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White HD, O'Brien SM, Boden WE, Fremes SE, Bangalore S, Reynolds HR, Stone GW, Ali ZA, Parakh N, Lopez-Sendon JL, Wang Y, Chen YQ, Mark DB, Chaitman BR, Spertus JA, Maron DJ, Hochman JS. Use of Coronary Artery Bypass Graft Surgery and Percutaneous Coronary Intervention and Associated Outcomes in the ISCHEMIA Trial. Am Heart J 2025:S0002-8703(25)00165-6. [PMID: 40404111 DOI: 10.1016/j.ahj.2025.05.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2025] [Accepted: 05/15/2025] [Indexed: 05/24/2025]
Abstract
BACKGROUND In the ISCHEMIA Trial, 5179 patients with stable coronary disease were randomized to initial invasive or conservative management. METHODS PCI was recommended with a SYNTAX score 0-22 (low) and CABG with a SYNTAX score ≥33 (high). Either could be recommended for intermediate scores. The composite primary outcome was cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. There were two cohorts in this analysis. The descriptive cohort included patients who underwent CABG or PCI within 180 days of randomization and had no primary outcome before revascularization. The comparative cohort excluded participants with prior CABG, single vessel disease, SYNTAX score ≥ 45, and without core laboratory assessment. We focused on the intermediate (23-32) SYNTAX comparative group for which either CABG or PCI could be recommended. RESULTS For 1935 patients in the descriptive cohort (485 CABG, 1450 PCI), the SYNTAX score was 27.3 ± 11.0 in the CABG group and 15.3 ± 8.6 in the PCI group, p<0.0001. Most patients with low SYNTAX scores underwent PCI (87.1%), while most with high SYNTAX scores underwent CABG (72.6%). For the 1203 patients (385 CABG, 818 PCI) in the entire comparative cohort, the adjusted 4-year primary event rate was 14.5% for CABG and 13.2% for PCI (difference 1.3%, 95% CI, -4.9% to 7.7%). For the 346 patients (163 CABG, 183 PCI) in the intermediate SYNTAX group, the adjusted 4-year primary event rate was 10.6% for CABG and 18.3% for PCI (difference -7.6%, 95% CI, -16.1% to 0.9%). CONCLUSIONS Selection of revascularization method resulted in more PCI in the low SYNTAX group and more CABG in the high SYNTAX group. There was no statistical evidence of a difference between PCI and CABG in the intermediate SYNTAX group but the CIs are broad, reflecting uncertainty. CLINICAL TRIALS GOV IDENTIFIER NCT01471522; https://clinicaltrials.gov/ct2/show/NCT01471522.
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Affiliation(s)
- Harvey D White
- Health New Zealand - Whatu Ora -, Te Toka Tumai, Green Lane Cardiovascular Service, Auckland City Hospital, Auckland 1142, New Zealand.
| | - Sean M O'Brien
- Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
| | - William E Boden
- VA New England Healthcare System, Boston University School of Medicine, Boston, MA, USA.
| | - Stephen E Fremes
- University of Toronto, Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, ON Canada.
| | - Sripal Bangalore
- NYU Grossman School of Medicine, NYU Langone Health, Department of Medicine, New York, NY, USA.
| | - Harmony R Reynolds
- NYU Grossman School of Medicine, NYU Langone Health, Department of Medicine, New York, NY, USA.
| | - Gregg W Stone
- Icahn School of Medicine at Mount Sinai, New York, NY, USA.
| | - Ziad A Ali
- Cardiovascular Research Foundation, New York, NY, USA; Columbia University Medical Center/New York-Presbyterian Hospital, New York, NY, USA; St Francis Hospital, Roslyn, NY, USA.
| | - Neeraj Parakh
- All India Institute of Medical Sciences, New Delhi, India.
| | | | - Yixin Wang
- Stanford Prevention Research Center, Stanford, CA.
| | | | - Daniel B Mark
- Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Duke University, Durham, NC, USA.
| | - Bernard R Chaitman
- Saint Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis, MO.
| | - John A Spertus
- University of Missouri - Kansas City's Healthcare Institute for Innovations in Quality and Saint; Luke's Mid America Heart Institute, Kansas City, MO, USA.
| | - David J Maron
- Stanford Prevention Research Center, Stanford, CA; Department of Medicine, Stanford University, Stanford, CA, USA.
| | - Judith S Hochman
- NYU Grossman School of Medicine, NYU Langone Health, Department of Medicine, New York, NY, USA.
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2
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Chiba Y, Imagawa S, Takahashi Y, Kubo K, Otsuka K, Shimazu K, Anzai T, Yonezawa K, Kato M, Anzai T. Frequent Gastrointestinal Cancer Complications in Japanese Patients with Acute or Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention. J Clin Med 2025; 14:1807. [PMID: 40142615 PMCID: PMC11943319 DOI: 10.3390/jcm14061807] [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: 02/05/2025] [Revised: 02/28/2025] [Accepted: 03/06/2025] [Indexed: 03/28/2025] Open
Abstract
Background/Objective: Gastrointestinal bleeding is a major complication of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI). Malignancy may be detected due to gastrointestinal bleeding, necessitating critical decisions regarding treatment selection and influencing patient prognosis. Methods: This single-center, retrospective, observational study included 501 Japanese patients who underwent initial PCI between January 2019 and January 2023. Of these patients, 393 who underwent perioperative upper and lower gastrointestinal endoscopy were evaluated for the presence of gastrointestinal malignancy. Results: Of the total patients, 36% presented with acute coronary syndrome (ACS). Gastrointestinal malignancies were identified in 30 patients (8%), including 18 cases of colorectal cancer and eight cases of gastric cancer. No difference in the frequency of malignancies was observed between patients with ACS and chronic coronary syndrome (CCS) (p = 0.7398). Malignancies were significantly more common in patients with positive fecal immunochemical testing (FIT) (p < 0.0001); however, FIT did not detect all malignancies. The 1500-day survival rate for patients with gastrointestinal malignancies was 64%, with no difference in overall survival between treatment modalities. Conclusions: A considerable proportion of Japanese patients undergoing PCI had gastrointestinal malignancies, regardless of whether they had ACS or CCS, and their prognosis was poor. Gastrointestinal endoscopic evaluation in the perioperative period of PCI could detect malignancy without complications and might lead to appropriate cancer treatment.
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Affiliation(s)
- Yasuyuki Chiba
- Division of Cardiology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (S.I.); (Y.T.); (K.O.); (K.S.); (T.A.); (K.Y.)
| | - Shogo Imagawa
- Division of Cardiology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (S.I.); (Y.T.); (K.O.); (K.S.); (T.A.); (K.Y.)
| | - Yuki Takahashi
- Division of Cardiology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (S.I.); (Y.T.); (K.O.); (K.S.); (T.A.); (K.Y.)
| | - Kimitoshi Kubo
- Division of Gastroenterology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (K.K.); (M.K.)
| | - Kenta Otsuka
- Division of Cardiology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (S.I.); (Y.T.); (K.O.); (K.S.); (T.A.); (K.Y.)
| | - Kyo Shimazu
- Division of Cardiology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (S.I.); (Y.T.); (K.O.); (K.S.); (T.A.); (K.Y.)
| | - Teisuke Anzai
- Division of Cardiology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (S.I.); (Y.T.); (K.O.); (K.S.); (T.A.); (K.Y.)
| | - Kazuya Yonezawa
- Division of Cardiology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (S.I.); (Y.T.); (K.O.); (K.S.); (T.A.); (K.Y.)
| | - Mototsugu Kato
- Division of Gastroenterology, National Hospital Organization Hakodate Medical Center, Hakodate 041-8512, Japan; (K.K.); (M.K.)
- Department of Gastroenterology, Public Interest Foundation Hokkaido Cancer Society, Sapporo 065-0026, Japan
| | - Toshihisa Anzai
- Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, Japan;
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3
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Thompson A, Fleischmann KE, Smilowitz NR, de Las Fuentes L, Mukherjee D, Aggarwal NR, Ahmad FS, Allen RB, Altin SE, Auerbach A, Berger JS, Chow B, Dakik HA, Eisenstein EL, Gerhard-Herman M, Ghadimi K, Kachulis B, Leclerc J, Lee CS, Macaulay TE, Mates G, Merli GJ, Parwani P, Poole JE, Rich MW, Ruetzler K, Stain SC, Sweitzer B, Talbot AW, Vallabhajosyula S, Whittle J, Williams KA. 2024 AHA/ACC/ACS/ASNC/HRS/SCA/SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2024; 150:e351-e442. [PMID: 39316661 DOI: 10.1161/cir.0000000000001285] [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: 09/26/2024]
Abstract
AIM The "2024 AHA/ACC/ACS/ASNC/HRS/SCA/SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery" provides recommendations to guide clinicians in the perioperative cardiovascular evaluation and management of adult patients undergoing noncardiac surgery. METHODS A comprehensive literature search was conducted from August 2022 to March 2023 to identify clinical studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. STRUCTURE Recommendations from the "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" have been updated with new evidence consolidated to guide clinicians; clinicians should be advised this guideline supersedes the previously published 2014 guideline. In addition, evidence-based management strategies, including pharmacological therapies, perioperative monitoring, and devices, for cardiovascular disease and associated medical conditions, have been developed.
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Affiliation(s)
| | | | | | - Lisa de Las Fuentes
- Former ACC/AHA Joint Committee on Clinical Practice Guidelines member; current member during the writing effort
| | | | | | | | | | | | | | | | - Benjamin Chow
- Society of Cardiovascular Computed Tomography representative
| | | | | | | | | | | | | | | | | | | | | | - Purvi Parwani
- Society for Cardiovascular Magnetic Resonance representative
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4
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Thompson A, Fleischmann KE, Smilowitz NR, de Las Fuentes L, Mukherjee D, Aggarwal NR, Ahmad FS, Allen RB, Altin SE, Auerbach A, Berger JS, Chow B, Dakik HA, Eisenstein EL, Gerhard-Herman M, Ghadimi K, Kachulis B, Leclerc J, Lee CS, Macaulay TE, Mates G, Merli GJ, Parwani P, Poole JE, Rich MW, Ruetzler K, Stain SC, Sweitzer B, Talbot AW, Vallabhajosyula S, Whittle J, Williams KA. 2024 AHA/ACC/ACS/ASNC/HRS/SCA/SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2024; 84:1869-1969. [PMID: 39320289 DOI: 10.1016/j.jacc.2024.06.013] [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: 09/26/2024]
Abstract
AIM The "2024 AHA/ACC/ACS/ASNC/HRS/SCA/SCCT/SCMR/SVM Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery" provides recommendations to guide clinicians in the perioperative cardiovascular evaluation and management of adult patients undergoing noncardiac surgery. METHODS A comprehensive literature search was conducted from August 2022 to March 2023 to identify clinical studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. STRUCTURE Recommendations from the "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" have been updated with new evidence consolidated to guide clinicians; clinicians should be advised this guideline supersedes the previously published 2014 guideline. In addition, evidence-based management strategies, including pharmacological therapies, perioperative monitoring, and devices, for cardiovascular disease and associated medical conditions, have been developed.
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Fukase T, Doi S, Dohi T, Koike T, Nishio R, Yasuda H, Takeuchi M, Takahashi N, Chikata Y, Endo H, Nishiyama H, Okai I, Iwata H, Okazaki S, Daida H, Suwa S, Minamino T, Miyauchi K. Impact of Low-Dose Prasugrel on Platelet Reactivity in Chronic Phase of Post-Percutaneous Coronary Intervention (CHAPERON): a Prospective Cohort Study. Cardiovasc Drugs Ther 2024; 38:947-957. [PMID: 37097381 DOI: 10.1007/s10557-023-07454-z] [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: 04/18/2023] [Indexed: 04/26/2023]
Abstract
PURPOSE Asians often face the problems of clopidogrel resistance and East Asian paradox. This study aimed to evaluate the effects of P2Y12 inhibitors, including low-dose prasugrel 2.5 mg, on the P2Y12 reaction unit (PRU) in the chronic phase after percutaneous coronary intervention (PCI). METHODS A total of 348 patients were studied. PRU was measured 6-12 months after PCI and subsequently, 6 months later using a P2Y12 assay, respectively. This study evaluated the proportion of bleeding risk (PRU ≤ 85) and ischemic risk (PRU ≥ 239) as primary endpoints, and the prediction of bleeding risk and ischemic risk using multivariable logistic regression analysis. RESULTS At baseline, 136 patients (39%) received prasugrel 3.75 mg, 48 patients (14%) received prasugrel 2.5 mg, and 164 patients (47%) received clopidogrel 75 mg. Clopidogrel 75 mg had a significantly higher proportion of ischemic risk within one year after PCI than the other groups, and was an independent predictor for ischemic risk with reference of prasugrel 3.75 mg. In addition, switching from clopidogrel 75 mg to prasugrel 2.5 mg significantly lowered and aggregated the PRU value. Whereas, dose reduction of prasugrel had a significantly lower proportion of bleeding risk over one year after PCI than the continuation of prasugrel 3.75 mg, and was an independent predictor for bleeding risk with reference of continuation of prasugrel 3.75 mg. CONCLUSIONS Prasugrel 2.5 mg has a lower ischemic risk and a more stable PRU value compared with clopidogrel treatment. Prasugrel also contributes to a decline in bleeding risk with concomitant dose reduction. TRIAL REGISTRATION University Hospital Medical Information Network (UMIN), ID: UMIN000029541, Date: October 16, 2017 ( https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033395 ).
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Affiliation(s)
- Tatsuya Fukase
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Shinichiro Doi
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Tomotaka Dohi
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan.
| | - Takuma Koike
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Ryota Nishio
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Hidetoshi Yasuda
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Mitsuhiro Takeuchi
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Norihito Takahashi
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Yuichi Chikata
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Hirohisa Endo
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Hiroki Nishiyama
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Iwao Okai
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Hiroshi Iwata
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Shinya Okazaki
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Hiroyuki Daida
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
- Department of Radiological Technology, Faculty of Health Science, Juntendo University, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
| | - Satoru Suwa
- Department of Cardiology, Juntendo University Shizuoka Hospital, 1129 Nagaoka, Izunokuni-Shi, 410-2295, Sizuoka, Japan
| | - Tohru Minamino
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
- Japan Agency for Medical Research and Development-Core Research for Evolutionary Medical Science and Technology (AMED-CREST), Japan Agency for Medical Research and Development, 1-7-1 Otemachi, Chiyoda-Ku, Tokyo, 100-0004, Japan
| | - Katsumi Miyauchi
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan
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Zhang S, Wu Y, Lv C, Liu H, Wang Y, Dong L, Liu Y, Wang S, Jia J, Yin T. β1-blockers in the reduction of bleeding risk in patients prescribed with potent dual antiplatelet therapy after acute coronary syndrome or percutaneous coronary intervention. Hellenic J Cardiol 2024; 79:15-24. [PMID: 37783287 DOI: 10.1016/j.hjc.2023.09.017] [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: 04/24/2023] [Revised: 08/14/2023] [Accepted: 09/26/2023] [Indexed: 10/04/2023] Open
Abstract
BACKGROUND β1-blockers could improve clinical outcomes in patients with coronary artery disease by lowering the heart rate, blood pressure, and myocardial contractility. Moreover, recent studies have suggested that β1-blockers may also have the potential to reduce bleeding risk. OBJECTIVES This study aimed to evaluate the association between β1-blockers and bleeding risk in the patients prescribed with potent dual antiplatelet therapy (DAPT) after acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI). METHODS Patients with ACS or undergoing PCI treated by DAPT of ticagrelor and aspirin were consecutively recruited. Follow-up for all eligible patients was conducted for 1 year. Major bleeding outcomes were defined as events that were type ≥2 based on the Bleeding Academic Research Consortium (BARC) criteria. RESULTS A total of 1,113 eligible ticagrelor-treated patients were recruited. During the 1-year follow-up interval, 142 (12.6%) patients experienced BARC ≥2 bleedings including 23 patients (2.1%) suffering BARC ≥3 bleedings, with the most common site of bleeding located in the gastrointestinal tract. β1-blockers treatment was associated with a lower risk of BARC ≥2 bleedings (11.2% vs. 23.3%, adjusted HR: 0.42, 95% CI: 0.28-0.62, P < 0.01). Moreover, metoprolol (11.1% vs. 23.3%, adjusted HR: 0.56, 95% CI: 0.37-0.83, P < 0.01) and bisoprolol (11.3% vs. 23.3%, adjusted HR: 0.56, 95% CI: 0.33-0.96, P = 0.04) had similar effects on the reduction of bleeding risk. CONCLUSION β1-blockers might be beneficial for the reduction of bleeding risk in potent dual antiplatelet therapy patients with ACS or undergoing PCI.
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Affiliation(s)
- Shizhao Zhang
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Yangxun Wu
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Chao Lv
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Haiping Liu
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Yuyan Wang
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Lisha Dong
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Yuqi Liu
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Shengshu Wang
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
| | - Jianjun Jia
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China.
| | - Tong Yin
- Institute of Geriatrics, Beijing Key Laboratory of Aging and Geriatrics, National Clinical Research Center for Geriatric Diseases, Second Medical Center of Chinese PLA General Hospital, No.28 Fu Xing Road, Beijing 100853, China; Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China.
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7
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Corballis N, Bhalraam U, Merinopoulos I, Gunawardena T, Tsampasian V, Wickramarachchi U, Eccleshall S, Vassiliou VS. One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes. J Clin Med 2024; 13:4521. [PMID: 39124787 PMCID: PMC11312761 DOI: 10.3390/jcm13154521] [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: 07/09/2024] [Revised: 07/25/2024] [Accepted: 07/30/2024] [Indexed: 08/12/2024] Open
Abstract
Background/Objectives: The need to determine the safest duration of dual antiplatelet therapy duration after elective angioplasty to reduce bleeding events without an adverse effect on major adverse cardiovascular events (MACE) remains a challenge. Methods: In this investigator-initiated, single-centre cohort study, we identified all patients who underwent PCI for de novo coronary disease for stable angina between January 2015 and November 2019. We compared 1-month and 12-month durations of dual antiplatelet therapy (DAPT) to determine if there was any difference in the primary outcome of major bleeding. The secondary outcome was a patient-oriented composite endpoint of all-cause mortality; any myocardial infarction, stroke, or revascularisation; and the individual components of this composite endpoint. Data were analysed using Cox regression models and cumulative hazard plots. Results: A total of 1025 patients were analysed, of which 340 received 1 month of DAPT and 685 received 12 months of DAPT. There was no difference in major bleeding between the two groups (2.6% vs. 2.5% respectively). On univariable cox regression analysis, no characteristics were predictors of major bleeding. A proportion of 99.7% of patients in the 1-month DAPT arm were treated with a DCB strategy, whilst 93% in the 12-month DAPT group were treated with a DES. There was no difference between the two groups with regards to the composite patient-oriented MACE (11% vs. 12%, respectively) or any individual component of this. These results were unchanged after propensity score matched analysis. Conclusions: A 1-month duration of DAPT, for which 99.7% of patients were treated with a DCB strategy, appears safe and effective when compared with a 12-month duration of DAPT with no difference in major bleeding or MACE.
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Affiliation(s)
- Natasha Corballis
- Centre of Metabolic Health, Norwich Medical School, University of East Anglia, Bob Champion Research and Education, Rosalind Franklin Road, Norwich NR4 7UQ, UK (I.M.)
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
| | - U. Bhalraam
- Centre of Metabolic Health, Norwich Medical School, University of East Anglia, Bob Champion Research and Education, Rosalind Franklin Road, Norwich NR4 7UQ, UK (I.M.)
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
| | - Ioannis Merinopoulos
- Centre of Metabolic Health, Norwich Medical School, University of East Anglia, Bob Champion Research and Education, Rosalind Franklin Road, Norwich NR4 7UQ, UK (I.M.)
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
| | - Tharusha Gunawardena
- Centre of Metabolic Health, Norwich Medical School, University of East Anglia, Bob Champion Research and Education, Rosalind Franklin Road, Norwich NR4 7UQ, UK (I.M.)
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
| | - Vasiliki Tsampasian
- Centre of Metabolic Health, Norwich Medical School, University of East Anglia, Bob Champion Research and Education, Rosalind Franklin Road, Norwich NR4 7UQ, UK (I.M.)
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
| | - Upul Wickramarachchi
- Centre of Metabolic Health, Norwich Medical School, University of East Anglia, Bob Champion Research and Education, Rosalind Franklin Road, Norwich NR4 7UQ, UK (I.M.)
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
| | - Simon Eccleshall
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
| | - Vassilios S. Vassiliou
- Centre of Metabolic Health, Norwich Medical School, University of East Anglia, Bob Champion Research and Education, Rosalind Franklin Road, Norwich NR4 7UQ, UK (I.M.)
- Department of Cardiology, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich NR4 7LJ, UK;
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8
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Jia Y, Zhao Y, Zhang H. Bioinspired Self-Adhesive Multifunctional Lubricated Coating for Biomedical Implant Applications. ACS APPLIED BIO MATERIALS 2024; 7:4307-4322. [PMID: 38954747 DOI: 10.1021/acsabm.4c00144] [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: 07/04/2024]
Abstract
In the realm of clinical applications, the concern surrounding biomedical device-related infections (BDI) is paramount. To mitigate the risk associated with BDI, enhancing surface characteristics such as lubrication and antibacterial efficacy is considered as a strategic approach. This study delineated the synthesis of a multifunctional copolymer, embodying self-adhesive, lubricating, and antibacterial properties, achieved through free radical polymerization and a carbodiimide coupling reaction. The copolymer was adeptly modified on the surface of stainless steel 316L (SS316L) substrates by employing a facile dip-coating technique. Comprehensive characterizations were performed by using an array of analytical techniques including Fourier transform infrared spectroscopy, X-ray photoelectron spectroscopy, optical interferometry, scanning electron microscopy, and atomic force microscopy. Nanoscale tribological assessments revealed a notable reduction in the value of the friction coefficient of the copolymer-coated SS316L substrates compared to bare SS316L samples. The coating demonstrated exceptional resistance to protein adsorption, as evidenced in protein contamination models employing bovine serum albumin and fibrinogen. The bactericidal efficacy of the copolymer-modified surfaces was significantly improved against pathogenic strains such as Staphylococcus aureus and Escherichia coli. Additionally, in vitro evaluations of blood compatibility and cellular compatibility underscored the remarkable anticoagulant performance and biocompatibility. Collectively, these findings indicated that the developed copolymer coating represented a promising candidate, with its facile modification approach, for augmenting lubrication and antifouling properties in the field of biomedical implant applications.
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Affiliation(s)
- Yiran Jia
- Joint Diseases Center, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
- State Key Laboratory of Tribology in Advanced Equipment, Department of Mechanical Engineering, Tsinghua University, Beijing 100084, China
| | - Yanlong Zhao
- State Key Laboratory of Tribology in Advanced Equipment, Department of Mechanical Engineering, Tsinghua University, Beijing 100084, China
| | - Hongyu Zhang
- Joint Diseases Center, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China
- State Key Laboratory of Tribology in Advanced Equipment, Department of Mechanical Engineering, Tsinghua University, Beijing 100084, China
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9
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Khorsandi M, Blumenthal RS, Blaha MJ, Kohli P. The ABCs of the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline for the management of patients with chronic coronary disease. Clin Cardiol 2024; 47:e24284. [PMID: 38766996 PMCID: PMC11103637 DOI: 10.1002/clc.24284] [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: 12/06/2023] [Revised: 04/27/2024] [Accepted: 05/07/2024] [Indexed: 05/22/2024] Open
Abstract
BACKGROUND The 2023 Multisociety Guideline for the Management of Chronic Coronary Disease (CCD) updates recommendations for CCD, formerly known as "stable ischemic heart disease." This condition encompasses a spectrum of coronary vascular pathologies from subclinical to clinical ischemic heart disease. HYPOTHESIS The new "ABC" mnemonic offers clinicians a streamlined framework for applying Class One Recommendations (COR1) and integrating recent updates into CCD management. METHODS A critical analysis of the 2023 CCD guidelines was conducted, with this review highlighting key elements. RESULTS The review outlines crucial changes, including novel recommendations supported by current clinical evidence. The focus is on these developments, clarifying their importance for day-to-day clinical practice. CONCLUSIONS The review encourages a synergistic approach between primary healthcare providers and cardiologists to develop comprehensive strategies for lifestyle modification and medication therapy in CCD care. Furthermore, it suggests that utilizing comprehensive risk assessment tools can refine medical decision-making, ultimately enhancing patient care and clinical outcomes.
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Affiliation(s)
- Michael Khorsandi
- Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular DiseaseBaltimoreMarylandUSA
| | - Roger S. Blumenthal
- Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular DiseaseBaltimoreMarylandUSA
| | - Michael J. Blaha
- Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular DiseaseBaltimoreMarylandUSA
| | - Payal Kohli
- Cardiology Division, Department of MedicineDuke UniversityDurhamNorth CarolinaUSA
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10
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Ortega-Paz L, Franchi F, Rollini F, Galli M, Been L, Ghanem G, Shalhoub A, Ossi T, Rivas A, Zhou X, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Jennings LK, Angiolillo DJ. Switching from Dual Antiplatelet Therapy with Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition with Aspirin Plus Vascular-Dose Rivaroxaban: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study. Thromb Haemost 2024; 124:263-273. [PMID: 37224883 DOI: 10.1055/a-2098-6639] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/26/2023]
Abstract
BACKGROUND To date, there are no data on switching to dual pathway inhibition (DPI) patients who have completed a guideline-recommended dual antiplatelet therapy (DAPT) regimen. OBJECTIVES To assess the feasibility of switching from DAPT to DPI and to compare the pharmacodynamic (PD) profiles of these treatments. METHODS This was a prospective, randomized, PD study conducted in 90 patients with chronic coronary syndrome (CCS) on DAPT with aspirin (81 mg/qd) plus a P2Y12 inhibitor (clopidogrel [75 mg/qd; n = 30], ticagrelor [90 mg/bid; n = 30], or prasugrel [10 mg/qd; n = 30]). Patients in each cohort were randomized to maintain DAPT or switch to DPI (aspirin 81 mg/qd plus rivaroxaban 2.5 mg/bid). PD assessments included: VerifyNow P2Y12 reaction units; light transmittance aggregometry following stimuli with adenosine diphosphate (ADP), tissue factor (TF), and a combination of collagen, ADP, and TF (maximum platelet aggregation %); thrombin generation (TG). Assays were performed at baseline and 30 days postrandomization. RESULTS Switching from DAPT to DPI occurred without major side effects. DAPT was associated with enhanced P2Y12 inhibition, while DPI with reduced TG. Platelet-mediated global thrombogenicity (primary endpoint) showed no differences between DAPT and DPI in the ticagrelor (14.5% [0.0-63.0] vs. 20.0% [0.0-70.0]; p = 0.477) and prasugrel (20.0% [0.0-66.0] vs. 4.0% [0.0-70.0]; p = 0.482), but not clopidogrel (27.0% [0.0-68.0] vs. 53.0% [0.0-81.0]; p = 0.011), cohorts. CONCLUSION In patients with CCS, switching from different DAPT regimens to DPI was feasible, showing enhanced P2Y12 inhibition with DAPT and reduced TG with DPI, with no differences in platelet-mediated global thrombogenicity between DPI and ticagrelor- and prasugrel-, but not clopidogrel-, based DAPT. CLINICAL TRIAL REGISTRATION http://www. CLINICALTRIALS gov Unique Identifier: NCT04006288.
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Affiliation(s)
- Luis Ortega-Paz
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Francesco Franchi
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Fabiana Rollini
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Mattia Galli
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
- Departmet of Cardiology, Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy
| | - Latonya Been
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Ghussan Ghanem
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Awss Shalhoub
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Tiffany Ossi
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Andrea Rivas
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Xuan Zhou
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Andres M Pineda
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Siva Suryadevara
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Daniel Soffer
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | - Martin M Zenni
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
| | | | - Dominick J Angiolillo
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
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11
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Shimono H, Tokushige A, Kanda D, Ohno A, Arikawa R, Chaen H, Okui H, Oketani N, Ohishi M. Comparison of Discriminative Ability of Bleeding Risk Criteria and Scores for Predicting Short- and Mid-Term Major Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention. Circ Rep 2024; 6:4-15. [PMID: 38196402 PMCID: PMC10774022 DOI: 10.1253/circrep.cr-23-0087] [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: 10/24/2023] [Revised: 11/18/2023] [Accepted: 11/23/2023] [Indexed: 01/11/2024] Open
Abstract
Background: This study aimed to compare the discriminative ability of the Japanese Version of High Bleeding Risk (J-HBR), Academic Research Consortium for High Bleeding Risk (ARC-HBR), and Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) scores for predicting major bleeding events. Methods and Results: Between January 2017 and December 2020, 646 consecutive patients who underwent successful percutaneous coronary intervention (PCI) were enrolled. We scored the ARC-HBR and J-HBR criteria by assigning 1 point to each major criterion and 0.5 point to each minor criterion. The primary outcome was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5 bleeding events. According to the J-HBR, ARC-HBR, and PRECISE-DAPT scores, 428 (66.3%), 319 (49.4%), and 282 (43.7%) patients respectively had a high bleeding risk. During the follow-up period (median, 974 days), 44 patients experienced major bleeding events. The area under the curve (AUC) using the time-dependent receiver operating characteristic curve for major bleeding events was 0.84, 0.82, and 0.83 within 30 days and 0.86, 0.83, and 0.80 within 2 years for the J-HBR, ARC-HBR, and PRECISE-DAPT scores, respectively. The AUC values did not differ significantly among the 3 bleeding risk scores. Conclusions: The J-HBR score had a discriminative ability similar to the ARC-HBR and PRECISE-DAPT scores for predicting short- and mid-term major bleeding events.
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Affiliation(s)
- Hirokazu Shimono
- Department of Cardiovascular Medicine, Kagoshima City Hospital Kagoshima Japan
- Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University Kagoshima Japan
| | - Akihiro Tokushige
- Department of Prevention and Analysis of Cardiovascular Diseases, Graduate School of Medical and Dental Sciences, Kagoshima University Kagoshima Japan
- Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus School of Medicine Okinawa Japan
| | - Daisuke Kanda
- Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University Kagoshima Japan
| | - Ayaka Ohno
- Department of Cardiovascular Medicine, Kagoshima City Hospital Kagoshima Japan
| | - Ryo Arikawa
- Department of Cardiovascular Medicine, Kagoshima City Hospital Kagoshima Japan
| | - Hideto Chaen
- Department of Cardiovascular Medicine, Kagoshima City Hospital Kagoshima Japan
| | - Hideki Okui
- Department of Cardiovascular Medicine, Kagoshima City Hospital Kagoshima Japan
| | - Naoya Oketani
- Department of Cardiovascular Medicine, Kagoshima City Hospital Kagoshima Japan
| | - Mitsuru Ohishi
- Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University Kagoshima Japan
- Department of Prevention and Analysis of Cardiovascular Diseases, Graduate School of Medical and Dental Sciences, Kagoshima University Kagoshima Japan
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12
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Shin ES, Her AY, Kim B, Hahn JY, Song YB, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC. Sex-Based Outcomes of P2Y12 Inhibitor Monotherapy After Three Months of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention. J Korean Med Sci 2023; 38:e383. [PMID: 37987108 PMCID: PMC10659928 DOI: 10.3346/jkms.2023.38.e383] [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: 03/18/2023] [Accepted: 08/22/2023] [Indexed: 11/22/2023] Open
Abstract
BACKGROUND In patients undergoing percutaneous coronary intervention (PCI) in the SMART-CHOICE trial, P2Y12 inhibitor monotherapy after three months of dual antiplatelet therapy (DAPT) achieved clinical outcomes comparable to those of 12 months of DAPT. Nonetheless, the effects of sex on these outcomes remain unknown. METHODS This open-label, non-inferiority, randomized study, conducted in 33 hospitals in South Korea, included 2,993 patients undergoing PCI with drug-eluting stents. Patients were randomly assigned to receive DAPT (aspirin plus a P2Y12 inhibitor) for three months then P2Y12 inhibitor alone for nine months, or DAPT for the entire 12 months. The primary endpoints were major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) 12 months after the index procedure. The bleeding endpoints were Bleeding Academic Research Consortium (BARC) bleeding types 2 to 5. RESULTS Of the patients, 795 (26.6%) were women, who were older and had a higher prevalence of hypertension, diabetes, and dyslipidemia than men. The sexes exhibited comparable primary endpoints (adjusted hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.55-1.55; P = 0.770) and bleeding endpoints (adjusted HR, 1.07; 95% CI, 0.63-1.81; P = 0.811). P2Y12 inhibitor monotherapy vs DAPT was associated with lower risk of BARC type 2 to 5 bleeding in women (adjusted HR, 0.40; 95% CI, 0.16-0.98; P = 0.045) but the difference was not statistically significant when using the Bonferroni correction. The primary endpoints were similar between treatment groups in both sexes. CONCLUSION In both sexes undergoing PCI, P2Y12 inhibitor monotherapy after three months of DAPT achieved similar risks of the primary endpoints and the bleeding events compared with prolonged DAPT. Therefore, the benefits of early aspirin withdrawal with ongoing P2Y12 inhibitors may be comparable in women and men. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02079194.
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Affiliation(s)
- Eun-Seok Shin
- Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
| | - Ae-Young Her
- Division of Cardiology, Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University School of Medicine, Chuncheon, Korea
| | - Bitna Kim
- Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
| | - Joo-Yong Hahn
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Young Bin Song
- 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
| | - Taek Kyu Park
- 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
- Department of Emergency 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
| | - Sang Hoon Lee
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Hyeon-Cheol Gwon
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
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13
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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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14
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Sandner S, Redfors B, Gaudino M. Antiplatelet therapy around CABG: the latest evidence. Curr Opin Cardiol 2023; 38:484-489. [PMID: 37751394 PMCID: PMC10552805 DOI: 10.1097/hco.0000000000001078] [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: 09/28/2023]
Abstract
PURPOSE OF REVIEW The optimal antiplatelet strategy in patients after coronary artery bypass graft (CABG) surgery is unclear. We review the evidence on the efficacy and safety of DAPT after CABG and discuss potential novel antiplatelet strategies that reduce the risk of bleeding without loss of efficacy. RECENT FINDINGS Adding the potent P2Y12 inhibitor ticagrelor to aspirin for 1 year after CABG is associated with a reduction in the risk of vein graft failure, at the expense of an increased risk of clinically important bleeding. Ticagrelor monotherapy is not associated with better efficacy than aspirin alone, but is not associated with increased bleeding risk. SUMMARY Dual antiplatelet therapy (DAPT) is recommended after acute coronary syndrome events, but aspirin as single antiplatelet therapy remains the cornerstone of antithrombotic therapy in stable ischemic heart disease because of a lack of solid evidence on the benefit of DAPT on clinical outcomes. Shorter duration DAPT, based on the pathophysiology of vein graft failure, may be a promising strategy that requires testing in adequately powered randomized trials.
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Affiliation(s)
- Sigrid Sandner
- Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria
| | - Björn Redfors
- Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Mario Gaudino
- Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York, USA
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15
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Jun EJ, Hong SP, Kim B, Lee JB, Shin ES. Healing and stent coverage with the new ultrathin sirolimus-eluting stent with abluminal biodegradable polymer. Catheter Cardiovasc Interv 2023; 102:1040-1047. [PMID: 37855180 DOI: 10.1002/ccd.30871] [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: 05/02/2023] [Revised: 09/11/2023] [Accepted: 10/05/2023] [Indexed: 10/20/2023]
Abstract
BACKGROUND Genoss drug-eluting stent (DES) (Genoss Company Limited) is a new ultrathin sirolimus-eluting stent with an abluminal biodegradable polymer and a cobalt-chromium platform. AIMS The aim of this study was to evaluate vascular healing and neointimal coverage after implantation of the Genoss DES using optical coherence tomography (OCT) 6 months postimplantation. METHODS From August 22, 2019 to June 17, 2020, this multicenter, observational, investigator-initiated study enrolled 20 patients who underwent OCT examination 6 months after Genoss DES implantation and provided informed consent. An analyst, blinded to the patients' and procedural information analyzed OCT images at an independent core laboratory. RESULTS Of the 20 patients, 19 with 27 stents in 21 lesions from 21 vessels were included in the analysis, while one patient withdrew consent and was unwilling to undergo follow-up OCT. OCT analysis was performed 204.4 ± 31.9 days after Genoss DES implantation. A total of 4285 stent struts from 661 cross-sections were analyzed. Strut tissue coverage was observed in 98.7 ± 4.3% of struts, with 0.1 ± 1.2% malapposed struts per lesion. The mean thickness of neointimal hyperplasia (NIH) on the covered struts was 0.12 ± 0.04 mm. CONCLUSIONS Six months after stent implantation, most Genoss DES struts were covered with a thin layer of NIH that was evenly distributed along the stent length. This pilot study evaluated the outcomes of 6 months dual antiplatelet therapy in the context of ultrathin strut stents, providing insight into developing ethical standards and a scientific foundation for conducting an adequately designed clinical trial.
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Affiliation(s)
- Eun Jung Jun
- Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
| | - Seung-Pyo Hong
- Department of Cardiology, School of Medicine, Catholic University of Daegu, Daegu, South Korea
| | - Bitna Kim
- Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
| | - Jin Bae Lee
- Department of Cardiology, School of Medicine, Catholic University of Daegu, Daegu, South Korea
| | - Eun-Seok Shin
- Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
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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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17
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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: 476] [Impact Index Per Article: 238.0] [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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18
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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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19
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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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20
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Kim S, Lee JS, Lee J, Kim YH, Kim JS, Lim SY, Kim SH, Ahn JC, Song WH. Fifteen-Year Nationwide Trend in Antiplatelet Treatment among Drug-Eluting Stent Recipients in Korea: Many Patients Receive Very Prolonged Dual-Antiplatelet Treatment, and Newer Drugs Are Replacing the Older Ones. J Clin Med 2023; 12:jcm12072675. [PMID: 37048759 PMCID: PMC10095404 DOI: 10.3390/jcm12072675] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2023] [Revised: 03/21/2023] [Accepted: 03/31/2023] [Indexed: 04/07/2023] Open
Abstract
Drug-eluting stent (DES) recipients require 6–12 months of dual antiplatelet treatment (DAPT) and long-term aspirin mono-antiplatelet treatment (MAPT). Given the diversity of contemporary antiplatelet agents, antiplatelet treatment (APT) selection is becoming more complicated. We evaluated 15-year APT trends based on nationwide prescription data of 79,654 patients who underwent percutaneous coronary intervention (PCI) using DESs from 2002 to 2018 in Korea. DAPT (80.7%) was the most preferred initial APT post-PCI. Many DES recipients received prolonged DAPT (post-PCI 3 years: 41.0%; 10 years: 27.7%). There was a noticeable delay in DAPT-to-MAPT conversion from the mid to late 2000s (after the late-stent thrombosis concerns of first-generation DESs raised); the conversion after that was similar during the 2010s, occurring most robustly at 12–18 months post-PCI. Clopidogrel had long and increasingly been used for MAPT, surpassing aspirin. The recent increase in newer P2Y12 inhibitor prescriptions was noted. The patients treated with newer P2Y12 inhibitors were more likely younger men and presented with acute myocardial infarction. Real-world APT is evolving, and guideline–practice gaps exist. Further studies exploring the impact of diverse APT strategies on patient outcomes are expected to provide insights into optimal APT that can sophisticatedly balance the ischemic and bleeding risks.
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Affiliation(s)
- Sunwon Kim
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
| | - Jong-Seok Lee
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
| | - Jungkuk Lee
- Hanmi Pharmaceuticals, Songpa-gu, Seoul 05545, Republic of Korea
| | - Yong-Hyun Kim
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
| | - Jin-Seok Kim
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
| | - Sang-Yup Lim
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
| | - Seong Hwan Kim
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
| | - Jeong-Cheon Ahn
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
| | - Woo-Hyuk Song
- Cardiovascular Center, Korea University Ansan Hospital, Ansan-si 15355, Republic of Korea
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21
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Bolognese L, Reccia MR, Sabini A. Long-term follow-up after invasive or conservative management of stable coronary disease: the ISCHEMIA-EXTEND study. Eur Heart J Suppl 2023; 25:B34-B36. [PMID: 37091658 PMCID: PMC10120994 DOI: 10.1093/eurheartjsupp/suad064] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/25/2023]
Abstract
The ISCHEMIA trial found no statistical difference in the primary endpoint between initial invasive and conservative management of patients with chronic coronary disease and moderate-to-severe ischaemia on stress testing. However, an invasive strategy increased peri-procedural myocardial infarction (MI) but decreased spontaneous MI with continued separation of curves over time. Thus, in order to assess the long-term effect of invasive management strategy on mortality, the ISCHEMIA-EXTEND observational study was planned including surviving participants from the initial phase of the ISCHEMIA trial with a projected median follow-up of nearly 10 years. Recently, an interim report of 7-year all-cause, cardiovascular (CV), and non-CV mortality rates has been published showing no difference in all-cause mortality between the two strategies, but with a lower risk of CV mortality and higher risk of non-CV mortality with an initial invasive strategy over a median follow-up of 5.7 years. The trade-offs in CV and non-CV mortality observed in ISCHEMIA-EXTEND raise many important questions regarding the heterogeneity of treatment effect, the drivers of mortality, and the relative importance and reliability of CV vs. all-cause mortality. Overall, findings from ISCHEMIA and ISCHEMIA-EXTEND trials might help physicians in shared decision-making as to whether to add invasive management to guideline-directed medical management in selected patients with chronic coronary artery disease and moderate or severe ischaemia.
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Affiliation(s)
| | - Matteo Rocco Reccia
- Cardiovascular Department, Azienda Ospedaliera Toscana Sudest, Arezzo, Italy
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22
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Zhou T, Gong Y, Li J, Wang Y, Wang X. Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority randomized controlled trial. Trials 2023; 24:209. [PMID: 36945020 PMCID: PMC10031942 DOI: 10.1186/s13063-023-07236-w] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2022] [Accepted: 03/10/2023] [Indexed: 03/23/2023] Open
Abstract
BACKGROUND Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI) to antithrombosis, meanwhile, increasing the risks of gastrointestinal bleeding. Rivaroxaban, a novel oral anticoagulant, combined with a P2Y12 receptor inhibitor reduces adverse events in patients with CHD and atrial fibrillation who underwent PCI. The effect of rivaroxaban plus P2Y12 inhibitor on reducing bleeding events in patients with CHD and gastrointestinal disease (GID) undergoing PCI remains unclear. METHOD The study is a prospective, single-center, randomized controlled trial. A total of 1020 patients with CHD and GID undergoing PCI will be enrolled. Patients are randomized (1:1) to receive either rivaroxaban 10 mg plus clopidogrel 75 mg daily or aspirin 100 mg plus clopidogrel 75 mg daily; both treatments will last 6 months. The primary endpoint is Bleeding Academic Research Consortium (BARC) type 2-5 bleeding requiring medical intervention. The secondary endpoint is a composite of major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization, and stroke. DISCUSSION The objective of this study is to evaluate the efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with CHD and GID undergoing PCI. We aim to explore an optimized antithrombotic strategy, which achieves the same anti-ischemic effect as standard DAPT without increasing the risk of GIB, for patients with CHD and GID undergoing PCI. TRIAL REGISTRATION This protocol is registered at the Chinese Clinical Trial Registry under the number ChiCTR2100044319. And this publication is based on version 1.4 of the trial protocol dated Sep 6, 2021.
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Affiliation(s)
- Tienan Zhou
- Department of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China
| | - Yinghui Gong
- Department of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China
| | - Jingyuan Li
- Department of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China
| | - Yasong Wang
- Department of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China
| | - Xiaozeng Wang
- Department of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China.
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23
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Japanese high bleeding risk criteria status predicts low thrombogenicity and bleeding events in patients undergoing percutaneous coronary intervention. Cardiovasc Interv Ther 2023:10.1007/s12928-023-00920-3. [PMID: 36877333 DOI: 10.1007/s12928-023-00920-3] [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: 10/13/2022] [Accepted: 02/13/2023] [Indexed: 03/07/2023]
Abstract
Although the Japanese high bleeding risk criteria (J-HBR) were established to predict bleeding risk in patients undergoing percutaneous coronary intervention (PCI), the thrombogenicity in the J-HBR status remains unknown. Here, we examined the relationships among J-HBR status, thrombogenicity and bleeding events. This study was a retrospective analysis of 300 consecutive patients who underwent PCI. Blood samples obtained on the day of PCI were used in the total thrombus-formation analysis system (T-TAS) to investigate the thrombus-formation area under the curve (AUC; PL18-AUC10 for platelet chip; AR10-AUC30 for atheroma chip). The J-HBR score was calculated by adding 1 point for any major criterion and 0.5 point for any minor criterion. We assigned patients to three groups based on J-HBR status: a J-HBR-negative group (n = 80), a low score J-HBR-positive group (positive/low, n = 109), and a high score J-HBR-positive group (positive/high, n = 111). The primary end point was the 1-year incidence of bleeding events defined by the Bleeding Academic Research Consortium types 2, 3, or 5. Both PL18-AUC10 and AR10-AUC30 levels were lower in the J-HBR-positive/high group than the negative group. Kaplan-Meier analysis showed worse 1-year bleeding event-free survival in the J-HBR-positive/high group compared with the negative group. In addition, both T-TAS levels in J-HBR positivity were lower in those with bleeding events than in those without bleeding events. In multivariate Cox regression analyses, the J-HBR-positive/high status was significantly associated with 1-year bleeding events. In conclusion, the J-HBR-positive/high status could reflect low thrombogenicity as measured by T-TAS and high bleeding risk in patients undergoing PCI.
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24
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Masuda S, Muramatsu T, Ishibashi Y, Kozuma K, Tanabe K, Nakatani S, Kogame N, Nakamura M, Asano T, Okamura T, Miyazaki Y, Tateishi H, Ozaki Y, Nakazawa G, Morino Y, Katagiri Y, Garg S, Hara H, Ono M, Kawashima H, Lemos PA, Serruys PW, Onuma Y. Reduced-dose prasugrel monotherapy without aspirin after PCI with the SYNERGY stent in East Asian patients presenting with chronic coronary syndromes or non-ST-elevation acute coronary syndromes: rationale and design of the ASET Japan pilot study. ASIAINTERVENTION 2023; 9:39-48. [PMID: 36936091 PMCID: PMC10018289 DOI: 10.4244/aij-d-22-00033] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/10/2022] [Accepted: 09/01/2022] [Indexed: 06/18/2023]
Abstract
The Acetyl Salicylic Elimination Trial (ASET) Japan pilot study is a multicentre, single-arm, open-label, proof-of-concept study with a stopping rule based on the occurrence of definite stent thrombosis. This study aims to demonstrate the feasibility and safety of low-dose prasugrel monotherapy following percutaneous coronary intervention (PCI) in Japanese patients presenting with chronic coronary syndromes (CCS) or non-ST-elevation acute coronary syndromes (NSTE-ACS). Four hundred patients with a SYNTAX score <23 requiring PCI due to CCS or NSTE-ACS will be screened and considered eligible for the study. The enrolment is planned in two phases: 1) 200 patients presenting with CCS, followed by 2) 200 patients presenting with NSTE-ACS. After optimal PCI with implantation of a SYNERGY (Boston Scientific) stent, patients will be enrolled and loaded with prasugrel 20 mg, followed by a maintenance dose of prasugrel 3.75 mg once daily without aspirin continued for 3 months in Phase 1 (CCS patients), and for 12 months in Phase 2 (NSTE-ACS patients). After these follow-up periods, prasugrel will be replaced by standard antiplatelet therapy according to local practice. The primary endpoint is a composite of cardiac death, target vessel myocardial infarction, or definite stent thrombosis after the index procedure. The primary bleeding endpoint is any Bleeding Academic Research Consortium type 3 or 5 bleeding occurring within 3 months of the index PCI for CCS patients, or 12 months for NSTE-ACS patients. The ASET Japan study is designed to demonstrate the feasibility and safety of reduced-dose prasugrel monotherapy after PCI in East Asian patients with acute and chronic coronary syndromes.
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Affiliation(s)
- Shinichiro Masuda
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Takashi Muramatsu
- Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan
| | - Yuki Ishibashi
- Division of Cardiology, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan
| | - Ken Kozuma
- Department of Cardiology, Teikyo University Hospital, Tokyo, Japan
| | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Shimpei Nakatani
- Department of Cardiology, JCHO Hoshigaoka Medical Center, Osaka, Japan
| | - Norihiro Kogame
- Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan
| | - Masato Nakamura
- Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan
| | - Taku Asano
- Department of Cardiology, St. Luke's International Hospital, Tokyo, Japan
| | - Takayuki Okamura
- Division of Cardiology, Department of Clinical Science and Medicine, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
| | - Yosuke Miyazaki
- Division of Cardiology, Department of Clinical Science and Medicine, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
| | - Hiroki Tateishi
- Division of Cardiology, Department of Clinical Science and Medicine, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
- Department of Cardiology, Shibata Hospital, Aichi, Japan
| | - Yukio Ozaki
- Department of Cardiology, Fujita Health University Okazaki Medical Center, Aichi, Japan
| | - Gaku Nakazawa
- Department of Cardiology, Kindai University Faculty of Medicine, Osaka, Japan
| | - Yoshihiro Morino
- Department of Cardiology, Iwate Medical University Hospital, Iwate, Japan
| | - Yuki Katagiri
- Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan
| | - Scot Garg
- Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK
| | - Hironori Hara
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Masafumi Ono
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Hideyuki Kawashima
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
- Department of Cardiology, Teikyo University Hospital, Tokyo, Japan
| | - Pedro A Lemos
- Heart Institute (InCor), University of São Paulo, São Paulo, Brazil
- Hospital Israelita Albert Einstein, São Paulo, Brazil
| | - Patrick W Serruys
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Yoshinobu Onuma
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
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25
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Cirillo P, DI Serafino L, Gamra H, Zimarino M, Barbato E, Briguori C, Amat-Santos IJ, Chieffo A, Erglis A, Gil RJ, Kedev SA, Petrov I, Radico F, Niglio T, Nakamura S, Costa RA, Kanic V, Perfetti M, Pellicano M, Maric K, Tesorio T, Vukcevic V, Esposito G, Stankovic G. Impact of dual antiplatelet therapy duration on clinical outcome after coronary bifurcation stenting: results from the EuroBifurcation Club registry. Panminerva Med 2023; 65:1-12. [PMID: 35546730 DOI: 10.23736/s0031-0808.22.04604-3] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
BACKGROUND Optimal duration of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. METHODS We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of major adverse cardiac and cardiovascular events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as Bleeding Academic Research Consortium (BARC) ≥3 were evaluated too. RESULTS Patients were divided into 3 groups: short DAPT (<6-months, N.=375); standard DAPT (≥6-months but ≤12-months, N.=636); prolonged DAPT (>12-months, N.=1273). At 24 months follow-up MACCE-free survival was significantly lower in short DAPT patients (Log-Rank: 45.23, P for trend <0.001). MACCE occurred less frequently in the prolonged DAPT group (148 [11.6%]) as compared with both the short (83 [22.1%] HR: 0.48 [0.37-0.63], P<0.001) and standard DAPT groups (137 [21.5%] HR:0.51 [0.41-0.65], P<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 [0.20-0.36] and HR: 0.44 [0.34-0.57]). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC≥3 bleedings were 0.3% in the standard DAPT, 1.6% in short and 1.9% in prolonged DAPT groups. CONCLUSIONS In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.
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Affiliation(s)
- Plinio Cirillo
- Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy -
| | - Luigi DI Serafino
- Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
| | - Habib Gamra
- Department of Cardiology, Fattouma Bourguiba Hospital, University of Monastir, Monastir, Tunisia
| | - Marco Zimarino
- Institute of Cardiology, G. D'Annunzio University, Chieti, Italy
- Interventional Cath Lab, ASL 2 Abruzzo, Chieti, Italy
| | - Emanuele Barbato
- Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
- CIBERCV, University Clinical Hospital of Valladolid, Valladolid, Spain
| | | | | | - Alaide Chieffo
- Unit of Interventional Cardiology, IRCCS San Raffaele Hospital, Milan, Italy
| | - Andrejs Erglis
- Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
| | - Robert J Gil
- Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland
| | - Sasko A Kedev
- University Clinic of Cardiology Skopje, Skopje, Macedonia
| | | | - Francesco Radico
- Institute of Cardiology, G. D'Annunzio University, Chieti, Italy
| | - Tullio Niglio
- Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
| | - Sunao Nakamura
- Department of Cardiology, New Tokyo Hospital, Chiba, Japan
| | | | - Vojko Kanic
- Department of Cardiology and Angiology, University Medical Centre, Maribor, Slovenia
| | | | - Mariano Pellicano
- Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
- CIBERCV, University Clinical Hospital of Valladolid, Valladolid, Spain
- Laboratory of Invasive Cardiology, Montevergine Clinic, Mercogliano, Avellino, Italy
| | - Kristina Maric
- Department of Cardiovascular Medicine, University Hospital Centre, Zagreb, Croatia
| | - Tullio Tesorio
- Laboratory of Invasive Cardiology, Montevergine Clinic, Mercogliano, Avellino, Italy
| | - Vladan Vukcevic
- Department of Cardiology, Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia
| | - Giovanni Esposito
- Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
| | - Goran Stankovic
- Department of Cardiology, Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia
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26
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Kojima M. Adjusted closed-form confidence interval formulas for network meta-analysis with a small number of studies. Stat Med 2023; 42:457-469. [PMID: 36539211 DOI: 10.1002/sim.9626] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2022] [Revised: 09/10/2022] [Accepted: 11/24/2022] [Indexed: 12/24/2022]
Abstract
We derive simple formulas for closed-form confidence intervals for the Wald statistic, likelihood ratio statistic, and score statistic for network meta-analysis (NMA). Additionally, we consider resolutions of concerns that network meta-analyzes with a small number of studies cannot maintain a nominal confidence level. For bias adjustment in analyzes with a small number of studies, the Bartlett-type adjustment is a well-known method. Many Bartlett-type adjustment-type methods are based on maximum likelihood estimators (MLEs). However, NMA often uses restricted MLEs that have not been extensively discussed with respect to the Bartlett-type adjustment. In this article, we propose a Bartlett-type adjustment method for the Wald statistic, likelihood ratio statistic, and score statistic when nuisance parameters are estimated by not only the maximum likelihood method but also the restricted maximum likelihood method. We can compute closed-form confidence intervals adjusted using the Bartlett-type adjustment immediately without any numerical calculations (eg, bootstrap method). Additionally, we propose a higher-order adjustment by applying the bootstrap method to Bartlett-type adjusted statistics. Using a computer simulation, we confirmed that the adjusted confidence intervals maintained a nominal confidence level. Additionally, we confirmed that the confidence intervals of the Wald statistic, likelihood ratio statistic, and score statistic based on the restricted maximum likelihood method performed well without further bootstrap adjustment and the performances of the three adjusted confidence intervals were comparable. Finally, we demonstrated that confidence intervals were adjusted for actual NMA. In the actual NMA, the adjusted confidence intervals of the Wald statistic were wider, the adjusted confidence intervals of the likelihood ratio statistic were also wider, and the adjusted confidence intervals of the score statistic were narrower. We recommend using the likelihood ratio test statistic with the restricted maximum likelihood estimator; however, just in case, we recommend applying the Bartlett-type adjustment to remove the second order bias. From demonstrations in actual studies, we confirmed that the adjusted confidence intervals improved compared with the naive confidence intervals.
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Affiliation(s)
- Masahiro Kojima
- Biometrics Department, Kyowa Kirin Co., Ltd., Tokyo, Japan.,Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Tokyo, Japan
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Natsuaki M, Node K. De-Escalation Therapy After PCI in ACS Patients With Chronic Kidney Disease. JACC. ASIA 2023; 3:62-64. [PMID: 36873761 PMCID: PMC9982280 DOI: 10.1016/j.jacasi.2022.10.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 01/12/2023]
Affiliation(s)
- Masahiro Natsuaki
- Department of Cardiovascular Medicine, Saga University Hospital, Saga, Japan
| | - Koichi Node
- Department of Cardiovascular Medicine, Saga University Hospital, Saga, Japan
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Exploring the potential cost-effectiveness of a novel platelet assay for guiding dual antiplatelet therapy duration in acute coronary syndrome patients following percutaneous coronary intervention. Coron Artery Dis 2023; 34:24-33. [PMID: 36484217 DOI: 10.1097/mca.0000000000001194] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
OBJECTIVE Duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) influences ischemic and bleeding events. Platelet expression of constant fragment of immunoglobulin, low affinity IIa, receptor (FcγRIIa) independently predicts risk of ischemic complications and is proposed as a tool to guide individualized care. METHODS We used a Markov model to predict lifetime ischemic and bleeding events and healthcare costs in acute myocardial infarction (MI) patients treated with PCI and DAPT and to project cost-effectiveness of platelet FcγRIIa-assay-guided care (30:3 months DAPT for patients at high: low ischemic risk) versus current standard care (12 months DAPT) from the perspective of the US healthcare system. Model inputs included assay sensitivity and specificity, ischemic and bleeding event rates, and impacts on quality of life, mortality, and costs. Assay cost was $90. Sensitivity analyses were conducted over a range of plausible clinical and cost assumptions. RESULTS Under base case assumptions, platelet FcγRIIa-assay-guided DAPT duration was projected to increase lifetime costs by $19 versus standard care, with an associated incremental cost-effectiveness ratio (ICER) of $436 per quality-adjusted life-year (QALY) gained. Assay-guided DAPT duration was consistent with high-value care (ICER < $50 000/QALY gained) over a broad range of alternative assumptions. CONCLUSION Based on a decision-analytic model, for patients with MI treated with PCI, the additional costs of the platelet FcγRIIa assay for guiding DAPT duration would be largely offset by reductions in downstream event-related costs, and assay-guided care would be highly cost-effective by current standards. These findings require confirmation in prospective studies and in a randomized clinical trial of assay-guided versus nonassay-guided DAPT duration.
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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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Elliott J, Kelly SE, Bai Z, Skidmore B, Boucher M, So D, Wells GA. Extended dual antiplatelet therapy following percutaneous coronary intervention in clinically important patient subgroups: a systematic review and meta-analysis. CMAJ Open 2023; 11:E118-E130. [PMID: 36750248 PMCID: PMC9911127 DOI: 10.9778/cmajo.20210119] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/09/2023] Open
Abstract
BACKGROUND Dual antiplatelet therapy (DAPT) is routinely given to patients after percutaneous coronary intervention (PCI) with stenting; however, optimal duration remains uncertain in some situations. We assessed the benefits and harms of extending DAPT beyond 1 year after PCI in clinically important patient subgroups. METHODS We conducted a systematic review and meta-analysis. We searched electronic databases (Embase, MEDLINE, PubMed, Cochrane Library) and grey literature (from inception to Nov. 5, 2021) and included randomized controlled trials (RCTs) of extended DAPT (> 12 mo) compared with DAPT for 6-12 months following PCI with stenting. The primary outcome was death (all cause, cardiovascular, noncardiovascular); secondary outcomes included major adverse cardiovascular and cerebrovascular events, myocardial infarction (MI), stroke, stent thrombosis and bleeding. Subgroups were based on prespecified patient characteristics (prior MI, acute coronary syndrome [ACS], diabetes mellitus, age, smoking status). Data were analyzed by random-effects pairwise meta-analysis. RESULTS We identified 9 RCTs that provided subgroup data. We found that extended DAPT reduced the risk of MI and stent thrombosis but increased the risk of bleeding, compared with standard DAPT, with no difference in the risk of all-cause death (relative risk [RR] 1.07, 95% confidence interval [CI] 0.80-1.42) or cardiovascular death (RR 0.98, 95% CI 0.74-1.30). We found that patients with a prior MI, with ACS at presentation, without diabetes or aged younger than 75 years may derive the most benefit from extended DAPT. Among patients who received extended DAPT, the risk of all-cause death was significantly increased among those with no prior MI (RR 1.64, 95% CI 1.08-2.24), whereas there was no significant difference in the risk of all-cause death between standard and extended DAPT for patients with ACS (RR 1.20, 95% CI 0.51-2.83), with diabetes (RR 1.27, 95% CI 0.86-1.89), aged older than 75 years (RR 1.32, 95% CI 0.39-4.54) or who smoked (RR 0.90, 95% CI 0.42-1.92). Similar results were found for cardiovascular death, where data were available. INTERPRETATION Patients with a previous MI with ACS at presentation, without diabetes, or aged younger than 75 years may derive the most benefit from extended DAPT. These findings support the need for careful selection of patients who may benefit most from extended DAPT. STUDY REGISTRATION PROSPERO no. CRD42018082587.
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Affiliation(s)
- Jesse Elliott
- Cardiovascular Research Methods Centre (Elliott, Kelly, Bai, Skidmore, Wells), University of Ottawa Heart Institute; School of Epidemiology and Public Health (Kelly, Wells), University of Ottawa; Ottawa Hospital Research Institute (Skidmore); Canadian Agency for Drugs and Technologies in Health (CADTH) (Boucher); Division of Cardiology (So), University of Ottawa Heart Institute, Ottawa, Ont
| | - Shannon E Kelly
- Cardiovascular Research Methods Centre (Elliott, Kelly, Bai, Skidmore, Wells), University of Ottawa Heart Institute; School of Epidemiology and Public Health (Kelly, Wells), University of Ottawa; Ottawa Hospital Research Institute (Skidmore); Canadian Agency for Drugs and Technologies in Health (CADTH) (Boucher); Division of Cardiology (So), University of Ottawa Heart Institute, Ottawa, Ont
| | - Zemin Bai
- Cardiovascular Research Methods Centre (Elliott, Kelly, Bai, Skidmore, Wells), University of Ottawa Heart Institute; School of Epidemiology and Public Health (Kelly, Wells), University of Ottawa; Ottawa Hospital Research Institute (Skidmore); Canadian Agency for Drugs and Technologies in Health (CADTH) (Boucher); Division of Cardiology (So), University of Ottawa Heart Institute, Ottawa, Ont
| | - Becky Skidmore
- Cardiovascular Research Methods Centre (Elliott, Kelly, Bai, Skidmore, Wells), University of Ottawa Heart Institute; School of Epidemiology and Public Health (Kelly, Wells), University of Ottawa; Ottawa Hospital Research Institute (Skidmore); Canadian Agency for Drugs and Technologies in Health (CADTH) (Boucher); Division of Cardiology (So), University of Ottawa Heart Institute, Ottawa, Ont
| | - Michel Boucher
- Cardiovascular Research Methods Centre (Elliott, Kelly, Bai, Skidmore, Wells), University of Ottawa Heart Institute; School of Epidemiology and Public Health (Kelly, Wells), University of Ottawa; Ottawa Hospital Research Institute (Skidmore); Canadian Agency for Drugs and Technologies in Health (CADTH) (Boucher); Division of Cardiology (So), University of Ottawa Heart Institute, Ottawa, Ont
| | - Derek So
- Cardiovascular Research Methods Centre (Elliott, Kelly, Bai, Skidmore, Wells), University of Ottawa Heart Institute; School of Epidemiology and Public Health (Kelly, Wells), University of Ottawa; Ottawa Hospital Research Institute (Skidmore); Canadian Agency for Drugs and Technologies in Health (CADTH) (Boucher); Division of Cardiology (So), University of Ottawa Heart Institute, Ottawa, Ont
| | - George A Wells
- Cardiovascular Research Methods Centre (Elliott, Kelly, Bai, Skidmore, Wells), University of Ottawa Heart Institute; School of Epidemiology and Public Health (Kelly, Wells), University of Ottawa; Ottawa Hospital Research Institute (Skidmore); Canadian Agency for Drugs and Technologies in Health (CADTH) (Boucher); Division of Cardiology (So), University of Ottawa Heart Institute, Ottawa, Ont.
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Lee KY, Hwang BH, Choo EH, Lim S, Kim CJ, Kim JJ, Byeon J, Choi IJ, Oh GC, Choi YS, Yoo KD, Chung WS, Ahn Y, Jeong MH, Chang K. Clinical benefit of long-term use of dual antiplatelet therapy for acute myocardial infarction patients with the PEGASUS-TIMI 54 criteria. Front Cardiovasc Med 2022; 9:1017533. [DOI: 10.3389/fcvm.2022.1017533] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2022] [Accepted: 10/24/2022] [Indexed: 11/18/2022] Open
Abstract
BackgroundWe evaluated the effectiveness of extended dual antiplatelet therapy (DAPT) usage after 2nd-generation drug elution stent implantation in acute myocardial infarction (AMI) survivors with high ischemic risk characteristics who had no major bleeding for 24 months under at least 1 year of DAPT maintenance.Materials and methodsThe primary ischemic and bleeding endpoints were the risk of mortality and the risk of BARC 3 or 5 (major) bleeding. We investigated the event rates for 2–5 years after the index procedure.ResultsOf 3382 post-AMI survivors who met the PEGASUS-TIMI 54 (PEGASUS) criteria and without major bleeding until 2 years, 2281 (67.4%) maintained DAPT over 24 months, and 1101 (32.5%) switched DAPT to a single antiplatelet agent. The >24 M DAPT group showed a lower risk of mortality than the 12–24 M DAPT group (7.2 vs. 9.2%; adjusted hazard ratio: 0.648; 95% confidence interval: 0.595–0.976; p < 0.001). The mortality risk was significantly greater as the number of PEGASUS criteria increased (p < 0.001). DAPT > 24 months was not significantly associated with a decreased risk for major bleeding in the population meeting the PEGASUS criteria (2.0 vs. 1.1%; p = 0.093). The results were consistent after propensity-score matching and inverse probability weighting to adjust for baseline differences.ConclusionExtended DAPT over 24 months was associated with a lower risk of mortality without increasing the risk of major bleeding among 2 years survivors after AMI who met the PEGASUS criteria and had no major bleeding events before 24 months.
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Palmerini T, Bruno AG, Gasparini M, Rizzello G, Kim HS, Kang J, Park KW, Hahn JY, Song YB, Gwon HC, Choo EH, Park MW, Kim CJ, Chang K, Cuisset T, Taglieri N, Kim BK, Jang Y, Nardi E, Saia F, Orzalkiewicz M, Chietera F, Ghetti G, Galiè N, Stone GW. Reduced Mortality With Antiplatelet Therapy Deescalation After Percutaneous Coronary Intervention in Acute Coronary Syndromes: A Meta-Analysis. Circ Cardiovasc Interv 2022; 15:906-914. [PMID: 36378738 DOI: 10.1161/circinterventions.122.012245] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Antiplatelet therapy deescalation has been suggested as an alternative to standard treatment with potent dual antiplatelet therapy (DAPT) for 1 year in low bleeding risk patients with acute coronary syndromes undergoing percutaneous coronary intervention to mitigate the increased risk of bleeding. Whether this strategy preserves the ischemic and survival benefits of potent DAPT is uncertain. METHODS We performed a pairwise meta-analysis in patients with acute coronary syndrome undergoing percutaneous coronary intervention treated with either 1-year standard potent DAPT versus deescalation therapy (potent DAPT for 1-3 months followed by either reduced potency DAPT or ticagrelor monotherapy for up to 1 year). Randomized trials comparing standard DAPT versus deescalation therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary end point was 1-year all-cause mortality. RESULTS The meta-analysis included 6 trials in which 20 837 patients were randomized to potent DAPT for 1 to 3 months followed by deescalation therapy for up to 1 year (n=10 392) or standard potent DAPT for 1 year (n=10 445). Deescalation therapy was associated with lower 1-year rates of all-cause mortality compared with standard therapy (odds ratio, 0.75 [95% CI, 0.59-0.95]; P=0.02). Deescalation therapy was also associated with lower rates of major bleeding (odds ratio, 0.59 [95% CI, 0.48-0.72]; P<0.0001), with no significant difference in major adverse cardiac events (major adverse cardiovascular events; odds ratio, 0.89 [95% CI, 0.77-1.04]; P=0.14). CONCLUSIONS In low bleeding risk patients with acute coronary syndrome undergoing percutaneous coronary intervention, compared with 1-year of potent DAPT, antiplatelet therapy deescalation therapy after 1 to 3 months was associated with decreased mortality and major bleeding with similar rates of major adverse cardiovascular events.
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Affiliation(s)
- Tullio Palmerini
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Antonio Giulio Bruno
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Mauro Gasparini
- Dipartimento di Scienze Matematiche, Politecnico di Torino, Italy (M.G., G.R.)
| | - Giulia Rizzello
- Dipartimento di Scienze Matematiche, Politecnico di Torino, Italy (M.G., G.R.)
| | - Hyo-Soo Kim
- Severance Cardiovascular Hospital and Science Institute, Yonsei University College of Medicine, Seoul, South Korea (H.-S.K., J.K., K.-W.P.)
| | - Jeehoon Kang
- Severance Cardiovascular Hospital and Science Institute, Yonsei University College of Medicine, Seoul, South Korea (H.-S.K., J.K., K.-W.P.)
| | - Kyung-Woo Park
- Severance Cardiovascular Hospital and Science Institute, Yonsei University College of Medicine, Seoul, South Korea (H.-S.K., J.K., K.-W.P.)
| | - Joo-Yong Hahn
- Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (J.-Y.H., Y.B.S., H.-C.G.)
| | - Young Bin Song
- Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (J.-Y.H., Y.B.S., H.-C.G.)
| | - Hyeon-Cheol Gwon
- Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (J.-Y.H., Y.B.S., H.-C.G.)
| | - Eun Ho Choo
- Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of South Korea (E.H.C., K.C.)
| | - Mahn-Won Park
- Division of Cardiology, Department of Internal Medicine, Daejeon St. Mary's Hospital, The Catholic University of South Korea (M.-W.P.)
| | - Chan Joon Kim
- Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of South Korea (C.J.K.)
| | - Kiyuk Chang
- Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of South Korea (E.H.C., K.C.)
| | - Thomas Cuisset
- Department of Cardiology, CHU Timone, Marseille, France (T.C.)
| | - Nevio Taglieri
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Byeong-Keuk Kim
- Division of Cardiology, Yonsei University Severance Cardiovascular Hospital, Seoul, South Korea (B.-K.K.)
| | - Yangsoo Jang
- Department of Cardiology, CHA Bundang Medical Center, CHA University College of Medicine, Seongnam, South Korea (Y.J.)
| | - Elena Nardi
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Francesco Saia
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Matheusz Orzalkiewicz
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Francesco Chietera
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Gabriele Ghetti
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Nazzareno Galiè
- Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy (T.P., A.G.B., N.T., E.N., F.S., M.O., F.C., G.G., N.G.)
| | - Gregg W Stone
- Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.W.S.)
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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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Matsuura Y, Moribayashi K, Kaikita K. Optimal Antithrombotic Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Focused Review on High Bleeding Risk. J Atheroscler Thromb 2022; 29:1409-1420. [PMID: 35934784 PMCID: PMC9529379 DOI: 10.5551/jat.rv17066] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2022] [Accepted: 06/08/2022] [Indexed: 11/11/2022] Open
Abstract
Dual antiplatelet therapy (DAPT) is a therapeutic cornerstone to prevent stent thrombosis following percutaneous coronary intervention (PCI) for coronary artery disease (CAD). However, the longer the DAPT duration, the higher the incidence of bleeding and mortality. Since the advent of second-generation drug-eluting stents (DES), the continuous evolution of DES has reduced the thrombotic risk and allowed for a shorter DAPT duration. On the other hand, concerns on the elevated risk of bleeding during antithrombotic therapy have been further raised due to the growing number of elderly CAD patients with multiple comorbidities. The consequent debate topic over post-PCI antithrombotic therapy has shifted from simply reducing thrombotic risk to safely minimizing bleeding risk. Due to the significant impact of bleeding on clinical outcomes, including prognosis, current guidelines on antithrombotic therapy for CAD prioritize stratification of patients at a high bleeding risk (HBR) as the top consideration in determining post-PCI antithrombotic therapy. Achieving optimal antithrombotic therapy for each patient undergoing PCI requires a better understanding of the clinical variables constituting the balance of bleeding and thrombotic risk. This review highlights relevant evidence required to optimize antithrombotic therapy for HBR patients undergoing PCI.
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Affiliation(s)
- Yunosuke Matsuura
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
| | - Kohei Moribayashi
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
| | - Koichi Kaikita
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
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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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Nakagawa Y, Kadota K, Nakao K, Shite J, Yokoi H, Kozuma K, Tanabe K, Akasaka T, Shinke T, Ueno T, Hirayama A, Uemura S, Iijima R, Harada A, Kuroda T, Takita A, Murakami Y, Saito S, Nakamura M. Early P2Y 12 Inhibitor Single Antiplatelet Therapy for High-Bleeding Risk Patients After Stenting - PENDULUM Mono 24-Month Analysis. Circ J 2022; 86:1352-1361. [PMID: 35584932 DOI: 10.1253/circj.cj-21-1004] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
BACKGROUND In PENDULUM mono, Japanese patients with high bleeding risk (HBR) received short-term dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with prasugrel after percutaneous coronary intervention (PCI). One-year data from PENDULUM mono showed better outcomes with prasugrel monotherapy after short-term DAPT compared with matched patients in the PENDULUM registry with longer DAPT durations according to guidelines at that time. This study presents 2-year results. METHODS AND RESULTS We compared 24-month data from PENDULUM mono (n=1,107; de-escalation strategy group) and the PENDULUM registry (n=2,273; conventional strategy group); both were multicenter, non-interventional, prospective registry studies, using the inverse probability of treatment weighting (IPTW) method. In the PENDULUM mono group, the cumulative incidence of clinically relevant bleeding (CRB) at 24 months post-PCI (primary endpoint) was 6.8%, and that of major adverse cardiac and cerebrovascular events (MACCE) was 8.9%. After IPTW adjustment, the cumulative incidence of CRB was 5.8% and 7.2% in PENDULUM mono and the PENDULUM registry, respectively (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.57-1.04; P=0.086), and that of MACCE was 8.0% and 9.5%, respectively (HR 0.77; 95% CI 0.59-1.01; P=0.061). CONCLUSIONS Japanese PCI patients with HBR prescribed prasugrel SAPT after short-term DAPT had a lower ischemic event risk than those prescribed long-term DAPT, and this was particularly relevant for ischemic events after 1 year.
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Affiliation(s)
- Yoshihisa Nakagawa
- Department of Cardiovascular Medicine, Shiga University of Medical Science
| | | | - Koichi Nakao
- Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center
| | - Junya Shite
- Division of Cardiology, Osaka Saiseikai Nakatsu Hospital
| | | | - Ken Kozuma
- Division of Cardiology, Department of Internal Medicine, Teikyo University
| | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital
| | - Takashi Akasaka
- Department of Cardiovascular Medicine, Wakayama Medical University
| | - Toshiro Shinke
- Division of Cardiology, Department of Medicine, Showa University School of Medicine
| | - Takafumi Ueno
- Department of Cardiovascular Medicine, Fukuoka Kinen Hospital
| | | | - Shiro Uemura
- Department of Cardiology, Kawasaki Medical School
| | - Raisuke Iijima
- Division of Cardiovascular Medicine, Toho University Ohashi Medical Center
| | | | - Takeshi Kuroda
- Primary Medical Science Department, Daiichi Sankyo Co., Ltd
| | | | | | - Shigeru Saito
- Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital
| | - Masato Nakamura
- Division of Cardiovascular Medicine, Toho University Ohashi Medical Center
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Okabe K, Miura K, Shima Y, Ikuta A, Taguchi Y, Takahashi K, Osakada K, Ohya M, Kubo S, Tada T, Tanaka H, Fuku Y, Kadota K. Comparison and Validation of Long-Term Bleeding Events for Academic Bleeding Risk (ARC-HBR) Criteria and Contemporary Risk Scores for Percutaneous Coronary Intervention With a Second-Generation Drug Eluting Stent. Circ J 2022; 86:1379-1387. [PMID: 35400715 DOI: 10.1253/circj.cj-21-0901] [Citation(s) in RCA: 3] [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] [Indexed: 09/12/2024]
Abstract
BACKGROUND The Academic Research Consortium for High Bleeding Risk (ARC-HBR) defined a consensus clinical criterion for patients at HBR undergoing percutaneous coronary intervention (PCI). This study aimed to validate and compare the ARC-HBR criteria and the contemporary risk score for long-term bleeding outcomes using a cohort of patients undergoing PCI. METHODS AND RESULTS This study analyzed 3,410 patients who underwent PCI between 2010 and 2013. The endpoint was defined as incidence of The Bleeding Academic Research Consortium 3 or 5 bleeding events. In addition to ARC-HBR, this study validated the predictability of the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score, Patterns of non-adherence to Anti-platelet Regimens In Stented patients (PARIS) bleeding score, and Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) bleeding scores for bleeding events. There was a trend toward an increase in bleeding events, as the risk score increased for all bleeding risk scores used in this study. The ARC-HBR criteria had higher diagnostic sensitivity for bleeding events than other bleeding risk scores. CONCLUSIONS Patients with a higher number of risk factors in each of the four bleeding risk scores had a higher risk of long-term bleeding events. In comparison to other contemporary risk scores, the ARC-HBR criteria were more sensitive in the identification of patients with bleeding events in the long-term.
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Affiliation(s)
- Koya Okabe
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Katsuya Miura
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Yuki Shima
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Akihiro Ikuta
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Yuya Taguchi
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Kotaro Takahashi
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Kohei Osakada
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Masanobu Ohya
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Shunsuke Kubo
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Takeshi Tada
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Hiroyuki Tanaka
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Yasushi Fuku
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Kazushige Kadota
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
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Lee KY, Hwang BH, Lim S, Kim CJ, Choo EH, Lee SH, Kim JJ, Choi IJ, Oh GC, Yang IH, Yoo KD, Chung WS, Ahn Y, Jeong MH, Chang K. Independent Clinical Impacts of Procedural Complexity on Ischemic and Bleeding Events in Patients with Acute Myocardial Infarction: Long-Term Clinical Study. J Clin Med 2022; 11:4853. [PMID: 36013097 PMCID: PMC9410511 DOI: 10.3390/jcm11164853] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2022] [Revised: 08/01/2022] [Accepted: 08/17/2022] [Indexed: 11/16/2022] Open
Abstract
This study aimed to investigate the relationship between a complex percutaneous coronary intervention (C-PCI) and long-term clinical outcomes in the AMI cohort. A total of 10,329 patients were categorized into the C-PCI and non-C-PCI groups. The primary ischemic endpoint was a composite of major adverse cardiac events (MACEs, cardiac death, myocardial infarction, stent thrombosis and revascularization). The primary bleeding endpoint was the risk of overt bleeding (BARC 2, 3 or 5). The median follow-up duration was 4.9 (2.97, 7.16) years. The risks of MACEs and bleeding were significantly higher in the C-PCI group (hazard ratio (HR): 1.72; 95% confidence interval (CI): 1.60 to 1.85; p < 0.001; and HR: 1.32; 95% CI: 1.17 to 1.50; p < 0.001, respectively). After propensity score matching, compared to the non-C-PCI group, the adjusted MACE rate in C-PCI remained significantly higher (p < 0.001), but no significant interaction (p = 0.273) was observed for bleeding. Significant differences in overt bleeding were observed only within the first three months (p = 0.024). The MACEs were consistently higher in the C-PCI group with or without severe comorbid conditions (p < 0.001 for both). Patients with AMI who undergo C-PCI experience worse long-term ischemic outcomes after successful PCI, regardless of the presence of severe comorbidities.
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Affiliation(s)
- Kwan Yong Lee
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
| | - Byung-Hee Hwang
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
| | - Sungmin Lim
- Cardiology Division, Cardiovascular Center, Uijeongbu St. Mary’s Hospital, The Catholic University of Korea, Uijeonbu 11765, Korea
| | - Chan Jun Kim
- Cardiology Division, Cardiovascular Center, Uijeongbu St. Mary’s Hospital, The Catholic University of Korea, Uijeonbu 11765, Korea
| | - Eun-Ho Choo
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
| | - Seung Hoon Lee
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
| | - Jin-Jin Kim
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
| | - Ik Jun Choi
- Cardiology Division, Cardiovascular Center, Incheon St. Mary’s Hospital, The Catholic University of Korea, Incheon 21431, Korea
| | - Gyu Chul Oh
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
| | - In-Ho Yang
- Department of Cardiovascular Medicine, Kyung Hee University Hospital, Seoul 05278, Korea
| | - Ki Dong Yoo
- Cardiology Division, Cardiovascular Center, St. Vincent’s Hospital, The Catholic University of Korea, Suwon 16247, Korea
| | - Wook Sung Chung
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
| | - Youngkeun Ahn
- Department of Cardiology, Cardiovascular Center, Chonnam National University Hospital, Gwangju 61469, Korea
| | - Myung Ho Jeong
- Department of Cardiology, Cardiovascular Center, Chonnam National University Hospital, Gwangju 61469, Korea
| | - Kiyuk Chang
- Cardiology Division, Cardiovascular Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul 06591, Korea
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Rao SV, Ohman EM. Balancing the Risks and Benefits of Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery. JAMA 2022; 328:532-533. [PMID: 35943481 DOI: 10.1001/jama.2022.12444] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Affiliation(s)
- Sunil V Rao
- The Program for Advanced Coronary Disease, Duke Clinical Research Institute, Duke University, Durham, North Carolina
| | - E Magnus Ohman
- The Program for Advanced Coronary Disease, Duke Clinical Research Institute, Duke University, Durham, North Carolina
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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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Lahu S, Bristot P, Gewalt S, Goedel A, Giacoppo D, Schüpke S, Schunkert H, Kastrati A, Sarafoff N. Meta-Analysis of Short vs. Prolonged Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation and Role of Continuation with either Aspirin or a P2Y 12 Inhibitor Thereafter. J Atheroscler Thromb 2022; 29:1001-1019. [PMID: 34248087 PMCID: PMC9252616 DOI: 10.5551/jat.63000] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2021] [Accepted: 06/10/2021] [Indexed: 11/11/2022] Open
Abstract
AIM The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an ongoing debate and novel data has emerged. The aim of this meta-analysis was to assess outcomes of short vs. control DAPT duration. In addition, the role of single antiplatelet therapy (SAPT) after DAPT with either aspirin or P2Y12 inhibitor monotherapy was analyzed. METHODS The authors searched MEDLINE and Cochrane databases and proceedings of international meetings for randomized controlled trials (RCT) comparing ≤ 3 months with ≥ 6 months DAPT after DES implantation. The primary and co-primary outcomes of interest were definite or probable stent thrombosis (ST) and bleeding. In addition, we performed an analysis on studies who continued with either aspirin or P2Y12 monotherapy after DAPT. RESULTS 9 RCTs comprising 41,864 patients were included and we analyzed a short DAPT duration of median 1.5 months vs. 12.1 months in the control group. The risk for ST was similar with short vs. control DAPT duration (0.5 vs. 0.5%; hazard ratio 1.17[95% CI 0.89-1.54]; p=0.26). Bleeding was significantly reduced with short vs. control DAPT duration (1.9 vs. 3.0%; 0.65[0.54-0.77]; p<0.0001).ST was not different between short vs. control DAPT duration in the analysis of the 4 RCTs who continued with aspirin after DAPT and the 5 P2Y12 RCTs, respectively, and no heterogeneity was detected (p=0.861). Bleeding was also reduced with short vs. control DAPT in both the aspirin (1.2 vs. 1.7%; 0.71[0.51-0.99]; p=0.04) and P2Y12 inhibitor studies (2.1 vs. 3.4%; 0.62[0.47-0.80]; p=0.0003) and no heterogeneity was detected (p=0.515). CONCLUSIONS Our meta-analysis shows that short DAPT ≤ 3 months followed by SAPT reduces bleeding and is not associated with an increase in ST. The results were consistent within the aspirin and P2Y12 SAPT studies.
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Affiliation(s)
- Shqipdona Lahu
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
| | - Peter Bristot
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
| | - Senta Gewalt
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
| | - Alexander Goedel
- Klinik und Poliklinik fuer Innere Medizin I, Klinikum rechts der Isar, Technische Universitaet Munich, Germany
| | - Daniele Giacoppo
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
| | - Stefanie Schüpke
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
| | - Heribert Schunkert
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
- Deutsches Zentrum fuer Herz- und Kreislauferkrankungen (DZHK), Partner Site Munich Heart Alliance, Munich, Germany
| | - Adnan Kastrati
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
- Deutsches Zentrum fuer Herz- und Kreislauferkrankungen (DZHK), Partner Site Munich Heart Alliance, Munich, Germany
| | - Nikolaus Sarafoff
- Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Munich, Technische Universitaet Muenchen, Munich, Germany
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Vranken NPA, Rasoul S, Luijkx JJP, Pustjens TFS, Postma S, Kolkman EJ, Kedhi E, Rifqi S, Lee MKY, Ebelt H, Merkely B, Verdoia M, Wojakowski W, van ’t Hof AAWJ, Suryapranata H, De Luca G. Short-term dual antiplatelet therapy in diabetic patients admitted for acute coronary syndrome treated with a new-generation drug-eluting stent. Diabetes Metab Res Rev 2022; 38:e3530. [PMID: 35395144 PMCID: PMC9541907 DOI: 10.1002/dmrr.3530] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/17/2021] [Revised: 02/07/2022] [Accepted: 03/09/2022] [Indexed: 12/01/2022]
Abstract
BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug-eluting stent (DES) remains unclear. This is a prespecified sub-study from the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short-term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent. METHODS In this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow-up. RESULTS A total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow-up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups. CONCLUSIONS This sub-analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high-risk patients.
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Affiliation(s)
| | - Saman Rasoul
- Department of CardiologyZuyderland Medical CentreHeerlenThe Netherlands
| | | | | | | | | | - Elvin Kedhi
- Department of CardiologyErasmus HospitalBrusselsBelgium
| | - Sodiqur Rifqi
- Department of CardiologyDr. Kariadi HospitalSemarangIndonesia
| | | | - Henning Ebelt
- Department of CardiologyCatholic Hospital of Johann NepomukErfurtGermany
| | - Béla Merkely
- Department of CardiologySemmelweis University Heart and Vascular CenterBudapestHungary
| | - Monica Verdoia
- Division of CardiologyOspedale degli Infermi, ASL BiellaBiellaItaly
- Division of Clinical and Experimental CardiologyAOU Sassari, University of SassariSassariItaly
| | | | - Arnoud A. W. J. van ’t Hof
- Department of CardiologyZuyderland Medical CentreHeerlenThe Netherlands
- Department of CardiologyIsalaZwolleThe Netherlands
| | - Harry Suryapranata
- Department of CardiologyRadboud University Medical CentreNijmegenThe Netherlands
| | - Giuseppe De Luca
- Division of Clinical and Experimental CardiologyAOU Sassari, University of SassariSassariItaly
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Song S, Gong S, Lei T, Tian H, Lu T, Lei C, Jin H, Yang W, Yang K, Guo T. Comparative efficacy and safety of local palliative therapeutics for unresectable malignant biliary obstruction: a Bayesian network meta-analysis. Expert Rev Gastroenterol Hepatol 2022; 16:555-567. [PMID: 35639826 DOI: 10.1080/17474124.2022.2085090] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
BACKGROUND Both radiofrequency ablation (RFA), photodynamic therapy (PDT), and biliary stent alone are common local palliative therapies for unresectable malignant biliary obstruction (MBO), but the best modality is uncertain. RESEARCH DESIGN AND METHODS Embase, Cochrane Library, PubMed, and Web of Science were systematically searched up to 30 January 2022, for eligible studies that compared either two or all modalities in unresectable MBO. RESULTS Thirty-three studies with 2974 patients were included in this study. The PDT+Stent and RFA+Stent groups had better overall survival and longer mean survival time than Stent alone (all P < 0.05). Moreover, patients with RFA+Stent demonstrated better mean duration of stent patency (MD: 2.0, 95%CI,1.1 to 2.8, P < 0.05) than Stent alone. The three modalities had similar postoperative mild bleeding, cholangitis, and pancreatitis (all P ≥ 0.05). According to network ranking, PDT+Stent was most likely to provide better survival, RFA+Stent was most likely to maintain stent patency. CONCLUSIONS RFA or PDT plus biliary stent is effective and safe local palliative therapy for unresectable MBO, but the current studies cannot absolutely determine which modality is the best. We should offer patients the most appropriate treatment according to the advantage of each therapy and the patient's performance status.
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Affiliation(s)
- Shaoming Song
- Department of Clinical Medicine, the First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China.,Department of General Surgery, Gansu Provincial Hospital, Lanzhou, Gansu, China.,Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China
| | - Shiyi Gong
- Department of General Surgery, Gansu Provincial Hospital, Lanzhou, Gansu, China.,Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou, Gansu, China
| | - Ting Lei
- Department of Clinical Medicine, the First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China.,Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China
| | - Hongwei Tian
- Department of Clinical Medicine, the First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China.,Department of General Surgery, Gansu Provincial Hospital, Lanzhou, Gansu, China.,Key Laboratory of Molecular Diagnosis and Precision Therapy of Surgical Tumors of Gansu Province, Lanzhou, Gansu, China
| | - Tingting Lu
- Department of General Surgery, Gansu Provincial Hospital, Lanzhou, Gansu, China.,Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou, Gansu, China
| | - Caining Lei
- Department of General Surgery, Gansu Provincial Hospital, Lanzhou, Gansu, China
| | - Haojie Jin
- Department of Clinical Medicine, the First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China.,Department of General Surgery, Gansu Provincial Hospital, Lanzhou, Gansu, China.,Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China
| | - Wenwen Yang
- Department of Clinical Medicine, the First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China.,Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China
| | - Kehu Yang
- Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China
| | - Tiankang Guo
- Department of Clinical Medicine, the First Clinical Medical College of Lanzhou University, Lanzhou, Gansu, China
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Jourdi G, Marquis-Gravel G, Martin AC, Lordkipanidzé M, Godier A, Gaussem P. Antiplatelet Therapy in Atherothrombotic Diseases: Similarities and Differences Across Guidelines. Front Pharmacol 2022; 13:878416. [PMID: 35571090 PMCID: PMC9092185 DOI: 10.3389/fphar.2022.878416] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2022] [Accepted: 03/29/2022] [Indexed: 12/24/2022] Open
Abstract
Antiplatelet therapy, mainly consisting of aspirin and P2Y12 receptor antagonists, is the cornerstone of the pharmacological treatment and prevention of atherothrombotic diseases. Its use, especially in secondary cardiovascular prevention, has significantly improved patient clinical outcomes in the last decades. Primary safety endpoint (i.e., bleeding complications) remain a major drawback of antiplatelet drugs. National and international societies have published and regularly updated guidelines for antiplatelet therapy aiming to provide clinicians with practical recommendations for a better handling of these drugs in various clinical settings. Many recommendations find common ground between international guidelines, but certain strategies vary across the countries, particularly with regard to the choice of molecules, dosage, and treatment duration. In this review, we detail and discuss the main antiplatelet therapy indications in the light of the different published guidelines and the significant number of recently published clinical trials and meta-analyses and highlight the areas that deserve further investigation in order to improve antiplatelet therapy in patients with atherothrombotic diseases.
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Affiliation(s)
- Georges Jourdi
- Research Center, Montreal Heart Institute, Montreal, QC, Canada.,Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada
| | - Guillaume Marquis-Gravel
- Research Center, Montreal Heart Institute, Montreal, QC, Canada.,Faculty of Medicine, Université de Montréal, Montreal, QC, Canada
| | - Anne-Céline Martin
- Université Paris Cité, INSERM, Innovative Therapies in Haemostasis, Paris, France.,Service de Cardiologie, AP-HP, Hôpital Européen Georges Pompidou, Paris, France
| | - Marie Lordkipanidzé
- Research Center, Montreal Heart Institute, Montreal, QC, Canada.,Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada
| | - Anne Godier
- Université Paris Cité, INSERM, Innovative Therapies in Haemostasis, Paris, France.,Service d'Anesthésie Réanimation, AP-HP, Hôpital Européen Georges Pompidou, Paris, France
| | - Pascale Gaussem
- Université Paris Cité, INSERM, Innovative Therapies in Haemostasis, Paris, France.,Service d'Hématologie Biologique, AP-HP, Hôpital Européen Georges Pompidou, Paris, France
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45
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Costa JR, Goel R, Meneguz‐Moreno RA, Abizaid AA. Novel Drug‐Eluting Stent Systems. Interv Cardiol 2022. [DOI: 10.1002/9781119697367.ch36] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022] Open
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46
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Song YB. De-escalation strategies of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention for acute coronary syndrome. CARDIOVASCULAR PREVENTION AND PHARMACOTHERAPY 2022; 4:63-69. [DOI: 10.36011/cpp.2022.4.e11] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/04/2022] [Accepted: 04/13/2022] [Indexed: 09/01/2023]
Abstract
Antiplatelet therapy is important for reducing systemic and local thrombotic events in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). Antiplatelet treatment regimens, along with dual antiplatelet therapy consisting of aspirin and a P2Y12 inhibitor for patients receiving PCI, have frequently changed over the years. With improvements in the understanding of the prognostic relevance of bleeding events in patients with PCI, as well as the safety and efficacy of drug-eluting stents, several randomized controlled trials (RCTs) have been conducted on antiplatelet treatment strategies associated with a more favorable balance between ischemic and bleeding risks. Several key RCTs for appropriate antiplatelet therapy in patients receiving PCI for ACS have been reported, and practical guidelines have been updated. This manuscript presents the results of major RCTs on de-escalation strategies of dual antiplatelet treatment in patients receiving PCI for ACS.
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47
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Moribayashi K, Matsuura Y, Kaikita K. Stratifying Bleeding Risk and Beyond - Predicting Where Bleeding Will Occur. Circ J 2022; 86:784-786. [PMID: 35283369 DOI: 10.1253/circj.cj-22-0091] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/19/2024]
Affiliation(s)
- Kohei Moribayashi
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
| | - Yunosuke Matsuura
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
| | - Koichi Kaikita
- Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
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Banning AP, Serruys P, De Maria GL, Ryan N, Walsh S, Gonzalo N, Jan van Geuns R, Onuma Y, Sabate M, Davies J, Lesiak M, Moreno R, Cruz-Gonzalez I, Hoole SP, Piek JJ, Appleby C, Fath-Ordoubadi F, Zaman A, Van Mieghem NM, Uren N, Zueco J, Buszman P, Iniguez A, Goicolea J, Hildick-Smith D, Ochala A, Dudek D, de Vries T, Taggart D, Farooq V, Spitzer E, Tijssen J, Escaned J. Five-year outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: final results of the SYNTAX II study. Eur Heart J 2022; 43:1307-1316. [PMID: 34617993 PMCID: PMC8970987 DOI: 10.1093/eurheartj/ehab703] [Citation(s) in RCA: 67] [Impact Index Per Article: 22.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/09/2021] [Revised: 08/24/2021] [Accepted: 09/14/2021] [Indexed: 11/14/2022] Open
Abstract
AIMS The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. METHODS AND RESULTS SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events' outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). CONCLUSIONS Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.
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Affiliation(s)
- Adrian P Banning
- Department of Cardiology, John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Oxford OX3 9DU, UK
| | - Patrick Serruys
- Department of Cardiology, National University of Ireland, Galway, Ireland
| | - Giovanni Luigi De Maria
- Department of Cardiology, John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Oxford OX3 9DU, UK
| | - Nicola Ryan
- Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid 28040, Spain
| | - Simon Walsh
- Department of Cardiology, Belfast Health & Social Care Trust, Belfast BT8*BH, UK
| | - Nieves Gonzalo
- Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid 28040, Spain
| | | | - Yoshinobu Onuma
- Department of Cardiology, National University of Ireland, Galway, Ireland
| | - Manel Sabate
- Cardiovascular Institute, Hospital Clinic I Provincial de Barcelona, IDIBAPS, Centro de Investigación Biomédica en Red. Enfermedades Cardiovasculares (CIBERCV) CB16/11/00411, Barcelona Spain
| | - Justin Davies
- Department of Cardiology, Imperial College London, Kensington, London SW7 2AZ, UK
| | - Maciej Lesiak
- 1st Department of Cardiology, University of Medical Sciences, Poznan 61-701, Poland
| | - Raul Moreno
- Department of Cardiology, Hospital Universitario la Paz, Paseo de la Castellana, 261, Madrid 28046, Spain
| | - Ignacio Cruz-Gonzalez
- Department of Cardiology, Hospital Universitario de Salamanca, IBSAL, Paseo de San Vicente, 58, Salamanca 37007, Spain
| | - Stephen P Hoole
- Department of Cardiology, Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge CB23 3RE, UK
| | - Jan J Piek
- Department of Cardiology, Academic Medical Center of Amsterdam, Amsterdam 1105 AZ, The Netherlands
| | - Clare Appleby
- Liverpool Heart and Chest Hospital, Thomas Dr, Liverpool L14 3PE, UK
| | - Farzin Fath-Ordoubadi
- Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Oxford Rd, Manchester M13 9WL, UK
| | - Azfar Zaman
- Department of Cardiology, Freeman Hospital and Newcastle University, High Heaton, Newcastle upon Tyne NE7 7DN, UK
| | - Nicolas M Van Mieghem
- Department of Cardiology, Thoraxcenter, Erasmus MC, ’s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands
| | - Neal Uren
- Department of Cardiology, The Royal Infirmary of Edinburgh, 51 Little France Dr, Edinburgh EH16 4SA, UK
| | - Javier Zueco
- Department of Cardiology, Hospital Universitario Valdecilla, Av. Valdecilla, 25, Santander, Cantabria 39008, Spain
| | - Pawel Buszman
- Department of Cardiology, American Heart of Poland (PAK), Sanatoryjna 1, Ustron 43-450, Poland
| | - Andres Iniguez
- Department of Cardiology, Hospital Álvaro Cunqueiro, c/Clara Campoamor 341, Vigo 36213, Spain
| | - Javier Goicolea
- Department of Cardiology, Hospital Puerta de Hierro, C. Joaquín Rodrigo, 1, Majadahonda 28222, Madrid, Spain
| | - David Hildick-Smith
- Department of Cardiology, Brighton & Sussex University Hospitals NHS Trust, Barry Building, Eastern Rd, Brighton BN2 5BE, UK
| | - Andrzej Ochala
- Department of Cardiology, Gornoslaskie Centrum Medycnze, 45/47, Katowice 40-635, Poland
| | - Dariusz Dudek
- Department of Interventional Cardiology, Jagiellonian University, Gołe, bia 24, Krakow 31-007, Poland
| | - Ton de Vries
- Cardialysis BV, Westblaak 98, 3012 KM Rotterdam, The Netherlands
| | - David Taggart
- Department of Cardiology, John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Oxford OX3 9DU, UK
| | - Vasim Farooq
- Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Oxford Rd, Manchester M13 9WL, UK
| | - Ernest Spitzer
- Cardialysis BV, Westblaak 98, 3012 KM Rotterdam, The Netherlands
- European Cardiovascular Research Institute, Westblaak 98, 3012 KM Rotterdam, The Netherlands
| | - Jan Tijssen
- European Cardiovascular Research Institute, Westblaak 98, 3012 KM Rotterdam, The Netherlands
| | - Javier Escaned
- Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid 28040, Spain
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Antiplatelet therapy after percutaneous coronary intervention: current status and future perspectives. Cardiovasc Interv Ther 2022; 37:255-263. [PMID: 35237927 DOI: 10.1007/s12928-022-00847-1] [Citation(s) in RCA: 28] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2022] [Accepted: 02/03/2022] [Indexed: 12/12/2022]
Abstract
Antiplatelet therapy after percutaneous coronary intervention (PCI) has been changing in parallel with the development of drug-eluting stents (DES) and antiplatelet agents. The recommendation of dual antiplatelet therapy duration is getting shorter due to the decreased risk of stent thrombosis in new-generation DES, the use of a P2Y12 inhibitor as a monotherapy, and the increasing prevalence of high bleeding risk patients. Antithrombotic therapy after PCI has also changed due to the introduction of direct oral anticoagulants. Aspirin-free P2Y12 inhibitor monotherapy is now being evaluated in several prospective studies as a novel strategy of antiplatelet therapy after PCI. This review shows a current status and provides future perspectives for the antiplatelet therapy after PCI.
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50
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Outcomes of prolonged dual anti-platelet therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A nationwide registry-based study. Am Heart J 2022; 245:81-89. [PMID: 34902311 DOI: 10.1016/j.ahj.2021.11.018] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/12/2021] [Revised: 09/29/2021] [Accepted: 11/20/2021] [Indexed: 11/23/2022]
Abstract
BACKGROUND Randomized controlled trials have shown a reduced risk of ischemic events and an increased risk of bleeding in patients treated with prolonged dual anti-platelet therapy (DAPT) beyond 12 months following acute coronary syndrome (ACS). We aimed to investigate outcomes of prolonged DAPT vs aspirin monotherapy (ASA) in a real-world population. METHODS AND RESULTS Using nationwide registries, we identified all patients with ACS who underwent percutaneous coronary intervention and received 12-month DAPT between January 2013 and October 2016. Patients still on DAPT were compared to patients on ASA at index date (15 months after ACS-date) and followed for up to 2 years. Cox regression models were employed to calculate standardized risks of all-cause mortality, major adverse cardiovascular event (MACE), and major bleeding. The study included 7,449 patients, 1,901 on DAPT (median age 66, 72.1% male) and 5,548 on ASA (median age 65, 75.1% male). Standardized absolute 2-year risk of all-cause mortality, MACE, and major bleeding was 2.7%, 3.7%, and 5.4% for DAPT vs 2.2%, 3.8%, and 1.3% for ASA. DAPT was not associated with a significant standardized 2-year risk difference (SRD) of all-cause mortality (SRD: 0.5%, 95% confidence interval [CI]: -0.9 to 1.7) or MACE (SRD: -0.1%, 95% CI -1.8 to 1.6), but a significantly higher risk of major bleeding (SRD: 4.1%, 95% CI 1.8-6.6). CONCLUSIONS In a nationwide cohort of ACS patients undergoing percutaneous coronary intervention, prolonged DAPT was not significantly associated with a reduced risk of all-cause mortality or MACE, but an increased risk of major bleeding. Future randomized controlled trials should investigate the optimal anti-platelet regimen in this patient group.
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