol analyses showed consistent results. Conclusions and Relevance Among patients who underwent PCI and completed 3-month DAPT, P2Y12 inhibitor monotherapy was associated with a lower risk of clinically relevant major bleeding than prolonged DAPT. Although the 3-year risk of ischemic cardiovascular events was comparable between the 2 groups, this result should be interpreted with caution owing to the limited number of events and sample size. Trial Registration ClinicalTrials.gov Identifier: NCT02079194.
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Affiliation(s)
- Ki Hong Choi
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Yong Hwan Park
- Department of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
| | - Young Bin Song
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Taek Kyu Park
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Joo Myung Lee
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jeong Hoon Yang
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jin-Ho Choi
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Seung-Hyuk Choi
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Ju-Hyeon Oh
- Department of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
| | - Woo Jung Chun
- Department of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
| | - Woo Jin Jang
- Department of Cardiology, Ewha Woman's University Seoul Hospital, Ewha Woman's University School of Medicine, Seoul, Korea
| | - Eul-Soon Im
- Division of Cardiology, Dongsuwon General Hospital, Suwon, Korea
| | - Jin-Ok Jeong
- Chungnam National University Hospital, Daejeon, Korea
| | - Byung Ryul Cho
- Division of Cardiology, Kangwon National University Hospital, Chuncheon, Korea
| | - Seok Kyu Oh
- Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Korea
| | - Kyeong Ho Yun
- Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Korea
| | - Deok-Kyu Cho
- Division of Cardiology, Department of Internal Medicine, Yongin Severance Hospital, Yongin, Korea
| | - Jong-Young Lee
- Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Young-Youp Koh
- Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea
| | - Jang-Whan Bae
- Department of Internal Medicine, College of Medicine, Chungbuk National University Hospital, Cheongju, Korea
| | | | | | - Hyuck Jun Yoon
- Keimyung University Dongsan Medical Center, Daegu, Korea
| | | | | | | | | | - Hyeon-Cheol Gwon
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Joo-Yong Hahn
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
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Luo L, Wang S, Tang K, Yang X, Wu J, Wang D, Xu L, Feng T, Li D, Ran J, Li D, Zhang L, Zhao D. Efficacy and safety of dual antiplatelet therapy after percutaneous coronary drug-eluting stenting: A network meta-analysis. Medicine (Baltimore) 2022; 101:e31158. [PMID: 36281144 PMCID: PMC9592305 DOI: 10.1097/md.0000000000031158] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/12/2022] [Accepted: 09/14/2022] [Indexed: 11/06/2022] Open
Abstract
BACKGROUND To evaluate the efficacy and safety of dual antiplatelet regimens after coronary drug-eluting stenting by network meta-analysis (NMA). METHODS PubMed, The Cochrane Library, Embase, and Web of Science databases were electronically searched to collect randomized controlled trials (RCTs) of the comparison of different dual antiplatelet regimens after coronary drug-eluting stenting from inception to September 1st, 2021. Two reviewers independently screened literature, extracted data, and assessed the risk bias of included studies. Stata 16.0 software was used for NMA. RESULTS A total of 27 RCTs involving 79,880 patients were included. The results of NMA: in terms of myocardial infarction (MI), other 3 interventions were higher than the long-term dual antiplatelet therapy (L-DAPT) (the standard dual antiplatelet therapy [Std-DAPT] [odds ratio [OR] = 1.82, 95%confidence interval [CI]: 1.49-2.21), the aspirin monotherapy after short-term dual antiplatelet therapy (S-DAPT + As) (OR = 2.06, 95%CI: 1.57-2.70), the P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy (S-DAPT + P2Y12) (OR = 1.71, 95%CI: 1.29-2.28)]. In terms of stent thrombosis, other 3 interventions were higher than L-DAPT [Std-DAPT (OR = 2.18, 95%CI: 1.45-3.28), S-DAPT + As (OR = 2.32, 95%CI: 1.52-3.54), S-DAPT + P2Y12 (OR = 2.31, 95%CI: 1.22-4.36)]. There was no statistically significant difference among the 4 interventions in prevention of stroke and all-cause mortality (P > .05). In terms of cardiovascular and cerebrovascular adverse events, other 3 interventions were higher than L-DAPT (Std-DAPT [OR = 1.28, 95%CI: 1.12-1.45], S-DAPT + As [OR = 1.27, 95%CI: 1.09-1.48], S-DAPT + P2Y12 [OR = 1.24, 95%CI: 1.01-1.52]). In terms of safety, bleeding rate of other 3 interventions were lower than L-DAPT (Std-DAPT [OR = 0.67, 95%CI: 0.52-0.85], S-DAPT + As [OR = 0.51, 95%CI: 0.39-0.66], S-DAPT + P2Y12 [OR = 0.36, 95%CI: 0.26-0.49]). Two interventions were lower than L-DAPT (S-DAPT + As [OR = 0.77, 95%CI: 0.65-0.90], S-DAPT + P2Y12 [OR = 0.54, 95%CI: 0.44-0.66]). S-DAPT + As was higher than L-DAPT (OR = 1.42, 95%CI: 1.10-1.83). CONCLUSIONS S-DAPT + P2Y12 has the lowest bleeding risk, while L-DAPT has the highest bleeding risk. In the outcome of MI, stent thrombosis, and cardiovascular and cerebrovascular adverse events, L-DAPT has the best efficacy. In the outcome of stroke and all-cause mortality, the 4 interventions were equally effective.
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Affiliation(s)
- Lin Luo
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Shenglin Wang
- Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
| | - Kai Tang
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Xu Yang
- Department of Ophthalmolgy, Sichuan Academy of Medical Sciences, Sichuan Provincial People’s Hospital, Chengdu, China
| | - Jianli Wu
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Dan Wang
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Liqiong Xu
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Tao Feng
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Dejin Li
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Jiuju Ran
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Debo Li
- Department of Neurology, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Li Zhang
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
| | - Dan Zhao
- Department of Cardiovascular, The First People’s Hospital of Shuangliu District, Chengdu, China
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Farag M, Jeyalan V, Ferreiro JL, Jeong YH, Geisler T, Gorog DA. Reduction or de-escalation of dual antiplatelet therapy intensity or duration in patients with acute coronary syndromes undergoing percutaneous coronary intervention: A mini-review. Front Cardiovasc Med 2022; 9:1018649. [PMID: 36337887 PMCID: PMC9630649 DOI: 10.3389/fcvm.2022.1018649] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2022] [Accepted: 09/30/2022] [Indexed: 11/15/2022] Open
Abstract
Current guidelines for patients with acute coronary syndrome (ACS) recommend dual antiplatelet therapy (DAPT) for 12 months. Since bleeding is the main Achilles' heel of DAPT, in recent years several randomized controlled trials have evaluated the safety and efficacy of de-escalation of DAPT with respect to ischaemic and bleeding endpoints. These trials can be broadly divided into studies evaluating a shorter duration of DAPT, and those studies in which DAPT that includes a potent P2Y12 inhibitor, such as prasugrel or ticagrelor, is compared to less intense DAPT, mainly clopidogrel or reduced-dose prasugrel. We sought to evaluate the studies assessing de-escalation of DAPT in patients with ACS undergoing PCI. We review the studies evaluating the strategies of de-escalation of DAPT intensity and those evaluating a strategy of de-escalation of DAPT duration in ACS patients undergoing PCI. We summarize the limitations of studies to date, gaps in evidence and make recommendations for future studies.
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Affiliation(s)
- Mohamed Farag
- Department of Cardiology, East and North Hertfordshire NHS Trust, Stevenage, United Kingdom
- Department of Clinical, Pharmaceutical and Biological Science, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom
- *Correspondence: Mohamed Farag
| | - Visvesh Jeyalan
- Department of Cardiothoracic, Freeman Hospital, Newcastle upon Tyne, United Kingdom
| | - Jose Luis Ferreiro
- Department of Cardiology, CIBERCV, Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Spain
- Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain
| | - Young-Hoon Jeong
- CAU Thrombosis and Biomarker Center, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si, South Korea
- Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea
| | - Tobias Geisler
- Department of Cardiology and Angiology, University Hospital, Eberhard-Karls-University Tuebingen, Tübingen, Germany
| | - Diana A. Gorog
- Department of Cardiology, East and North Hertfordshire NHS Trust, Stevenage, United Kingdom
- Department of Clinical, Pharmaceutical and Biological Science, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom
- Imperial College, National Heart and Lung Institute, London, United Kingdom
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Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristić A, Sade LE, Schirmer H, Schüpke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J 2022; 43:3826-3924. [PMID: 36017553 DOI: 10.1093/eurheartj/ehac270] [Citation(s) in RCA: 434] [Impact Index Per Article: 144.7] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022] Open
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Ullah W, Zahid S, Sandhyavenu H, Faisaluddin M, Khalil F, Pasha AK, Alraies MC, Cuisset T, Rao SV, Sabouret P, Savage MP, Fischman DL. Extended, standard, or De-escalation antiplatelet therapy for patients with coronary artery disease undergoing percutaneous coronary intervention? A trial-sequential, bivariate, influential, and network meta-analysis. EUROPEAN HEART JOURNAL. CARDIOVASCULAR PHARMACOTHERAPY 2022; 8:717-727. [PMID: 35325105 DOI: 10.1093/ehjcvp/pvac020] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/03/2022] [Revised: 03/02/2022] [Accepted: 03/16/2022] [Indexed: 06/14/2023]
Abstract
AIMS The relative safety and efficacy of de-escalation, extended duration (ED) (>12-months), and standard dual antiplatelet therapy for 12-months (DAPT-12) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) remains controversial. METHODS AND RESULTS Online databases were queried to identify relevant randomized control trials (RCTs). ED-DAPT, high-potency (HP) DAPT, shorter duration (SD) DAPT, and low-dose (LD) DAPT were compared with DAPT-12. A trial sequential, bivariate, influential, and frequentist network meta-analysis (NMA) was performed to determine the pooled estimates. A total of 30 RCTs comprising 81 208 (40 839 experimental, 40 369 control arm) patients with CAD were included in the quantitative analysis. On NMA, compared with DAPT-12, all types of de-escalation, HP-DAPT-12, and ED-DAPT strategies had a statistically non-significant difference in the incidence of MACE at a median follow-up of 1-year. Similarly, there was no significant difference in the incidence of stroke, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and all-cause mortality between DAPT-12 and all other strategies. The network estimates showed a significantly lower incidence of major bleeding with DAPT for 3-months followed by P2Y12-inhibitor monotherapy (RR 0.62, 95% CI 0.45-0.84), while a higher risk of bleeding with HP-DAPT for 12 months (RR 1.55, 95% CI 1.16-2.06). The net clinical benefit and rankograms also favoured DAPT-3 (P2Y12) and discouraged the use of HP-DAPT-12 and ED-DAPT. A subgroup analysis of 19 RCTs restricted to patients who presented with acute coronary syndrome (ACS) mirrored the findings of pooled analysis. A sensitivity analysis revealed no influence of any individual study or individual strategy on net ischemic estimates. The trial sequential analysis (TSA) illustrated a consistently non-significant difference at the interim analysis of trials, reaching the futility area for MACE, while the cumulative Z-values line surpassed the monitoring boundary as well as the required information size for major bleeding favouring de-escalation strategy. CONCLUSION DAPT for three months followed by ticagrelor-only and use of aspirin + clopidogrel after a short period of high potency DAPT appears to be a safe strategy for treating post-PCI patients. However, given the methodological limitations and inclusion of a small number of trials in novel de-escalation strategies, these findings need validation by future large scale RCTs.
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Affiliation(s)
- Waqas Ullah
- Division of Cardiology, Thomas Jefferson University Hospitals, 111 S 11th Street, Philadelphia, PA 19107, USA
| | - Salman Zahid
- Rochester General Hospital, 1425 Portland Ave, Rochester, NY 14621, USA
| | | | | | - Fouad Khalil
- Sanford School of Medicine, University of South Dakota, 1400 West 22nd Street, Sioux Falls, SD 57105, USA
| | - Ahmad K Pasha
- UHS Wilson Hospital, 33-57 Harrison Street, Johnson City, NY 13790, USA
| | - M Chadi Alraies
- Detroit Medical Center, Heart Hospital, 311 Mack Ave, Detroit, MI 48201, USA
| | - Thomas Cuisset
- Aix-Marseille University, 58 Boulevard Charles Livon, 13007 Marseille, France
| | - Sunil V Rao
- The Duke Clinical Research Institute, Durham, NC, USA
| | - Pierre Sabouret
- Collège National des Cardiologues Français, 13 Rue Niépce, 75014 Paris, France
| | - Michael P Savage
- Division of Cardiology, Thomas Jefferson University Hospitals, 111 S 11th Street, Philadelphia, PA 19107, USA
| | - David L Fischman
- Division of Cardiology, Thomas Jefferson University Hospitals, 111 S 11th Street, Philadelphia, PA 19107, USA
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Clifford CR, Boudreau R, Visintini S, Orr N, Fu AYN, Malhotra N, Barry Q, So DYF. The association of PRECISE-DAPT score with ischaemic outcomes in patients taking dual antiplatelet therapy following percutaneous coronary intervention: a meta-analysis. EUROPEAN HEART JOURNAL. CARDIOVASCULAR PHARMACOTHERAPY 2022; 8:511-518. [PMID: 34849686 DOI: 10.1093/ehjcvp/pvab080] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/05/2021] [Revised: 11/09/2021] [Accepted: 11/18/2021] [Indexed: 06/13/2023]
Abstract
AIMS The PRECISE-DAPT (Predicting Bleeding Complication in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) score identifies patients at high risk of bleeding complications following percutaneous coronary intervention (PCI). International guidelines recommend the PRECISE-DAPT score to identify patients at high risk for bleeding, who may benefit from shortened dual antiplatelet therapy. The association of the PRECISE-DAPT score with ischaemic outcomes remains unclear. We performed a meta-analysis investigating the association between a high PRECISE-DAPT score and ischaemic outcomes. METHODS AND RESULTS A comprehensive literature search was conducted on articles published between 11 March 2017 and 5 June 2021. Two reviewers independently screened articles for inclusion using pre-defined criteria. The outcome measures extracted included composite ischaemic events, major bleeding events, and all-cause mortality. A random effects model was applied to obtain combined risk estimates for outcomes. From 12 included studies, there were 39 459 patients with PRECISE-DAPT <25 and 14 761 patients with PRECISE-DAPT ≥25. PRECISE-DAPT score ≥25 was associated with increased risk of composite ischaemic events [odds ratio (OR) 2.16; 95% confidence interval (CI) 1.77-2.65], myocardial infarction (OR 2.06; 95% CI 1.38-3.08), and ischaemic stroke (OR 2.90; 95% CI 1.76-4.78). Patients with a PRECISE-DAPT score ≥25 had increased risk of major bleeding (OR 3.62; 95% CI 2.62-4.99). Patients with a PRECISE-DAPT score ≥25 had higher risk of all-cause mortality (OR 5.83; 95% CI 5.37-6.33). CONCLUSION Patients with a PRECISE-DAPT score ≥25 are at increased risk for ischaemic events, bleeding, and all-cause mortality. Prospective evaluation of a PRECISE-DAPT guided approach to antiplatelet therapy is required to demonstrate benefit in this high-risk population.
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Affiliation(s)
- Cole R Clifford
- Division of Cardiology, University of Ottawa Heart Institute, Room H3408, 40 Ruskin Street, Ottawa, Ontario K1Y 4W7, Canada
| | - Rene Boudreau
- Division of Cardiology, University of Ottawa Heart Institute, Room H3408, 40 Ruskin Street, Ottawa, Ontario K1Y 4W7, Canada
| | - Sarah Visintini
- Berkamn Library, University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada
| | - Nathan Orr
- Berkamn Library, University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada
| | - Angel Y N Fu
- Division of Cardiology, University of Ottawa Heart Institute, Room H3408, 40 Ruskin Street, Ottawa, Ontario K1Y 4W7, Canada
| | - Nikita Malhotra
- Division of Cardiology, University of Ottawa Heart Institute, Room H3408, 40 Ruskin Street, Ottawa, Ontario K1Y 4W7, Canada
| | - Quinton Barry
- Division of Cardiology, University of Ottawa Heart Institute, Room H3408, 40 Ruskin Street, Ottawa, Ontario K1Y 4W7, Canada
| | - Derek Y F So
- Division of Cardiology, University of Ottawa Heart Institute, Room H3408, 40 Ruskin Street, Ottawa, Ontario K1Y 4W7, Canada
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Garg A, Rout A, Farhan S, Waxman S, Giustino G, Tayal R, Abbott JD, Huber K, Angiolillo DJ, Rao SV. Dual antiplatelet therapy duration after percutaneous coronary intervention using drug eluting stents in high bleeding risk patients: A systematic review and meta-analysis. Am Heart J 2022; 250:1-10. [PMID: 35436504 DOI: 10.1016/j.ahj.2022.04.004] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/28/2021] [Revised: 03/11/2022] [Accepted: 04/12/2022] [Indexed: 06/14/2023]
Abstract
BACKGROUND Optimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR. METHODS We searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. RESULTS Six randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]. CONCLUSIONS Among HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT.
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Affiliation(s)
- Aakash Garg
- Division of Cardiology, Brown University, Providence, RI.
| | - Amit Rout
- Division of Cardiology, University of Louisville, Louisville, KY
| | - Serdar Farhan
- Division of Cardiology, Icahn school of Medicine at Mount Sinai, New York, NY
| | - Sergio Waxman
- Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ
| | - Gennaro Giustino
- Division of Cardiology, University of Louisville, Louisville, KY
| | - Raj Tayal
- Division of Cardiology, Valley Hospital, Ridgewood, NJ
| | | | - Kurt Huber
- Division of Cardiology, Medical University of Vienna, Vienna, Austria
| | - Dominick J Angiolillo
- Division of Cardiology, University of Florida College of Medicine-Jacksonville, Jacksonville, FL
| | - Sunil V Rao
- Division of Cardiology, Duke Clinical Research Institute, Durham, NC
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Zhong PY, Shang YS, Bai N, Ma Y, Niu Y, Wang ZL. Dual Antiplatelet Therapy After Drug-Eluting Stents Implantation in East Asians: A Network Meta-Analysis of Randomized Controlled Trials. J Cardiovasc Pharmacol 2022; 80:216-225. [PMID: 35561287 DOI: 10.1097/fjc.0000000000001288] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/10/2022] [Accepted: 03/30/2022] [Indexed: 12/23/2022]
Abstract
ABSTRACT Dual antiplatelet therapy (DAPT) is essential to prevent the risk of ischemia events, but it is difficult to avoid concurrent bleeding events. East Asians are associated with a higher tendency of bleeding than Caucasians, which may affect the DAPT duration. Therefore, this network meta-analysis to explore optimum DAPT duration for East Asians. The related randomized controlled trials that compared the different DAPT duration in East Asian patients were included by searching PubMed, EMBASE, and Cochrane Library database. The outcomes included myocardial infarction, stent thrombosis, all-cause death, stroke, and major bleeding. In addition, net adverse cardiac and cardiovascular events was defined as a composite outcome in this study. We calculated the odds ratio (OR) and 95% confidence intervals for end point events by the fixed effects model in the Bayesian's network frame. We included a total of 12 randomized controlled trials with 30,640 patients. Compared with 12-month DAPT, 1- to 3-month DAPT is effective in myocardial infarction (OR 0.72, 0.46-1.08), stents thrombosis (OR 1.27, 0.59-2.84), all-cause death (OR 0.91, 0.65-1.28), and stroke (OR 0.89, 0.57-1.39). The 1- to 3-month DAPT was associated with a lower risk of major bleeding compared with 12-month DAPT (OR 0.55, 0.4-0.76), 6-month DAPT (OR 0.54, 0.31-0.94), and >12-month DAPT (OR 0.43, 0.28-0.65). In addition, more than 12 months of DAPT did not reduce the incidence of myocardial infarction (OR 0.75, 0.51-1.11) and increased the risk of major bleeding (OR 1.28, 0.88-1.87) compared with 12-month DAPT. The 1- to 3-month DAPT was more secure and effective than the other 3 DAPT strategies. Although East Asians have a higher risk of bleeding, more than 12 months of DAPT does not increase this incidence of major bleeding.
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Affiliation(s)
- Peng-Yu Zhong
- Department of Cardiology, Nanchong Central Hospital, Nanchong, China
| | - Yao-Sheng Shang
- The First Clinical Medical College of Lanzhou University, Lanzhou, China; and
| | - Nan Bai
- The First Clinical Medical College of Lanzhou University, Lanzhou, China; and
| | - Ying Ma
- The First Clinical Medical College of Lanzhou University, Lanzhou, China; and
| | - Ying Niu
- The First Clinical Medical College of Lanzhou University, Lanzhou, China; and
| | - Zhi-Lu Wang
- Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China
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Mihatov N, Secemsky EA, Kereiakes DJ, Steg PG, Cutlip DE, Kirtane AJ, Mehran R, Zhao B, Song Y, Gibson CM, Yeh RW. Individualizing Dual Antiplatelet Therapy (DAPT) Duration Based on Bleeding Risk, Ischemic Risk, or Both: An Analysis From the DAPT Study. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2022; 41:105-112. [PMID: 35045941 DOI: 10.1016/j.carrev.2022.01.006] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2021] [Revised: 12/19/2021] [Accepted: 01/07/2022] [Indexed: 02/01/2023]
Abstract
BACKGROUND Guidelines recommend individualization of dual antiplatelet therapy (DAPT) duration. Whether to guide decisions based on bleeding risk, ischemic risk or a combination is not known. AIMS To compare a bleeding prediction model, an ischemic prediction model, and the DAPT score in guiding DAPT duration. METHODS 11,648 patients in the DAPT Study were categorized into higher and lower risk using a bleeding model, an ischemic model, and the DAPT score. Effect of 30 vs. 12 months of DAPT on bleeding events, ischemic events, and the combination (net-adverse clinical events [NACE]) was assessed. RESULTS Among patients stratified with the bleeding model, 30 vs. 12 months of DAPT resulted in similar ischemic and bleeding event rates. With the ischemic model, however, higher risk patients had a greater reduction in ischemic events with extended duration of DAPT (difference in risk differences [DRD]: -2.6%, 95% CI: -3.9 to -1.3%; p < 0.01), and a smaller increase in bleeding (DRD: -1.0%, 95% CI: -2.1-0.0%; p = 0.04). Similarly, high DAPT score patients had a greater reduction in ischemic events with extended DAPT duration (DRD: -2.4%, 95%: CI: -3.6 to -1.1%; p < 0.01) and a smaller increase in bleeding (DRD: -1.2%, 95%: CI: -2.2-0.0%; p = 0.02). Although NACE was similar for bleeding risk groups, NACE was significantly reduced with extended DAPT in the higher ischemic risk and high DAPT score groups. CONCLUSIONS In this low-bleeding risk population, stratifying patients based on predicted ischemic risk and the DAPT score best discerned benefit versus harm of extended DAPT duration on ischemic events, bleeding events, and NACE. CONDENSED ABSTRACT Duration of dual antiplatelet therapy (DAPT) should be guided by an individualized risk assessment. Bleeding risk tools have emerged to identify patients at high bleeding risk for whom truncated DAPT therapy may be safest. In a lower bleeding risk population, however, whether DAPT duration should be guided by bleeding risk, ischemic risk, or a combination is unknown. In this analysis, implementation of a score based on ischemic risk prediction and the DAPT score (a combination of ischemic and bleeding risk) best predicted ischemic events, bleeding events, and net-adverse clinical events (NACE).
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Affiliation(s)
- Nino Mihatov
- Division of Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, NY, United States of America; Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States of America
| | - Eric A Secemsky
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States of America
| | - Dean J Kereiakes
- The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, United States of America
| | - P Gabriel Steg
- Université de Paris, INSERM-1148 LVTS, F-75018 & AP-HP, Hôpital Bichat, F-75018 Paris, France
| | - Donald E Cutlip
- Division of Cardiology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States of America
| | - Ajay J Kirtane
- Division of Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, NY, United States of America; Cardiovascular Research Foundation, New York, NY, United States of America
| | - Roxana Mehran
- Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America
| | - Bokai Zhao
- Baim Institute for Clinical Research, Boston, MA, United States of America
| | - Yang Song
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States of America
| | - C Michael Gibson
- Division of Cardiology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States of America
| | - Robert W Yeh
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States of America.
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48
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The Optimal Strategy of Dual Antiplatelet Therapy after Percutaneous Coronary Intervention with Drug-Eluting Stent. J Clin Med 2022; 11:jcm11154465. [PMID: 35956082 PMCID: PMC9370028 DOI: 10.3390/jcm11154465] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2022] [Revised: 07/20/2022] [Accepted: 07/26/2022] [Indexed: 11/23/2022] Open
Abstract
Objective: To test the optimal strategy of dual antiplatelet therapy (DAPT) after implantation of drug-eluting stents (DESs) according to specific DAPT time and subsequent monotherapy. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, and Web of Science to identify randomized controlled trials (RCTs). Six DAPT strategies were compared: 1-month DAPT followed by P2Y12 inhibitor monotherapy, 3-month DAPT followed by P2Y12 inhibitor monotherapy, 3-month DAPT followed by aspirin monotherapy, 6-month DAPT followed by aspirin monotherapy, 12-month DAPT, and >12-month DAPT. Pooled odd ratios (ORs) with 95% credible intervals (CrIs) were calculated to summarize the effect of each strategy tested. Results: We identified 24 RCTs containing 81,405 patients. In comparison with 12-month DAPT, 3-month DAPT followed by P2Y12 inhibitor monotherapy reduced net clinical events (OR: 0.72; CrI: 0.55−0.94). Major bleeding (OR: 0.57; CrI: 0.34−1.00) was marginally decreased without impact on ischemic events (OR: 0.93; CrI: 0.68−1.29). Moreover, the benefits of 3-month DAPT (P2Y12 inhibitor) were consistent for male patients with acute coronary disease, young age, complex lesion, single-vessel disease, low body mass index, and without diabetes. Although >12-month DAPT was associated with a lower risk of myocardial infarction (OR: 0.67; CrI: 0.51−0.93), the risk of major bleeding (OR: 1.70; CrI: 1.10−2.70) was increased. Conclusion: Among patients treated with DESs, 3-month DAPT followed by P2Y12 inhibitor monotherapy may be the optimal antiplatelet strategy, while DAPT beyond 1 year reduces myocardial infarction at the expense of increased major bleeding.
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Park DY, An S, Kumar A, Malhotra S, Jolly N, Kaur A, Kattoor A, Doukky R, Kalra A, Vij A. Abbreviated versus Standard Duration of DAPT after PCI: A Systematic Review and Network Meta-analysis. Am J Cardiovasc Drugs 2022; 22:633-645. [PMID: 35781867 DOI: 10.1007/s40256-022-00541-w] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 06/02/2022] [Indexed: 11/28/2022]
Abstract
BACKGROUND Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) is typically continued for 6-12 months depending on clinical presentation. Recent studies have evaluated the safety of shorter durations of DAPT across stable and unstable coronary syndrome but are limited by smaller patient pools and varying indications. METHODS The present study performed a systematic review and network meta-analysis comparing abbreviated (1-3 months) with standard (6-12 months) duration of DAPT. Both conventional and frequentist network meta-analyses with a random-effects model were conducted. RESULTS Seventeen randomized controlled trials, nine of which included 1-3 months of DAPT, were selected. The risks of any bleeding (RR 0.68, 95% CI 0.54-0.85), major bleeding (RR 0.66, 95% CI 0.50-0.86), and net adverse clinical events (NACE) (RR 0.87, 95% CI 0.76-0.99) were lower with abbreviated (1-3 months) than standard-term (6-12 months) DAPT. No significant differences in the risk of myocardial infarction (RR 1.02, 95% CI 0.87-1.18), definite or probable stent thrombosis (RR 1.11, 95% CI 0.83-1.50), and major adverse cardiac events (MACE) (RR 0.96, 95% CI 0.86-1.06) were observed. Network meta-analysis demonstrated lower risk of any bleeding, major bleeding, and NACE with shorter durations of DAPT compared with 12 months. Risks of definite or probable stent thrombosis, myocardial infarction, and MACE were not significantly different. CONCLUSION The results support the growing body of evidence that abbreviated duration (1-3 months) of DAPT may be considered to reduce the risk of bleeding without any differences in myocardial infarction, stent thrombosis, or MACE.
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Affiliation(s)
- Dae Yong Park
- Department of Medicine, Cook County Health, Chicago, IL, USA
| | - Seokyung An
- Department of Biomedical Science, Seoul National University Graduate School, Seoul, Korea
| | - Ashish Kumar
- Department of Internal Medicine, Cleveland Clinic Akron General, Akron, OH, USA
| | - Saurabh Malhotra
- Division of Cardiology, Cook County Health, Chicago, IL, USA.,Division of Cardiology, Rush Medical College, Chicago, IL, USA
| | - Neeraj Jolly
- Division of Cardiology, Rush University Medical Center, Chicago, IL, USA
| | - Amandeep Kaur
- Department of Pathology, Feinberg School of Medicine, Northwestern University, Chicago, USA
| | - Ajoe Kattoor
- Division of Cardiology, Rush University Medical Center, Chicago, IL, USA
| | - Rami Doukky
- Division of Cardiology, Cook County Health, Chicago, IL, USA.,Division of Cardiology, Rush Medical College, Chicago, IL, USA
| | - Ankur Kalra
- Section of Invasive and Interventional Cardiology, Cleveland Clinic, Akron, OH, USA
| | - Aviral Vij
- Division of Cardiology, Cook County Health, Chicago, IL, USA. .,Division of Cardiology, Rush Medical College, Chicago, IL, USA.
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50
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Kurihara K, Kawamoto S, Kimura A, Tanaka A, Yabe K, Nomoto H, Osaka Y, Miyazaki T, Suzuki A, Ono Y, Otomo K, Sasano T. Five-Year Impacts of Antithrombotic Therapy Based on 10-Year Clinical Outcomes of Cypher™ Stent Implantation. Cardiol Ther 2022; 11:433-444. [PMID: 35729308 PMCID: PMC9381656 DOI: 10.1007/s40119-022-00267-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/07/2022] [Accepted: 05/31/2022] [Indexed: 11/29/2022] Open
Abstract
Introduction Few researchers have investigated the optimal long-term antithrombotic therapy regimen, especially after first-generation drug-eluting stent (DES) use. This study aimed to evaluate the impact of mid-term antithrombotic therapy on long-term outcomes in patients treated with the first sirolimus-eluting coronary stent (Cypher™). Methods Between 2004 and 2009, 1021 patients underwent Cypher™ implantation at our institute; among them, 567 patients had available data on antithrombotic therapy at year 5. We assessed patients’ antithrombotic therapy at year 5 post Cypher™ implantation and examined their association with adverse events from year 5 to year 10 post Cypher™ implantation. Results Patients with dual-antiplatelet therapy (DAPT) at year 5 had significantly lower risk of stent thrombosis (ST) than those with single-antiplatelet therapy (SAPT) (hazard ratio [HR] 0.24, p = 0.034). The HR of major bleeding in DAPT, compared to SAPT, was high, but the difference was not significant (HR 1.72, p = 0.26). Risk of major bleeding was significantly higher in patients on oral anticoagulants (OAC) than in those in other groups (OAC/SAPT; HR 5.31, p = 0.0048, OAC/DAPT; HR 3.08, p = 0.022), without significant reduction in the risk of cardiovascular events. Conclusions The incidence of ST after Cypher™ implantation in patients with DAPT at year 5 was significantly lower than that in SAPT. However, the risk of bleeding was higher with DAPT than with SAPT. Moreover, the risk of major bleeding was significantly higher in patients on anticoagulant therapy than in other patients. New options for the use of antithrombotic drugs after percutaneous coronary intervention warrant further studies on the optimal antithrombotic therapy for first-generation DES.
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Affiliation(s)
- Ken Kurihara
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan.
| | - Shiho Kawamoto
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Ayaka Kimura
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Akifumi Tanaka
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Kento Yabe
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Hidetsugu Nomoto
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Yuki Osaka
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Toru Miyazaki
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Asami Suzuki
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Yuichi Ono
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Kenichiro Otomo
- Ome Municipal General Hospital, 4-16-5 Higashiome, Ome, Tokyo, 198-0042, Japan
| | - Tetsuo Sasano
- Department of Cardiovascular Medicine, Tokyo Medical and Dental University, 1-5-45 Yushima Bunkyoku, Tokyo, 113-8519, Japan
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