|
1
|
Chen J, Zhou C, Fang W, Yin J, Shi J, Ge J, Shen L, Liu SM, Liu SJ. Identification of endothelial protein C receptor as a novel druggable agonistic target for reendothelialization promotion and thrombosis prevention of eluting stent. Bioact Mater 2024; 41:485-498. [PMID: 39210965 PMCID: PMC11359769 DOI: 10.1016/j.bioactmat.2024.07.028] [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: 03/27/2024] [Revised: 07/16/2024] [Accepted: 07/21/2024] [Indexed: 09/04/2024] Open
Abstract
The commercially available drug-eluting stent with limus (rapamycin, everolimus, etc.) or paclitaxel inhibits smooth muscle cell (SMC), reducing the in-stent restenosis, whereas damages endothelial cell (EC) and delays stent reendothelialization, increasing the risk of stent thrombosis (ST) and sudden cardiac death. Here we present a new strategy for promoting stent reendothelialization and preventing ST by exploring the application of precise molecular targets with EC specificity. Proteomics was used to investigate the molecular mechanism of EC injury caused by rapamycin. Endothelial protein C receptor (EPCR) was screened out as a crucial EC-specific effector. Limus and paclitaxel repressed the EPCR expression, while overexpression of EPCR protected EC from coating (eluting) drug-induced injury. Furthermore, the ligand activated protein C (APC), polypeptide TR47, and compound parmodulin 2, which activated the target EPCR, promoted EC functions and inhibited platelet or neutrophil adhesion, and enhanced rapamycin stent reendothelialization in the simulated stent environment and in vitro. In vivo, the APC/rapamycin-coating promoted reendothelialization rapidly and prevented ST more effectively than rapamycin-coating alone, in both traditional metal stents and biodegradable stents. Additionally, overexpression or activation of the target EPCR did not affect the cellular behavior of SMC or the inhibitory effect of rapamycin on SMC. In conclusion, EPCR is a promising therapeutical agonistic target for pro-reendothelialization and anti-thrombosis of eluting stent. Activation of EPCR protects against coating drugs-induced EC injury, inflammatory cell, or platelet adhesion onto the stent. The novel application formula for APC/rapamycin-combined eluting promotes stent reendothelialization and prevents ST.
Collapse
Affiliation(s)
- Jing Chen
- Guangzhou Institute of Cardiovascular Disease, Guangdong Key Laboratory of Vascular Diseases, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, 510260, PR China
- Department of Cardiology, The First Affliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, 510000, PR China
| | - Changyi Zhou
- Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, PR China
- Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Fudan University, Shanghai, 200433, PR China
| | - Weilun Fang
- Guangzhou Institute of Cardiovascular Disease, Guangdong Key Laboratory of Vascular Diseases, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, 510260, PR China
| | - Jiasheng Yin
- Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, PR China
- Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Fudan University, Shanghai, 200433, PR China
| | - Jian Shi
- Guangzhou Institute of Cardiovascular Disease, Guangdong Key Laboratory of Vascular Diseases, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, 510260, PR China
| | - Junbo Ge
- Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, PR China
- Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Fudan University, Shanghai, 200433, PR China
| | - Li Shen
- Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, PR China
- Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Fudan University, Shanghai, 200433, PR China
| | - Shi-Ming Liu
- Guangzhou Institute of Cardiovascular Disease, Guangdong Key Laboratory of Vascular Diseases, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, 510260, PR China
- Department of Cardiology, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, 510260, PR China
| | - Shao-Jun Liu
- Guangzhou Institute of Cardiovascular Disease, Guangdong Key Laboratory of Vascular Diseases, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, 510260, PR China
| |
Collapse
|
|
2
|
Sheng X, Yang G, Zhang Q, Zhou Y, Pu J. Impact of risk factors on intervened and non-intervened coronary lesions. AMERICAN JOURNAL OF CARDIOVASCULAR DISEASE 2024; 14:255-266. [PMID: 39309112 PMCID: PMC11410792 DOI: 10.62347/xtbg3549] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/26/2024] [Accepted: 08/21/2024] [Indexed: 09/25/2024]
Abstract
INTRODUCTION In-stent restenosis (ISR) and aggravated non-intervened coronary lesions (ANL) are two pivotal aspects of disease progression in patients with coronary artery disease (CAD). Established risk factors for both include hyperlipidemia, hypertension, diabetes, chronic kidney disease, and smoking. However, there is limited research on the comparative risk factors for the progression of these two aspects of progression. The aim of this study was to analyze and compare the different impacts of identical risk factors on ISR and ANL. METHODS This study enrolled a total of 510 patients with multiple coronary artery lesions who underwent repeated coronary angiography (CAG). All patients had previously undergone percutaneous coronary intervention (PCI) and presented non-intervened coronary lesions in addition to the previously intervened vessels. RESULTS After data analysis, it was determined that HbA1c (OR 1.229, 95% CI 1.022-1.477, P=0.028) and UA (OR 1.003, 95% CI 1.000-1.005, P=0.024) were identified as independent risk factors for ISR. Furthermore, HbA1c (OR 1.215, 95% CI 1.010-1.460, P=0.039), Scr (OR 1.007, 95% CI 1.003-1.017, P=0.009), and ApoB (OR 1.017, 95% CI 1.006-1.029, P=0.004) were identified as independent risk factors for ANL. The distribution of multiple blood lipid levels differed between the ANL only group and the ISR only group. Non-HDL-C (2.17 mmol/L vs. 2.44 mmol/L, P=0.007) and ApoB (63.5 mg/dL vs. 71.0 mg/dL, P=0.011) exhibited significantly higher values in the ANL only group compared to the ISR only group. CONCLUSIONS Blood glucose levels and chronic kidney disease were identified as independent risk factors for both ISR and ANL, while elevated lipid levels were only significantly associated with ANL. In patients with non-intervened coronary lesions following PCI, it is crucial to assess the concentration of non-HDL-C and ApoB as they serve as significant risk factors.
Collapse
Affiliation(s)
- Xincheng Sheng
- Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University 160 Pu Jian Road, Shanghai 200127, China
| | - Gan Yang
- Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University 160 Pu Jian Road, Shanghai 200127, China
| | - Qing Zhang
- Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University 160 Pu Jian Road, Shanghai 200127, China
| | - Yong Zhou
- Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University 160 Pu Jian Road, Shanghai 200127, China
| | - Jun Pu
- Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University 160 Pu Jian Road, Shanghai 200127, China
| |
Collapse
|
|
3
|
Hassan A, Amin AM, Gadelmawla AF, Mansour A, Mostafa HA, Desouki MT, Naguib MM, Ali B, Siraj A, Suppah M, Hakim D. Comparative effectiveness of ultrathin vs. standard strut drug-eluting stents: insights from a large-scale meta-analysis with extended follow-up. Eur J Med Res 2024; 29:388. [PMID: 39068447 PMCID: PMC11282633 DOI: 10.1186/s40001-024-01949-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2024] [Accepted: 06/24/2024] [Indexed: 07/30/2024] Open
Abstract
BACKGROUND Newer generation ultrathin strut stents are associated with less incidence of target lesion failure (TLF) in patients undergoing percutaneous coronary intervention (PCI) in the short term. However, its long-term effect on different cardiovascular outcomes remains unknown. OBJECTIVES We aim to identify the effects of newer-generation ultrathin-strut stents vs. standard thickness second-generation drug-eluting stents (DES) on long-term outcomes of revascularization in coronary artery disease. METHODS We searched PubMed, Web of Science, Cochrane Library databases, and Scopus for randomized controlled trials (RCTs) and registries that compare newer-generation ultrathin-strut (< 70 mm) with thicker strut (> 70 mm) DES to evaluate cardioprotective effects over a period of up to 5 years. Primary outcome was TLF, a composite of cardiac death, target vessel myocardial infarction (TVMI) or target lesion revascularization (TLR). Secondary outcomes included the components of TLF, stent thrombosis (ST), and all-cause death were pooled as the standardized mean difference between the two groups from baseline to endpoint. RESULTS We included 19 RCTs and two prospective registries (103,101 patients) in this analysis. The overall effect on the primary outcome was in favor of second-generation ultrathin struts stents in terms of TLF at ≥ 1 year, ≥ 2 years, and ≥ 3 years (P value = 0.01, 95% CI [0.75, 0.96]), P value = 0.003, 95% CI [0.77, 0.95]), P value = 0.007, 95% CI [0.76, 0.96]), respectively. However, there was no reported benefit in terms of TLF when we compared the two groups at ≥ 5 years (P value = 0.21), 95% CI [0.85, 1.04]). Some of the reported components of the primary and secondary outcomes, such as TLR, target vessel revascularization (TVR), and TVMI, showed the same pattern as the TLF outcome. CONCLUSION Ultrathin-strut DES showed a beneficial effect over thicker strut stents for up to 3 years. However, at the 5-year follow-up, the ultrathin strut did not differ in terms of TLF, TLR, TVR, and TVMI compared with standard-thickness DES, with similar risks of patient-oriented composite endpoint (POCE), MI, ST, cardiac death, and all-cause mortality.
Collapse
Affiliation(s)
- Ahmed Hassan
- Faculty of Medicine, October 6 University, Giza, Egypt.
- Department of Cardiology, Suez Medical Complex, Ministry of Health and Population, Suez, Egypt.
| | | | | | - Ahmed Mansour
- Faculty of Medicine, Al-Azhar University, Cairo, Egypt
| | | | | | | | - Bilal Ali
- University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
| | - Aisha Siraj
- MetroHealth Medical Center, Case Western Reserve University, Cleveland Heights, OH, USA
| | - Mustafa Suppah
- Department of Cardiovascular Medicine, Mayo Clinic, Arizona, USA
| | - Diaa Hakim
- Department of Cardiology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt
| |
Collapse
|
|
4
|
Pingili A, Rao SJ, Khalid T, Wang J, Kaliyadan A. "Very" Very Late Stent Thrombosis: A Detailed Look at Two Cases. Cureus 2024; 16:e61914. [PMID: 38978940 PMCID: PMC11230619 DOI: 10.7759/cureus.61914] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/07/2024] [Indexed: 07/10/2024] Open
Abstract
Although percutaneous coronary intervention (PCI) has radically transformed the scope of treating coronary artery disease with stenting, stent thrombosis (STh) remains a feared complication. Very late STh, a rare complication after PCI, refers to STh occurring greater than one year after post-stent implantation. An even rarer phenomenon, "very" very late stent thrombosis (VVLST), is described in the literature as STh occurring more than five years post-stent implantation. To our knowledge, there are only 10 case reports and one case series describing VVLST. We discuss two additional complex clinical cases of VVLST presenting as ST-elevation myocardial infarction. We highlight epidemiology, pathophysiology, presentation, diagnostic methods, treatment approach, associated complications, and the need for more extensive future work to minimize the risk of VVLST.
Collapse
Affiliation(s)
- Adhvithi Pingili
- Internal Medicine, MedStar Union Memorial Hospital, Baltimore, USA
| | - Shiavax J Rao
- Internal Medicine, MedStar Union Memorial Hospital, Baltimore, USA
| | - Taha Khalid
- Hospital Medicine, St. Mary's Medical Center, Huntington, USA
| | - John Wang
- Interventional Cardiology, MedStar Union Memorial Hospital, Baltimore, USA
| | - Antony Kaliyadan
- Interventional Cardiology, MedStar Union Memorial Hospital, Baltimore, USA
| |
Collapse
|
|
5
|
Nishiura N, Kubo S, Fujii C, Shima Y, Ikuta A, Osakada K, Tada T, Fuku Y, Tanaka H, Kadota K. Fifteen-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation. Circ J 2024; 88:938-943. [PMID: 38267035 DOI: 10.1253/circj.cj-23-0929] [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: 01/26/2024]
Abstract
BACKGROUND Clinical outcomes after percutaneous coronary intervention have improved with the use of drug-eluting stents, but data beyond 10 years are limited. The purpose of this study was to evaluate the clinical outcomes of patients undergoing sirolimus-eluting stent implantation with follow-up beyond 10 years and to determine the impact of clinical and angiographic characteristics on long-term prognosis. METHODS AND RESULTS The clinical outcomes of 885 patients who had undergone sirolimus-eluting stent implantation at a single institution were retrospectively reviewed. Primary endpoints included in the analysis were clinically driven target lesion revascularization (cTLR) and target lesion revascularization (TLR). Univariate and multivariate nominal logistic regression was used for data analysis. The incidence rates of cTLR and TLR beyond 10 years after sirolimus-eluting stent implantation were 16.4% and 36.8%, respectively, with cTLR tending to decrease beyond 10 years. Acute coronary syndrome was a predominant trigger for cTLR. Age, statin use, and stent restenosis emerged as predictors of cTLR within 10 years, but no significant predictors other than age were identified beyond 10 years. CONCLUSIONS Events continue to occur beyond 10 years after sirolimus-eluting stent implantation, with a trend toward an increase in acute coronary syndromes. It is important to be vigilant about the occurrence of acute coronary syndromes during long-term follow-up.
Collapse
Affiliation(s)
- Naoki Nishiura
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Shunsuke Kubo
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Chihiro Fujii
- Department of Internal Medicine, Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
| | - Yuki Shima
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Akihiro Ikuta
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Kohei Osakada
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Takeshi Tada
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Yasushi Fuku
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Hiroyuki Tanaka
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| | - Kazushige Kadota
- Department of Cardiovascular Medicine, Kurashiki Central Hospital
| |
Collapse
|
|
6
|
Zeng Y, Xu J, Deng Y, Li X, Chen W, Tang Y. Drug-eluting stents for coronary artery disease in the perspective of bibliometric analysis. Front Cardiovasc Med 2024; 11:1288659. [PMID: 38440210 PMCID: PMC10910058 DOI: 10.3389/fcvm.2024.1288659] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2023] [Accepted: 01/30/2024] [Indexed: 03/06/2024] Open
Abstract
Drug-eluting stents (DES) play a crucial role in treating coronary artery disease (CAD) by preventing restenosis. These stents are coated with drug carriers that release antiproliferative drugs within the vessel. Over the past two decades, DES have been employed in clinical practice using various materials, polymers, and drug types. Despite optimizations in their design and materials to enhance biocompatibility and antithrombotic properties, evaluating their long-term efficacy and safety necessitates improved clinical follow-up and monitoring. To delineate future research directions, this study employs a bibliometric analysis approach. We comprehensively surveyed two decades' worth of literature on DES for CAD using the Web of Science Core Collection (WOSCC). Out of 5,778 articles, we meticulously screened them based on predefined inclusion and exclusion criteria. Subsequently, we conducted an in-depth analysis encompassing annual publication trends, authorship affiliations, journal affiliations, keywords, and more. Employing tools such as Excel 2021, CiteSpace 6.2R3, VOSviewer 1.6.19, and Pajek 5.17, we harnessed bibliometric methods to derive insights from this corpus. Analysis of annual publication data indicates a recent stabilisation or even a downward trend in research output in this area. The United States emerged as the leading contributor, with Columbia University and CRF at the forefront in both publication output and citation impact. The most cited document pertained to standardized definitions for clinical endpoints in coronary stent trials. Our author analysis identifies Patrick W. Serruys as the most prolific contributor, underscoring a dynamic exchange of knowledge within the field.Moreover, the dual chart overlay illustrates a close interrelation between journals in the "Medicine," "Medical," and "Clinical" domains and those in "Health," "Nursing," and "Medicine." Frequently recurring keywords in this research landscape include DES coronary artery disease, percutaneous coronary intervention, implantation, and restenosis. This study presents a comprehensive panorama encompassing countries, research institutions, journals, keyword distributions, and contributions within the realm of DES therapy for CAD. By highlighting keywords exhibiting recent surges in frequency, we elucidate current research hotspots and frontiers, thereby furnishing novel insights to guide future researchers in this evolving field.
Collapse
Affiliation(s)
- Ying Zeng
- Jiangxi Medical College, Nanchang University, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, China
| | - Jiawei Xu
- Jiangxi Medical College, Nanchang University, Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, China
| | - Yuxuan Deng
- Department of Endocrinology and Metabolism, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China
| | - Xiaoxing Li
- The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China
| | - Wen Chen
- Jiangxi Cancer Hospital, Nanchang, China
| | - Yu Tang
- Jiangxi Provincial People's Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, China
| |
Collapse
|
|
7
|
Tran HD, Pham HVT, Vu TD. "Very" Very Late Stent Thrombosis: The Occurrence of Thrombosis 12.3 Years After Paclitaxel-Eluting Stent Implantation. Cureus 2024; 16:e53010. [PMID: 38410290 PMCID: PMC10894723 DOI: 10.7759/cureus.53010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 01/25/2024] [Indexed: 02/28/2024] Open
Abstract
Very late stent thrombosis (VLST) refers to stent thrombosis occurring beyond one year after coronary intervention. "Very" very or extremely late stent thrombosis (VVLST), occurring after five years of drug-eluting stent (DES) implantation, is extremely rare. We report a case of a 60-year-old male patient with ST-elevation myocardial infarction (STEMI) due to in-stent thrombosis 12.3 years after first-generation DES implantation; we also engage in a brief discussion of its pathogenesis and prevention.
Collapse
Affiliation(s)
- Hung D Tran
- Cardiovascular Center, Hospital 103/Vietnam Military Medical University, Hanoi, VNM
| | - Ha V T Pham
- Cardiovascular Center, Hospital 103/Vietnam Military Medical University, Hanoi, VNM
| | - Thang D Vu
- Cardiovascular Center, Hospital 103/Vietnam Military Medical University, Hanoi, VNM
| |
Collapse
|
|
8
|
Shiomi H, Kozuma K, Morimoto T, Kadota K, Tanabe K, Morino Y, Tamura T, Abe M, Suwa S, Ito Y, Kobayashi M, Dai K, Nakao K, Tarutani Y, Taniguchi R, Nishikawa H, Yamamoto Y, Yamasaki T, Okamura A, Nakagawa Y, Ando K, Kobayashi K, Kawai K, Hibi K, Kimura T. Ten-year clinical outcomes from a randomized trial comparing new-generation everolimus-eluting stent versus first-generation Sirolimus-eluting stent: Results from the RESET extended study. Catheter Cardiovasc Interv 2023; 102:594-607. [PMID: 37545171 DOI: 10.1002/ccd.30791] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/08/2023] [Revised: 07/05/2023] [Accepted: 07/18/2023] [Indexed: 08/08/2023]
Abstract
BACKGROUND New-generation drug-eluting stents (DES) achieved technological innovations and reported clinical advantages as compared with first-generation DES in clinical trials with 3-5 years follow-up. However, detailed clinical outcome data in very long-term follow-up is still scarce. OBJECTIVES To evaluate 10-year clinical outcomes after first- and new-generation DES implantation. METHODS In this extende follow-up study of the RESET, which is a largest randomized trial comparing everolimus-eluting stent (EES) with Sirolimus-eluting stent (SES), the study population consisted of 2892 patients from 84 centers. The primary efficacy and safety endpoints were target lesion revascularization (TLR) and a composite of death or myocardial infarction (MI), respectively. Complete 10-year follow-up was achieved in 87.9% of patients. RESULTS Cumulative 10-year incidences of TLR and non-TLR were not significantly different between EES and SES (13.9% vs. 15.7%, Log-rank p = 0.20, and 33.4% vs. 31.3%, Log-rank p = 0.30). The cumulative 10-year incidence of death/MI was also not significantly different between the groups (32.5% vs. 34.4%, Log-rank p = 0.18). Cumulative 10-year incidence of definite stent thrombosis was numerically lower in EES than in SES (1.0% vs. 1.7%, Log-rank p = 0.16). The lower risk of EES relative to SES was significant for a composite endpoint of target lesion failure (TLF: 19.6% vs. 24.9%, Log-rank p = 0.001) and target vessel failure (TVF: 26.7% vs. 31.4%, Log-rank p = 0.006). CONCLUSION During 10-year of follow-up, the risks for primary efficacy and safety endpoints were not significantly different between new-generation EES and first-generation SES, although EES compared with SES was associated with a lower risk for composite endpoints such as TLF and TVF.
Collapse
Affiliation(s)
- Hiroki Shiomi
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Ken Kozuma
- Division of Cardiology, Teikyo University Hospital, Tokyo, Japan
| | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
| | - Kazushige Kadota
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Yoshihiro Morino
- Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan
| | | | - Mitsuru Abe
- National Hospital Organization Kyoto Medical Center, Division of Cardiology, Kyoto, Japan
| | - Satoru Suwa
- Division of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
| | - Yoshiaki Ito
- Division of Cardiology, Saiseikai Yokohama-city Eastern Hospital, Yokohama, Japan
| | | | - Kazuoki Dai
- Division of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan
| | - Koichi Nakao
- Saiseikai Kumamoto Hospital Cardiovascular Center, Division of Cardiology, Kumamoto, Japan
| | | | - Ryoji Taniguchi
- Hyogo Prefectural Amagasaki General Medical Center, Division of Cardiology, Amagasaki, Japan
| | | | | | - Tomohiro Yamasaki
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Atsunori Okamura
- Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan
| | - Yoshihisa Nakagawa
- Department of Cardiology, Shiga University of Medical Science Hospital, Otsu, Japan
| | - Kenji Ando
- Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
| | | | - Kazuya Kawai
- Division of Cardiology, Chikamori Hospital, Kochi, Japan
| | - Kiyoshi Hibi
- Yokohama City University Medical Center, Division of Cardiology, Yokohama, Japan
| | - Takeshi Kimura
- Division of Cardiology, Hirakata Kohsai Hospital, Osaka, Japan
| |
Collapse
|
|
9
|
Natsuaki M, Watanabe H, Morimoto T, Kozuma K, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Hanaoka KI, Tanabe K, Morino Y, Ishikawa T, Katoh H, Nishikawa H, Tamura T, Ono K, Yamamoto K, Ishihara T, Abe M, Taniguchi R, Ikari Y, Okada K, Kimura T. Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial. EUROINTERVENTION 2023; 19:e402-e413. [PMID: 37395475 PMCID: PMC10397680 DOI: 10.4244/eij-d-23-00076] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/29/2023] [Accepted: 05/30/2023] [Indexed: 07/04/2023]
Abstract
BACKGROUND There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years. AIMS We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. METHODS The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES. RESULTS From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. CONCLUSIONS The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.
Collapse
Affiliation(s)
| | | | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
| | - Ken Kozuma
- Department of Cardiology, Teikyo University Hospital, Tokyo, Japan
| | - Kazushige Kadota
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
| | | | - Yoshihisa Nakagawa
- Department of Cardiology, Shiga University of Medical Science Hospital, Otsu, Japan
| | - Takashi Akasaka
- Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan
| | | | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Yoshihiro Morino
- Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan
| | - Tetsuya Ishikawa
- Division of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan
| | - Harumi Katoh
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
| | | | | | - Koh Ono
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Ko Yamamoto
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | | | - Mitsuru Abe
- Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
| | - Ryoji Taniguchi
- Division of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan
| | - Yuji Ikari
- Division of Cardiology, Tokai University Hospital, Isehara, Japan
| | - Kozo Okada
- Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
| | - Takeshi Kimura
- Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan
| |
Collapse
|
|
10
|
Xu K, Jiang Y, Yang W, Zhang W, Wang D, Zhao Y, Zheng S, Hao Z, Shen L, Jiang L, Qiu X, Escaned J, Tu S, Shen L, He B. Post-procedural and long-term functional outcomes of jailed side branches in stented coronary bifurcation lesions assessed with side branch Murray law-based quantitative flow ratio. Front Cardiovasc Med 2023; 10:1217069. [PMID: 37600052 PMCID: PMC10435891 DOI: 10.3389/fcvm.2023.1217069] [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: 05/04/2023] [Accepted: 07/19/2023] [Indexed: 08/22/2023] Open
Abstract
Introduction In coronary bifurcation lesions treated with percutaneous coronary intervention (PCI) using a 1-stent strategy, the occurrence of side branch (SB) compromise may lead to long-term myocardial ischemia in the SB territory. Murray law-based quantitative flow ratio (μQFR) is a novel angiography-based approach estimating fractional flow reserve from a single angiographic view, and thus is more feasible to assess SB compromise in routine practice. However, its association with long-term SB coronary blood flow remains unknown. Methods A total of 146 patients with 313 non-left main bifurcation lesions receiving 1-stent strategy with drug-eluting stents was included in this retrospective study. These lesions had post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 in SBs, and documented angiographic images of index procedure and 6- to 24-month angiographic follow-up. Post-procedural SB μQFR was calculated. Long-term SB coronary blood flow was quantified with the TIMI grading system using angiograms acquired at angiographic follow-up. Results At follow-up, 8 (2.6%), 16 (5.1%), 61 (19.5%), and 228 (72.8%) SBs had a TIMI flow grade of 0, 1, 2, and 3, respectively. The incidences of long-term SB TIMI flow grade ≤1 and ≤2 both tended to decrease across the tertiles of post-procedural SB μQFR. The receiver operating characteristic curve analyses indicated the post-procedural SB μQFR ≤0.77 was the optimal cut-off value to identify long-term SB TIMI flow grade ≤1 (specificity, 37.50%; sensitivity, 87.20%; area under the curve, 0.6673; P = 0.0064), and it was independently associated with 2.57-fold increased risk (adjusted OR, 2.57; 95% CI, 1.02-7.25; P = 0.045) in long-term SB TIMI flow grade ≤1 after adjustment. Discussion Post-procedural SB μQFR was independently associated with increased risk in impaired SB TIMI flow at long-term follow-up. Further investigations should focus on whether PCI optimization based on μQFR may contribute to improve SB flow in the long term.
Collapse
Affiliation(s)
- Ke Xu
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Yue Jiang
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Wentao Yang
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Weifeng Zhang
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Dong Wang
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Yu Zhao
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Shunwen Zheng
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Ziyong Hao
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Lan Shen
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Lisheng Jiang
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Xingbiao Qiu
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Javier Escaned
- Department of Cardiology, Hospital Clínico San Carlos IDISSC, Universidad Complutense de Madrid, Madrid, Spain
| | - Shengxian Tu
- Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China
| | - Linghong Shen
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Ben He
- Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| |
Collapse
|
|
11
|
Polavarapu RS, Pamidimukkala V, Polavarapu A, Siripuram Y, Ravella KC, Rachaputi MBR, Polavarapu N, Pulivarthi KC, Byrapaneni S, Gangasani S, Noronha M, Chinta SR. Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents. Indian Heart J 2023; 75:279-284. [PMID: 36972762 PMCID: PMC10421990 DOI: 10.1016/j.ihj.2023.03.006] [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: 10/21/2022] [Revised: 03/13/2023] [Accepted: 03/24/2023] [Indexed: 03/29/2023] Open
Abstract
OBJECTIVES To assess the long-term (3 years) safety and efficacy of Tetrilimus everolimus-eluting stent (EES) and subgroup analysis of outcomes of ultra-long (44/48 mm) Tetrilimus EES implantation in patients with long coronary lesions. MATERIAL AND METHODS In this observational, single-centre, single-arm, investigator-initiated registry, 558 patients who underwent implantation of Tetrilimus EES for the treatment of coronary artery disease were retrospectively included. The primary endpoint was occurrence of any major adverse cardiac event (MACE) at 12 months follow-up (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and we hereby report 3 years follow-up data. Stent thrombosis was assessed as a safety endpoint. A subgroup analysis of patients with long coronary lesions is also reported. RESULTS A total of 558 patients (57.0 ± 10.2 years) received 766 Tetrilimus EES (1.3 ± 0.5 stents/patient) to treat 695 coronary lesions. In subgroup analysis of 143 patients implanted with ultra-long EES, 155 lesions were intervened successfully with only one Tetrilimus EES (44/48 mm) implanted per lesion. At 3 years, event rates of 9.1% MACE with predominance of MI (4.4%), followed by 2.9% TLR and 1.7% cardiac death, and only 1.0% stent thrombosis were reported in overall population, while in a subgroup of patients implanted with ultra-long EES, 10.4% MACE and 1.5% stent thrombosis were reported. CONCLUSIONS Three years clinical outcomes showed favourable long-term safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice, including a subgroup of patients with long coronary lesions, with acceptable primary and safety endpoints.
Collapse
Affiliation(s)
| | - Vijaya Pamidimukkala
- Department of Neurosciences, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| | - Anurag Polavarapu
- Department of Cardiology, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| | - Yudhistar Siripuram
- Department of Cardiology, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| | | | | | - Naren Polavarapu
- Department of General Medicine, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| | | | - Sravanthi Byrapaneni
- Department of Oncology, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| | - Sirichandana Gangasani
- Department of General Medicine, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| | - Michael Noronha
- Department of Cardiology, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| | - Srinivasa Rao Chinta
- Department of Cardiology, Lalitha Super Specialities Hospital, Guntur, Andhra Pradesh, India.
| |
Collapse
|
|
12
|
Protty MB, Dissanayake T, Jeffery D, Hailan A, Choudhury A. Stent failure: the diagnosis and management of intracoronary stent restenosis. Expert Rev Cardiovasc Ther 2023. [PMID: 37269322 DOI: 10.1080/14779072.2023.2221852] [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: 02/06/2023] [Accepted: 06/01/2023] [Indexed: 06/05/2023]
Abstract
INTRODUCTION Despite advances in stent technology for percutaneous coronary intervention (PCI) in the treatment of coronary disease, these procedures can be complicated by stent failure manifesting as intracoronary stent restenosis (ISR). Even with advances of stent technology and medical therapy this complication is reported to affect around 10% of all percutaneous coronary intervention (PCI) procedures. Depending on stent type (drug-eluting versus bare metal), ISR have subtle differences in mechanism and timing and offer different challenges in diagnosing the etiology and subsequent treatment options. AREAS COVERED This review will be visiting the definition, pathophysiology and risk factors of ISR. EXPERT OPINION The evidence behind management options has been illustrated with the aid of real life clinical cases and summarized in a proposed management algorithm.
Collapse
Affiliation(s)
- Majd B Protty
- Morriston Cardiac Centre, Swansea Bay University Local Health Board, Swansea, UK
| | | | - Daniel Jeffery
- Morriston Cardiac Centre, Swansea Bay University Local Health Board, Swansea, UK
| | - Ahmed Hailan
- Morriston Cardiac Centre, Swansea Bay University Local Health Board, Swansea, UK
| | - Anirban Choudhury
- Morriston Cardiac Centre, Swansea Bay University Local Health Board, Swansea, UK
- Systems Immunity Research Institute, Cardiff University, Cardiff, UK
| |
Collapse
|
|
13
|
Ukaji T, Ishikawa T, Nakamura H, Mizutani Y, Yamada K, Shimura M, Kondo Y, Tamura Y, Koshikawa Y, Hisauchi I, Nakahara S, Itabashi Y, Kobayashi S, Taguchi I. Prognostic Impacts of CHADS 2, CHA 2DS 2-VASc, and CHA 2DS 2-VASc-HS Scores on Clinical Outcomes After Elective Drug-Eluting Stent Placement for De Novo Coronary Stenosis. Circ Rep 2023; 5:123-132. [PMID: 37025938 PMCID: PMC10072895 DOI: 10.1253/circrep.cr-22-0120] [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: 11/22/2022] [Revised: 01/23/2023] [Accepted: 02/07/2023] [Indexed: 03/17/2023] Open
Abstract
Background: The prognostic impact of CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-HS scores on clinical outcomes after drug-eluting stent (DES) placement has not been fully elucidated. Methods and Results: The present study was a retrospective, non-randomized, single-center, and lesion-based study. Target lesion failure (TLF), comprising cardiac death, non-fatal myocardial infarction, and target vessel revascularization, occurred in 7.1% of 872 consecutive de novo coronary lesions in 586 patients. These patients were electively and exclusively treated by DESs from January 2016 to January 2022 until July 2022 with a mean (±SD) observational interval of 411±438 days. Multivariate Cox proportional hazard analysis revealed that CHA2DS2-VASc-HS scores ≥7 (hazard ratio [HR] 1.800; 95% CI 1.06-3.05; P=0.029) was a significant predictor of cumulative TLF among 24 variables evaluated. CHADS2 scores ≥2 (HR 3.213; 95% CI 1.32-7.80; P=0.010) and CHA2DS2-VASc scores ≥5 (HR 1.980; 95% CI 1.10-3.55; P=0.022) were also significant in the multivariate analysis. Pairwise comparisons of receiver operating characteristic curves for CHADS2 score ≥2, CHA2DS2-VASc score ≥5, and CHA2DS2-VASc-HS score ≥7 showed they were equivalent in terms of predicting the incidence of TLF, with areas under the curve of 0.568, 0.575, and 0.573, respectively. Conclusions: All 3 cardiocerebrovascular thromboembolism risk scores were strong predictors of the incidence of cumulative mid-term TLF after elective DES placement, with cut-off values of 2, 5, and 7, respectively, and equivalent prognostic impacts.
Collapse
Affiliation(s)
- Tomoaki Ukaji
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Tetsuya Ishikawa
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Hidehiko Nakamura
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Yukiko Mizutani
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Kouta Yamada
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Masatoshi Shimura
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Yuki Kondo
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Yohei Tamura
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Yuri Koshikawa
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Itaru Hisauchi
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Shiro Nakahara
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Yuji Itabashi
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Sayuki Kobayashi
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| | - Isao Taguchi
- Department of Cardiology, Dokkyo Medical University, Saitama Medical Center Koshigaya Japan
| |
Collapse
|
|
14
|
Nakamaru R, Shiraishi Y, Niimi N, Ueda I, Ikemura N, Suzuki M, Noma S, Inohara T, Numasawa Y, Fukuda K, Kohsaka S. Time Trend in Incidence of Sudden Cardiac Death After Percutaneous Coronary Intervention from 2009 to 2017 (from the Japanese Multicenter Registry). Am J Cardiol 2023; 188:44-51. [PMID: 36470011 DOI: 10.1016/j.amjcard.2022.11.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/07/2022] [Revised: 10/14/2022] [Accepted: 11/10/2022] [Indexed: 12/12/2022]
Abstract
The advances in the integrated management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) have reduced subsequent cardiovascular events. Nonetheless, sudden cardiac death (SCD) remains a major concern. Therefore, we aimed to investigate the time trend in SCD incidence after PCI and to identify the clinical factors contributing to SCD. From a prospective, multicenter cohort registry in Japan, 8,723 consecutive patients with coronary artery disease undergoing PCI between 2009 and 2017 were included. We evaluated the SCD incidence 2 years after PCI; all death events were adjudicated, and SCD was defined as unexpected death without a noncardiovascular cause in a previously stable patient within 24 hours from the onset. The Fine and Gray method was used to identify the factors associated with SCD. Overall, the mean age of the patients was 68.3 ± 11.3 years, and 1,173 patients (13.4%) had heart failure (HF). During the study period, the use of second-generation drug-eluting stents increased. The 2-year cumulative incidence of all-cause mortality and SCD was 4.29% and 0.45%, respectively. All-cause mortality remained stable during the study period (p for trend = 0.98), whereas the crude incidence of SCD tended to decrease over the study period (p for trend = 0.052). HF was the strongest predictor associated with the risk of SCD (crude incidence [vs non-HF] 2.13% vs 0.19%; p <0.001). In conclusion, the incidence of SCD after PCI decreased over the last decade, albeit the high incidence of SCD among patients with HF remains concerning.
Collapse
Affiliation(s)
- Ryo Nakamaru
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan; Healthcare Quality Assessment, the University of Tokyo, Tokyo, Japan
| | - Yasuyuki Shiraishi
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Nozomi Niimi
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Ikuko Ueda
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Nobuhiro Ikemura
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Masahiro Suzuki
- Department of Cardiology National Hospital Organization Saitama Hospital, Saitama, Japan
| | - Shigetaka Noma
- Department of Cardiology Saiseikai Utsunomiya Hospital, Tochigi, Japan
| | - Taku Inohara
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Yohei Numasawa
- Department of Cardiology Japanese Red Cross Ashikaga Hospital, Tochigi, Japan
| | - Keiichi Fukuda
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Shun Kohsaka
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
| |
Collapse
|
|
15
|
National survey on the secondary preventive measures for coronary artery disease among interventional cardiologists: a report from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther 2023; 38:49-54. [PMID: 35834169 DOI: 10.1007/s12928-022-00874-y] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2022] [Accepted: 06/18/2022] [Indexed: 01/06/2023]
Abstract
Insights from recent clinical trial testing revascularization strategies have interested interventional cardiologists in optimal medical therapy and secondary prevention modalities. As no large-scale survey has been recently conducted, this report presents the results of a nationwide survey on interventionists' concerns regarding secondary prevention after percutaneous coronary intervention (PCI) and discusses medical support system needs in Japan. A questionnaire to assess the status and challenges of secondary prevention interventions by interventional cardiologists during outpatient visits was supplied to Cardiovascular Interventional Technology (CVIT)-certificated hospitals. This was answered by representative cardiologists of each hospital and comprised three queries: (1) the necessity of outpatient cardiac rehabilitation to promote post-PCI lifestyle guidance; (2) the feasibility of providing lifestyle guidance; and (3) the barriers to lifestyle guidance, during outpatient visits. Questions 1 and 2 were answered using a 5-point Likert scale. Survey responses were received from 391 hospitals (54.9% of 712 CVIT-certificated facilities). For Question 1, 327 hospitals (84.1%) answered "agree", and 386 hospitals (98.7%) answered "agree" or "somewhat agree". For Question 2, 10% of hospitals answered "agree", and "agree" and "somewhat agree" amounted to less than 50%. For Question 3, 83.5% of the facilities answered lack of time as the major reason). The next reasons included an early reverse referral to family doctors after PCI, and a lack of managerial advantage (60% and 40% of the hospitals, respectively). In conclusion, interventionists are concerned about secondary prevention for their patients. The issues clarified in the survey will be important for developing next-generation secondary prevention systems.
Collapse
|
|
16
|
Gao MJ, Cui NH, Liu X, Wang XB. Inhibition of mitochondrial complex I leading to NAD +/NADH imbalance in type 2 diabetic patients who developed late stent thrombosis: Evidence from an integrative analysis of platelet bioenergetics and metabolomics. Redox Biol 2022; 57:102507. [PMID: 36244294 PMCID: PMC9579714 DOI: 10.1016/j.redox.2022.102507] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/15/2022] [Revised: 10/05/2022] [Accepted: 10/09/2022] [Indexed: 11/22/2022] Open
Abstract
Type 2 diabetes mellitus (T2DM) is a strong indicator of late stent thrombosis (LST). Platelet bioenergetic dysfunction, although critical to the pathogenesis of diabetic macrovascular complications, remains uncharacterized in T2DM patients who developed LST. Here, we explored the mechanistic link between the alterations in platelet bioenergetics and LST in the setting of T2DM. Platelet bioenergetics, metabolomics, and their interactomes were analyzed in a nested case-control study including 15 T2DM patients who developed LST and 15 matched T2DM patients who did not develop LST (non-LST). Overall, we identified a bioenergetic alteration in T2DM patients with LST characterized by an imbalanced NAD+/NADH redox state resulting from deficient mitochondrial complex I (NADH: ubiquinone oxidoreductase) activity, which led to reduced ATP-linked and maximal mitochondrial respiration, increased glycolytic flux, and platelet hyperactivation compared with non-LST patients. Congruently, platelets from LST patients exhibited downregulation of tricarboxylic acid cycle and NAD+ biosynthetic pathways as well as upregulation of the proximal glycolytic pathway, a metabolomic change that was primarily attributed to compromised mitochondrial respiration rather than increased glycolytic flux as evidenced by the integrative analysis of bioenergetics and metabolomics. Importantly, both bioenergetic and metabolomic aberrancies in LST platelets could be recapitulated ex vivo by exposing the non-LST platelets to a low dose of rotenone, a complex I inhibitor. In contrast, normalization of the NAD+/NADH redox state, either by increasing NAD+ biosynthesis or by inhibiting NAD+ consumption, was able to improve mitochondrial respiration, inhibit mitochondrial oxidant generation, and consequently attenuate platelet aggregation in both LST platelets and non-LST platelets pretreated with low-dose rotenone. These data, for the first time, delineate the specific patterns of bioenergetic and metabolomic alterations for T2DM patients who suffer from LST, and establish the deficiency of complex I-derived NAD+ as a potential pathogenic mechanism in platelet abnormalities.
Collapse
Affiliation(s)
- Mi-Jie Gao
- Department of Clinical Laboratory, Key Clinical Laboratory of Henan Province, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, Henan, China
| | - Ning-Hua Cui
- Zhengzhou Key Laboratory of Children's Infection and Immunity, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, 450000, Henan, China
| | - Xia'nan Liu
- Department of Clinical Laboratory, Key Clinical Laboratory of Henan Province, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, Henan, China
| | - Xue-Bin Wang
- Department of Clinical Laboratory, Key Clinical Laboratory of Henan Province, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, Henan, China.
| |
Collapse
|
|
17
|
Wang X, Zhang M, Cheng J, Zhou H. Association of serum apoA-I with in-stent restenosis in coronary heart disease. BMC Cardiovasc Disord 2022; 22:355. [PMID: 35927634 PMCID: PMC9354313 DOI: 10.1186/s12872-022-02762-y] [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: 07/16/2021] [Accepted: 07/11/2022] [Indexed: 11/10/2022] Open
Abstract
Background Despite use of drug-eluting stents (DES), in-stent restenosis (ISR) continues adversely affecting clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Apolipoprotein A-I (apoA-I) has athero-protective effects. However, there is a paucity of clinical data regarding the association between apoA-I and ISR. We sought to investigate whether serum apoA-I is related to ISR after DES-based PCI. Methods In this retrospective case control study, 604 consecutive patients who underwent DES implantation before were enrolled. Patients who underwent repeat angiography within 12 months were included in the early ISR study (n = 205), while those beyond 12 months were included in the late ISR study (n = 399). ISR was defined as the presence of > 50% diameter stenosis at the stent site or at its edges. Clinical characteristics were compared between ISR and non-ISR patients in the early and late ISR study, respectively, after adjusting for confounding factors by multivariate logistic regression, stratified analysis, and propensity score matching. The predictive value was assessed by univariate and multivariate logistic regression analysis, receiver operating characteristic (ROC) curve analysis, and quartile analysis. Results In the early ISR study, 8.8% (18 of 205) patients developed ISR. Serum apoA-I in the ISR group was lower than that in the non-ISR group (1.1 ± 0.26 vs. 1.24 ± 0.23, P < 0.05). On multivariate logistic regression analysis, apoA-I was an independent risk factor for early ISR. Incidence of early ISR showed negative correlation with apoA-I and could be predicted by the combined use of apoA-I and glycosylated hemoglobin (HbA1c) level. In the late ISR study, 21.8% (87 of 399) patients developed ISR. On subgroup analysis, late ISR showed negative correlation with apoA-I irrespective of intensive lipid lowering; on multivariate logistic regression analysis, apoA-I was also an independent risk factor for late ISR. In patients with intensive lipid lowering, combined use of apoA-I, stenting time, and diabetes predicted the incidence of late ISR. Conclusions ApoA-I was an independent risk factor for ISR, and showed a negative correlation with ISR after DES-based PCI. Combined use of apoA-I and clinical indicators may better predict the incidence of ISR under certain circumstances.
Collapse
Affiliation(s)
- Xin Wang
- Department of Cardiology, School of Medicine, East Hospital, Tongji University, Shanghai, China
| | - Min Zhang
- Department of Cardiology, School of Medicine, Ren Ji Hospital, Shanghai Jiao Tong University, Shanghai, China
| | - Jie Cheng
- Center for Reproductive Medicine, School of Medicine, Ren Ji Hospital, Shanghai Jiao Tong University, Shanghai, China
| | - Hua Zhou
- Department of Cardiology, School of Medicine, East Hospital, Tongji University, Shanghai, China.
| |
Collapse
|
|
18
|
Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions. JACC: ASIA 2022; 2:446-456. [PMID: 36339368 PMCID: PMC9627890 DOI: 10.1016/j.jacasi.2022.02.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/02/2021] [Revised: 02/22/2022] [Accepted: 02/23/2022] [Indexed: 11/23/2022]
Abstract
Background Outcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions. Objectives This study sought to compare the relative performance of different types of DES for de novo long (≥25 mm) coronary artery lesions. Methods Using a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9 months. Results The primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41 mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12 months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES. Conclusions In this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120)
Collapse
|
|
19
|
Hussain KM, Jain A, Rane RP, Sweedan YG, Shahab A, Alam MDU, Hussain KMA. A Rare Case of Coronary Stent Thrombosis in the Modern Era. Cureus 2022; 14:e25207. [PMID: 35747031 PMCID: PMC9211379 DOI: 10.7759/cureus.25207] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/21/2022] [Indexed: 11/22/2022] Open
Abstract
In patients with acute coronary syndrome or obstructive coronary artery disease, stents, especially drug-eluting stents (DESs), are used for percutaneous coronary interventions (PCI). DES prevents abrupt closure of the stented artery. Stent thrombosis is an uncommon but serious complication of PCI, especially with the recent advancement of stent technology. We present a case of a 75-year-old male who initially suffered a non-ST segment elevation myocardial infarction (NSTEMI) treated appropriately with PCI and subsequently developed stent thrombosis after 10 days of initial stent placement. He then underwent emergent repeat PCI with successful replacement of stents overlapping previous stents. The patient did well following the procedure. His clopidogrel was changed to a more potent antiplatelet ticagrelor. He remained stable throughout the hospital stay and was discharged home without any further complications following the next 90 days.
Collapse
|
|
20
|
Riku S, Suzuki S, Yokoi T, Sakaguchi T, Yamamoto T, Jinno Y, Tanaka A, Ishii H, Inden Y, Murohara T. ＜Editors' Choice＞ Very long-term clinical outcomes after percutaneous coronary intervention for complex vs non-complex lesions: 10-year outcomes following sirolimus-eluting stent implantation. NAGOYA JOURNAL OF MEDICAL SCIENCE 2022; 84:352-365. [PMID: 35967938 PMCID: PMC9350579 DOI: 10.18999/nagjms.84.2.352] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/16/2021] [Accepted: 08/18/2021] [Indexed: 11/23/2022]
Abstract
Few studies have reported the long-term outcomes (>10 years) following first-generation drug-eluting stent implantation. In this single-center retrospective study, we investigated the very long-term clinical outcomes after first-generation sirolimus-eluting stent (SES) implantation in patients with complex lesions. The study included 383 consecutive patients who underwent initial SES implantation between July 2004 and January 2006; 84 and 299 of these patients reported a history of percutaneous coronary intervention (PCI) for complex and noncomplex lesions, respectively. Complex PCI was defined as having at least one of the following features: left main trunk PCI, implantation of ≥3 stents, bifurcation lesions with implantation of 2 stents, total stent length >60 mm, or chronic total occlusion. The target lesion revascularization (TLR) rate was significantly higher in the complex PCI than in the noncomplex PCI group (29.4% vs 13.0%, P=0.001), and we observed a significant intergroup difference in the late TLR (>1 year) rates (21.6% vs 9.5%, P=0.008). Late TLR continued over 10 years at a rate of 2.4%/year in the complex PCI and 1.1%/year in the noncomplex PCI group. Cox regression analysis revealed that complex PCI was related to TLR both over 10 years (hazard ratio 2.29, P=0.003) and beyond 1 year (hazard ratio 2.32, P=0.01). Cardiac death was more common in the complex PCI than in the noncomplex PCI group, particularly 4 years after PCI (15.8% vs 7.5%, P=0.031). Sudden death was the major cause of cardiac death beyond 4 years in the complex PCI group. These data indicate that long-term careful follow-up is essential for patients implanted with SES, especially those treated for complex lesions.
Collapse
Affiliation(s)
- Shuro Riku
- Department of Cardiology, Handa City Hospital, Handa, Japan
,Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Susumu Suzuki
- Department of Cardiology, Handa City Hospital, Handa, Japan
,Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Tsuyoshi Yokoi
- Department of Cardiology, Handa City Hospital, Handa, Japan
| | | | | | - Yasushi Jinno
- Department of Cardiology, Handa City Hospital, Handa, Japan
| | - Akihito Tanaka
- Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Hideki Ishii
- Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan
,Department of Cardiology, Fujita Health University Bantane Hospital, Nagoya, Japan
| | - Yasuya Inden
- Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Toyoaki Murohara
- Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| |
Collapse
|
|
21
|
Incidence and prognostic impact of the calcified nodule in coronary artery disease patients with end-stage renal disease on dialysis. Heart Vessels 2022; 37:1662-1668. [PMID: 35499643 DOI: 10.1007/s00380-022-02076-1] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2021] [Accepted: 04/08/2022] [Indexed: 01/15/2023]
Abstract
Coronary artery calcification is frequently observed in coronary artery disease (CAD) patients with end-stage renal disease (ESRD). Calcified nodule (CN) is recognized as one of the vulnerable plaque characteristics responsible for acute coronary syndrome (ACS). Although CN is a cause of ACS in only 10%, its prevalence may be higher in elderly patients and/or ESRD. The aim of this study is to investigate incidence, clinical characteristics, and prognostic impact of CN in CAD patients with ESRD on dialysis. A total of 51 vessels from 49 CAD patients with ESRD on dialysis were enrolled in this study. CN was defined as a high-backscattering mass protruding into the lumen with a strong signal attenuation and an irregular surface by optical coherence tomography. Incidence, clinical characteristics and prognosis of patients with CN were studied. Major adverse cardiac events (MACE) were defined as a composite of all-cause death, non-fatal myocardial infarction, target vessel revascularization (TVR) and stroke. CNs were observed in 30 vessels from 29 patients (59.2%). Duration of dialysis was significantly longer in CN group than in non-CN group (P = 0.03). Overall, all-cause death, cardiac death, TVR and MACE occurred in 7 (14.3%), 3 (6.1%), 11 (22.4%) and 16 (32.7%) patients during follow-up (median 826 days), respectively. Kaplan-Meier survival analysis revealed that MACE-free survival was significantly lower in patients with CN compared with those without CN (Log-rank, P = 0.036).In conclusion, CN was observed in about 60% of the CAD patients with ESRD and was associated with duration of dialysis and worse prognosis.
Collapse
|
|
22
|
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.
Collapse
|
|
23
|
Sirolimus Release from Biodegradable Polymers for Coronary Stent Application: A Review. Pharmaceutics 2022; 14:pharmaceutics14030492. [PMID: 35335869 PMCID: PMC8949664 DOI: 10.3390/pharmaceutics14030492] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2022] [Revised: 02/21/2022] [Accepted: 02/23/2022] [Indexed: 02/02/2023] Open
Abstract
Drug-eluting stents (DESs) are commonly used for the treatment of coronary artery disease. The evolution of the drug-eluting layer on the surface of the metal stent plays an important role in DES functionality. Here, the use of biodegradable polymers has emerged as an attractive strategy because it minimizes the occurrence of late thrombosis after stent implantation. Furthermore, understanding the drug-release behavior of DESs is also important for improving the safety and efficacy of stent treatments. Drug release from biodegradable polymers has attracted extensive research attention because biodegradable polymers with different properties show different drug-release behaviors. Molecular weight, composition, glass transition temperature, crystallinity, and the degradation rate are important properties affecting the behavior of polymers. Sirolimus is a conventional anti-proliferation drug and is the most widely used drug in DESs. Sirolimus-release behavior affects endothelialization and thrombosis formation after DES implantation. In this review, we focus on sirolimus release from biodegradable polymers, including synthetic and natural polymers widely used in the medical field. We hope this review will provide valuable up-to-date information on this subject and contribute to the further development of safe and efficient DESs.
Collapse
|
|
24
|
Li Y, Li J, Qiu M, Ma S, Na K, Li X, Qi Z, Chen S, Li Y, Han Y. Ticagrelor versus clopidogrel in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention. Catheter Cardiovasc Interv 2022; 99 Suppl 1:1395-1402. [PMID: 35032148 DOI: 10.1002/ccd.30077] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/26/2021] [Accepted: 01/02/2022] [Indexed: 12/29/2022]
Abstract
OBJECTIVES To evaluate the effectiveness and safety of ticagrelor versus clopidogrel in patients with acute coronary syndromes (ACS) undergoing complex percutaneous coronary intervention (PCI). BACKGROUND It remains inconclusive whether ticagrelor is superior to clopidogrel in ACS patients undergoing complex PCI in real-world practice. METHODS Based on an all-comers PCI registry, we compared the long-term effectiveness and safety between ticagrelor and clopidogrel in ACS patients undergoing complex PCI, defined as PCI procedures for complex lesions including bifurcation, chronic total occlusion, ostial, tortuous, calcific, diffused, thrombus-containing, and restenotic lesions. The primary ischemic outcome was a composite of cardiac death, myocardial infarction, or stroke. The safety outcome comprised Bleeding Academic Research Consortium (BARC) types 2, 3, and 5 bleeding. Propensity score matching (PSM) was performed to reduce bias. RESULTS Among ACS patients who underwent complex PCI, 4373 (35.2%) and 8065 (64.8%) received dual antiplatelet therapy based on ticagrelor and clopidogrel, respectively. The incidences of composite ischemic events (before PSM: 1.74% vs. 2.84%; after PSM: 1.50% vs. 2.65%; p < 0.01 for both) and all-cause death (before PSM: 1.23% vs. 2.12%, p < 0.01; after PSM: 1.09% vs. 1.81%, p = 0.02) were significantly lower in the ticagrelor-treated than in the clopidogrel-treated group. There was no significant difference in BARC types 2, 3, and 5 bleeding between groups. CONCLUSIONS Whilst the risk of major bleeding was comparable between the two drugs, ticagrelor was associated with a significantly lower risk of ischemic events than clopidogrel in ACS patients undergoing complex PCI.
Collapse
Affiliation(s)
- Yuzhuo Li
- Postgraduate Training Base of The General Hospital of Northern Theater Command, Jinzhou Medical University, Jinzhou, Liaoning, China.,Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Jing Li
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Miaohan Qiu
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Sicong Ma
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Kun Na
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Xiaoying Li
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Zizhao Qi
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Sanbao Chen
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Yi Li
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| | - Yaling Han
- Department of Cardiology, The General Hospital of Northern Theater Command, Shenyang, China
| |
Collapse
|
|
25
|
Kumar T, Shah M, Prajapati A, Pathak S. A case of “very” very late stent thrombosis: More than 12 years after DES. J Family Med Prim Care 2022; 11:1545-1548. [PMID: 35516662 PMCID: PMC9067209 DOI: 10.4103/jfmpc.jfmpc_1533_21] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2021] [Revised: 08/01/2021] [Accepted: 11/24/2021] [Indexed: 11/04/2022] Open
|
|
26
|
Yoshikawa Y, Shiomi H, Morimoto T, Takeji Y, Matsumura-Nakano Y, Yamamoto K, Yamamoto E, Kato ET, Watanabe H, Saito N, Domei T, Tada T, Nawada R, Onodera T, Suwa S, Tamura T, Ishii K, Ando K, Furukawa Y, Kadota K, Nakagawa Y, Kimura T. Stent-Related Adverse Events as Related to Dual Antiplatelet Therapy in First- vs Second-Generation Drug-Eluting Stents. JACC. ASIA 2021; 1:345-356. [PMID: 36341224 PMCID: PMC9627913 DOI: 10.1016/j.jacasi.2021.08.010] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/13/2021] [Revised: 08/09/2021] [Accepted: 08/19/2021] [Indexed: 12/03/2022]
Abstract
Background There are limited data on the long-term stent-related adverse events as related to the duration of dual antiplatelet therapy (DAPT) in second-generation (G2) drug-eluting stents (DES) compared with first-generation (G1) DES. Objectives This study sought to compare the long-term stent-related outcomes of G2-DES with those of G1-DES. Methods The study group consisted of 15,009 patients who underwent their first coronary revascularization with DES from the CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Grafting) Registry Cohort-2 (first-generation drug-eluting stent [G1-DES] period; n = 5,382) and Cohort-3 (second-generation drug eluting stent [G2-DES] period; n = 9,627). The primary outcome measures were definite stent thrombosis (ST) and target vessel revascularization (TVR). Results The cumulative 5-year incidences of definite ST and TVR were significantly lower in the G2-DES group than in the G1-DES group (0.7% vs 1.4%; P < 0.001; and 16.2% vs 22.1%; P < 0.001, respectively). The lower adjusted risk of G2-DES relative to G1-DES for definite ST and TVR remained significant (HR: 0.53; 95% CI: 0.37-0.76; P < 0.001; and HR: 0.74; 95% CI: 0.68-0.81; P < 0.001, respectively). In the landmark analysis that was based on the DAPT status at 1 year, the lower adjusted risk of on-DAPT status relative to off-DAPT was significant for definite ST beyond 1 year in the G1-DES stratum (HR: 0.42; 95% CI: 0.24-0.76; P = 0.004) but not in the G2-DES stratum (HR: 0.66; 95% CI: 0.26-1.68; P = 0.38) (P interaction = 0.14). Conclusions G2-DES compared with G1-DES were associated with a significantly lower risk for stent-related adverse events, including definite ST and TVR. DAPT beyond 1 year was associated with a significantly lower risk for very late ST of G1-DES but not for that of G2-DES.
Collapse
Key Words
- ACS, acute coronary syndrome
- ARC, Academic Research Consortium
- ARC-HBR, Academic Research Consortium High Bleeding Risk
- BMS, bare-metal stent
- CABG, coronary artery bypass grafting
- DAPT, dual antiplatelet therapy
- DES, drug-eluting stent(s)
- EES, everolimus-eluting stent(s)
- G1, first-generation
- G2, second-generation
- PCI, percutaneous coronary intervention
- PES, paclitaxel-eluting stent(s)
- SES, sirolimus-eluting stent(s)
- ST, stent thrombosis
- TVR, target vessel revascularization
- ZES, zotarolimus-eluting stent(s)
- drug-eluting stent
- dual antiplatelet therapy
- stent thrombosis
Collapse
Affiliation(s)
- Yusuke Yoshikawa
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Hiroki Shiomi
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Takeshi Morimoto
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
| | - Yasuaki Takeji
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Yukiko Matsumura-Nakano
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Ko Yamamoto
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Erika Yamamoto
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Eri T. Kato
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Hirotoshi Watanabe
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Naritatsu Saito
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Takenori Domei
- Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan
| | - Takeshi Tada
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
| | - Ryuzo Nawada
- Department of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan
| | - Tomoya Onodera
- Department of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan
| | - Satoru Suwa
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
| | | | - Katsuhisa Ishii
- Department of Cardiology, Kansai Electric Power Hospital, Osaka, Japan
| | - Kenji Ando
- Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan
| | - Yutaka Furukawa
- Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan
| | - Kazushige Kadota
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
| | - Yoshihisa Nakagawa
- Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital, Otsu, Japan
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - CREDO-Kyoto PCI/CABG Registry Cohort-2 and Cohort-3 Investigators
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
- Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
- Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
- Department of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan
- Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan
- Department of Cardiology, Tenri Hospital, Tenri, Japan
- Department of Cardiology, Kansai Electric Power Hospital, Osaka, Japan
- Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan
- Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital, Otsu, Japan
| |
Collapse
|
|
27
|
Matoba T, Yasuda S, Kaikita K, Akao M, Ako J, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H. Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the AFIRE Trial. JACC Cardiovasc Interv 2021; 14:2330-2340. [PMID: 34736731 DOI: 10.1016/j.jcin.2021.07.045] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/19/2021] [Revised: 07/22/2021] [Accepted: 07/27/2021] [Indexed: 10/20/2022]
Abstract
OBJECTIVES The aim of this AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial subgroup analysis was to examine rivaroxaban monotherapy benefits and their relation to the time between stenting and enrollment among patients after coronary stenting. BACKGROUND Of 2,215 patients with atrial fibrillation and stable coronary artery disease in the AFIRE trial, rivaroxaban monotherapy was noninferior to rivaroxaban plus antiplatelet therapy (combination therapy) in terms of efficacy and superior for safety endpoints. However, thrombotic risk after antiplatelet therapy cessation remained a concern among 1,444 patients who had undergone coronary stenting >1 year before enrollment. METHODS The benefits of rivaroxaban monotherapy in coronary stenting subgroups were assessed for efficacy (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death of any cause), safety (major bleeding defined according to International Society on Thrombosis and Haemostasis criteria), ischemic endpoints, net adverse clinical event, and time between stenting and enrollment. RESULTS Efficacy and safety endpoints for monotherapy were superior to combination therapy, with HRs of 0.70 for efficacy (95% CI: 0.50-0.98; P = 0.036) and 0.55 for safety (95% CI: 0.33-0.92; P = 0.019). For ischemic endpoints, the HR was 0.82 (95% CI: 0.58-1.15; P = 0.240). The HR became smaller with longer time between stenting and enrollment (efficacy, P for interaction = 0.158; safety, P = 0.097). CONCLUSIONS In patients with atrial fibrillation after coronary stenting, the benefits of rivaroxaban monotherapy for efficacy and safety endpoints were consistent with those in the whole AFIRE trial population. The benefits became apparent with longer time between stenting and enrollment. (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study [AFIRE]; UMIN000016612, NCT02642419).
Collapse
Affiliation(s)
- Tetsuya Matoba
- Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
| | - Satoshi Yasuda
- Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; National Cerebral and Cardiovascular Center, Suita, Japan
| | - Koichi Kaikita
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Kiyotake, Japan
| | - Masaharu Akao
- Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
| | - Junya Ako
- Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan
| | - Masato Nakamura
- Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan
| | - Katsumi Miyauchi
- Department of Cardiovascular Medicine Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan
| | - Nobuhisa Hagiwara
- Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan
| | - Kazuo Kimura
- Cardiovascular Center, Yokohama City University Medical Center, Yokohama, Japan
| | | | - Kunihiko Matsui
- Department of General Medicine and Primary Care, Kumamoto University Hospital, Kumamoto, Japan
| | - Hisao Ogawa
- National Cerebral and Cardiovascular Center, Suita, Japan; Kumamoto University, Kumamoto, Japan
| |
Collapse
|
|
28
|
Genetic risk model for in-stent restenosis of second-and third-generation drug-eluting stents. iScience 2021; 24:103082. [PMID: 34585120 PMCID: PMC8455661 DOI: 10.1016/j.isci.2021.103082] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2021] [Revised: 07/20/2021] [Accepted: 08/31/2021] [Indexed: 12/02/2022] Open
Abstract
The new generation, i.e., second- and third-generation, drug-eluting stents (DESs) remain a risk of in-stent restenosis (ISR). We evaluated the power of a genetic risk score (GRS) model to identify high-risk populations for new generation DES ISR. We enrolled patients with coronary artery disease (CAD) treated with new generations DESs by a single-center cohort study in Taiwan and evaluated their genetic profile. After propensity score matching, there were 343 patients and 153 patients in the derivation and validation cohorts, respectively. Five selected single-nucleotide polymorphisms (SNPs), i.e., SNPs in CAMLG, GALNT2, C11orf84, THOC5, and SAMD11, were included to calculate the GRS for new generation DES ISR. In the derivation and the validation cohorts, patients with a GRS greater than or equal to 3 had significantly higher new generation DES ISR rates. We provide biological information for interventional cardiologists prior to percutaneous coronary intervention by specific five SNP-derived GRS.
A validated GRS model identified high-risk population for new generation DES ISR This GRS includes 5 SNPs in exons: CAMLG, GALNT2, C11orf84, THOC5, and SAMD11 The patients with high GRSs (≥3) had higher rates of new generation DES ISR The GRS provides crucial information in shared decision-making process clinically
Collapse
|
|
29
|
Natsuaki M, Kimura T. Antiplatelet Therapy After Percutaneous Coronary Intervention - Past, Current and Future Perspectives. Circ J 2021; 86:741-747. [PMID: 34556592 DOI: 10.1253/circj.cj-21-0751] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
Optimal antiplatelet therapy after percutaneous coronary intervention (PCI) has been changed in parallel with the improvements of coronary stent and antiplatelet therapy. Over the past 25 years, dual antiplatelet therapy (DAPT) with aspirin plus P2Y12inhibitor has been the standard of care used after coronary stent implantation. First-generation drug-eluting stent (DES) appeared to increase the risk of late stent thrombosis, and duration of DAPT was prolonged to 12 months. DAPT duration up to 12 months was the dominant strategy after DES implantation in the subsequent >10 years, although there was no dedicated randomized controlled trial supporting this recommendation. The current recommendation of DAPT duration is getting shorter due to the development of new-generation DES, use of a P2Y12inhibitor as a monotherapy, and the increasing prevalence of high-bleeding risk patients. Furthermore, an aspirin-free strategy is now emerging as one of the novel strategies of antiplatelet therapy after PCI. This review gives an overview of the history of antiplatelet therapy and provides current and future perspectives on antiplatelet therapy after PCI.
Collapse
Affiliation(s)
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
| |
Collapse
|
|
30
|
Zeng M, Yan X, Wu W. Risk factors for revascularization and in-stent restenosis in patients with triple-vessel disease after second-generation drug-eluting stent implantation: a retrospective analysis. BMC Cardiovasc Disord 2021; 21:446. [PMID: 34535088 PMCID: PMC8447745 DOI: 10.1186/s12872-021-02259-0] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2021] [Accepted: 08/31/2021] [Indexed: 12/05/2022] Open
Abstract
Objectives Coronary artery disease (CAD) is a common cardiac disease with high morbidity and mortality, and triple-vessel disease (TVD) is a severe type of CAD. This study investigated risk factors for revascularization and in-stent restenosis (ISR) in TVD patients who underwent second-generation drug-eluting stent implantation. Methods A retrospective clinical study was conducted, and 246 triple-vessel disease (TVD) patients with 373 vessels after second-generation drug-eluting stent (DES) implantation who received follow-up coronary angiography (CAG) were consequently enrolled. According to the follow-up angiography, patients were categorized into the revascularization group and nonrevascularization group as well as the in-stent restenosis (ISR) group and non-ISR group. Univariate and multivariate logistic regression analyses were used to identify risk factors for revascularization and ISR. Receiver operating characteristic (ROC) curve with area under the curve (AUC) analysis was performed to assess the predictive power of these risk factors. Results In the median follow-up period of 28.0 (14.0, 56.0) months, 142 TVD patients (57.7%) with 168 vessels underwent revascularization, and ISR occurred in 43 TVD patients (17.5%) with 47 vessels after second-generation DES implantation. Compared to the nonrevascularization group, the revascularization group presented with an increased rate of current smoking and higher levels of TC, LDL-C, HDL-C, non-HDL-c, ApoB, neutrophils, and Hs-CRP as well as a longer follow-up of months but with a lower level of HDL-C. In addition, patients in the ISR group had an older age, longer follow-up (months) and elevated rates of current smoking and stage 4–5 chronic kidney disease (CKD4-5). In multivariate analysis, current smoking and higher non-HDL-c were independent risk factors for revascularization. In addition, older age, current smoking and CKD4-5 were considered independent risk factors for ISR. Importantly, the receiver operating characteristic curve showed that non-HDL-C and age displayed predictive power for revascularization and ISR, respectively. Conclusion Current smoking is an independent risk factor for both revascularization and in-stent restenosis. Higher non-HDL-c is independently related to revascularization; moreover, increased age and CKD4-5 are potential risk factors for ISR in TVD patients after second-generation drug-eluting stent implantation.
Collapse
Affiliation(s)
- MengYing Zeng
- Department of Cardiology, Peking Union Medical College Hospital (Dongdan Campus), Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China
| | - XiaoWei Yan
- Department of Cardiology, Peking Union Medical College Hospital (Dongdan Campus), Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
| | - Wei Wu
- Department of Cardiology, Peking Union Medical College Hospital (Dongdan Campus), Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China
| |
Collapse
|
|
31
|
Matsuda H, Suzuki Y. Long-term (beyond 5 years) clinical impact of Xience everolimus-eluting stent implantation. Health Sci Rep 2021; 4:e365. [PMID: 34522790 PMCID: PMC8425589 DOI: 10.1002/hsr2.365] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/21/2020] [Revised: 07/28/2021] [Accepted: 08/02/2021] [Indexed: 12/05/2022] Open
Abstract
OBJECTS We aim at examining the long-term clinical outcome after Xience everolimus-eluting stent (X-EES) implantation. BACKGROUND Long-term clinical outcomes beyond 5 years after X-EES implantation remain unclear. METHODS This retrospective study has collected data from 1184 consecutive patients, corresponding to 1463 lesions, who were treated with X-EES alone in the Nagoya Heart Center between January 2010 and December 2013. The primary endpoint was the 10-year cumulative incidence of target lesion failure (TLF), defined as cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Definite/probable stent thrombosis (ST) was evaluated as a secondary outcome. RESULTS At 10 years, the cumulative incidence of TLF was recorded to be 12.4%, whereas that of cardiac death, target vessel MI, and clinically indicated TLR was at 4.4%, 4.1%, and 7.8%, respectively. The cumulative rate of definite/probable ST was observed to remain low (0.3% at 30 days; 0.3% at 1 year; 0.6% at 5 years; and 1.1% at 10 years). In the multivariate analysis, the risk factors of TLF were insulin-treated diabetes (hazard ratio (HR), 1.93; 95% confidence interval (CI), 1.13-3.29; P = .02), left ventricular dysfunction (HR, 2.28; 95% CI, 1.43-3.62; P < .01), hemodialysis (HR, 2.22; 95% CI, 1.39-3.56; P < .01), prior percutaneous coronary intervention (HR, 1.68; 95% CI, 1.18-2.41; P < .01), peripheral vascular disease (HR, 1.70; 95% CI, 1.07-2.69; P < .01), severe calcification (HR, 2.08; 95% CI, 1.36-3.09; P < .01), and in-stent restenosis (HR, 2.93; 95% CI, 1.64-4.89; P < .01). CONCLUSIONS The incidence rates of the long-term adverse effects after X-EES implantation, such as late TLR and ST, were determined to be low in this study; however, they increased over time until 10 years after stent implantation.
Collapse
|
|
32
|
Tamez H, Secemsky EA, Valsdottir LR, Moussa ID, Song Y, Simonton CA, Gibson CM, Popma JJ, Yeh RW. Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries. EUROINTERVENTION 2021; 17:e380-e387. [PMID: 32863243 PMCID: PMC9724866 DOI: 10.4244/eij-d-19-01031] [Citation(s) in RCA: 36] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/24/2020] [Indexed: 11/23/2022]
Abstract
BACKGROUND In-stent restenosis (ISR) is highly prevalent and leads to repeat revascularisation. Long-term implications of ISR are poorly understood. AIMS This study aimed to evaluate the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR. METHODS National Cardiovascular Data Registry CathPCI records for individuals aged ≥65 years undergoing PCI from July 2009 to December 2014 were linked to Medicare claims. Baseline characteristics and long-term rates of death, myocardial infarction (MI), repeat revascularisation including target vessel revascularisation (TVR), and major adverse cardiovascular and cerebrovascular events (MACCE) were compared between ISR PCI versus de novo lesion PCI. RESULTS Of 653,304 individuals, 10.2% underwent ISR PCI and 89.8% underwent de novo lesion PCI. The median duration of follow-up was 825 days (quartile 1: 352 days-quartile 3: 1,379 days). The frequency of MACCE (55.6% vs 45.0%; p<0.001), all-cause mortality (27.8% vs 25.5%; p<0.001), MI (19.0% vs 12.3%; p<0.001), repeat revascularisation (31.9% vs 18.6%; p<0.001), TVR (22.4% vs 8.0%; p<0.001), and stroke (8.8% vs 8.3%; p=0.005) was higher after ISR PCI. After multivariable adjustment, ISR PCI remained associated with worse long-term outcomes than after de novo lesion PCI (hazard ratio [HR] for MACCE 1.24 [95% CI: 1.22, 1.26], mortality 1.07 [95% CI: 1.05, 1.09], MI 1.44 [95% CI: 1.40, 1.48], repeat revascularisation 1.55 [95% CI: 1.51, 1.59], and TVR 2.50 [95% CI: 2.42, 2.58]). CONCLUSIONS ISR PCI was common and was associated with a significantly higher risk of recurrent long-term major ischaemic events compared to patients undergoing de novo lesion PCI. There remains a need for new strategies to minimise ISR.
Collapse
Affiliation(s)
- Hector Tamez
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA
| | | | | | | | | | | | | | | | | |
Collapse
|
|
33
|
Shibata K, Kameshima M, Fujiyama H, Ehara M, Suzuki Y, Yamada S. Obesity May Not Be a Risk of Non-Target Lesion Revascularization in the Elderly Patients. Int Heart J 2021; 62:726-733. [PMID: 34276007 DOI: 10.1536/ihj.20-708] [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: 11/18/2022]
Abstract
Obesity is assumed to be one of the robust risk factors for coronary artery disease. However, the effects of obesity on the progression of atherosclerosis in patients in different age groups after percutaneous coronary intervention (PCI) remain unclear. This study aimed to examine the effect of obesity on prognosis in different age groups.Consecutive patients who underwent urgent or elective PCI were surveyed for this study and were then divided into the elderly group and middle-aged group with a cut-off age of 70 years. All patients underwent coronary angiography or coronary computed tomography angiography 1 year after PCI to examine the progression of atherosclerosis. The primary endpoint was revascularization for a new lesion within 2 years after PCI. In addition, the main effects and correlations between obesity and age were examined. Multivariate logistic regression analysis was conducted to identify independent predictors of non-target lesion revascularization (non-TLR).Of the 711 patients who met the criteria and were available for follow-up analysis, the incidence of non-TLR within 2 years was 97/711 (13.6%). The higher incidence of non-TLR in patients with obesity was observed only in the middle-aged group. Furthermore, in the multivariate analysis, obesity was independently associated with non-TLR only in the middle-aged group.The findings of the present study would enable us to construct the hypothesis that obesity in elderly patients may not be an independent predictor of the incidence of non-TLR, indicating that the management to prevent non-TLR may vary depending on the age of the patient.
Collapse
Affiliation(s)
- Kenichi Shibata
- Department of Cardiac Rehabilitation, Nagoya Heart Center.,Department of Integrated Health Sciences, Nagoya University Graduate School of Medicine
| | | | | | | | | | - Sumio Yamada
- Department of Integrated Health Sciences, Nagoya University Graduate School of Medicine
| |
Collapse
|
|
34
|
Drug-eluting stent thrombosis: current and future perspectives. Cardiovasc Interv Ther 2021; 36:158-168. [PMID: 33439454 DOI: 10.1007/s12928-021-00754-x] [Citation(s) in RCA: 46] [Impact Index Per Article: 11.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2020] [Accepted: 12/31/2020] [Indexed: 12/19/2022]
Abstract
Over the past 40 years, the safety and efficacy of percutaneous coronary intervention has dramatically improved by overcoming several challenges. The introduction of drug-eluting stent (DES) in particular was a major breakthrough in interventional cardiology. Compared to bare-metal stents, first-generation DES (G1-DES) has dramatically reduced the rates of in-stent restenosis and subsequent target lesion revascularization. However, major safety concerns surrounding stent thrombosis (ST) emerged with G1-DES in clinical practice as a result of the high incidences of death, myocardial infarction, and repeat revascularization associated with ST. To overcome these limitations, second-generation DES (G2-DES) has been developed with an improved stent platform with thinner strut and biocompatible durable or biodegradable polymers. Indeed, G2-DES, when compared with G1-DES, has improved clinical outcomes by reducing the risk of late thrombotic events while maintaining anti-restenotic efficacy, whereas ST still occurs, even with the use of G2-DES. This review gives an overview of pathophysiology, risk factors, and outcomes of ST after DES implantation. Additionally, we discuss the management and prevention of ST.
Collapse
|
|
35
|
Ng AKY, Ng PY, Siu CW, Jim MH. Factors associated with long-term major adverse cardiac events of coronary bioresorbable vascular scaffold. Cardiovasc Interv Ther 2021; 36:462-469. [PMID: 33387354 DOI: 10.1007/s12928-020-00723-w] [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: 06/22/2020] [Accepted: 10/14/2020] [Indexed: 11/25/2022]
Abstract
The long-term clinical outcomes after implantation of bioresorbable vascular scaffolds (BVS) in a real-world cohort were not well described. To identify factors associated with major adverse cardiovascular events (MACE) on long-term follow-up after implantation of BVS in patients undergoing elective percutaneous coronary intervention (PCI). This was an observational study based on a hospital registry of percutaneous coronary intervention. Participants were consecutive patients who underwent PCI and implanted with at least one everolimus-eluting BVS (Absorb®) in a single center between 2014 and 2017. Among the 170 cases analyzed (mean age 60.4 ± 10.7), a total of 203 Absorb BVS were implanted. MACE developed in 33 (19.4%) patients over a median follow-up period of 61 months, including 9 (5.3%) deaths, 13 (7.6%) non-fatal myocardial infarction and 19 (11.2%) ischemia driven target vessel revascularization. Definite or probable stent thrombosis developed in 4 (2.4%) patients. In crude analysis, history of smoking and initial presentation of non-ST elevation-acute coronary syndrome (NSTE-ACS) were predictors of long-term MACE. In adjusted analysis, presentation with NSTE-ACS was an independent predictor of long-term MACE [adjusted odds ratio (OR) 4.52; 95% confidence interval (95% CI) 1.50 to 13.6, P = 0.007]. Among patients receiving implantation of ABSORB BVS, presentation with NSTE-ACS was an independent predictor of MACE after a median follow-up period of 61 months. Future research is needed to confirm these findings and to determine the long-term safety of BVS in patients with NSTE-ACS.
Collapse
Affiliation(s)
- Andrew Kei-Yan Ng
- Cardiac Medical Unit, Grantham Hospital, 125 Wong Chuk Hang Road, Hong Kong Sar, China
| | - Pauline Yeung Ng
- Department of Adult Intensive Care, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong SAR, China
- Division of Respiratory and Critical Care Medicine, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China
| | - Chung-Wah Siu
- Department of Medicine, Queen Mary Hospital, The University of Hong Kong SAR, Hong Kong SAR, China
| | - Man-Hong Jim
- Cardiac Medical Unit, Grantham Hospital, 125 Wong Chuk Hang Road, Hong Kong Sar, China.
| |
Collapse
|
|
36
|
The birth, decline, and contemporary re-emergence of endovascular brachytherapy for prevention of in-stent restenosis. Brachytherapy 2020; 20:485-493. [PMID: 33132069 DOI: 10.1016/j.brachy.2020.09.012] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2020] [Revised: 09/13/2020] [Accepted: 09/18/2020] [Indexed: 01/08/2023]
Abstract
Despite the advent of drug-eluting stents and dual antiplatelet therapy in the interventional management of cardiovascular disease, restenosis rates remain high with significant sequelae. Endovascular brachytherapy-popular in the 1990s and early 2000s-has recently resurfaced as a cost-effective treatment option. In this work, we outline the history of endovascular brachytherapy starting with its earliest promise in the 1990s. We discuss the development of drug-eluting stents and dual antiplatelet strategies and their impact on the perceived benefit of endovascular brachytherapy. For the contemporary era, we propose novel roles for endovascular brachytherapy in complex coronary artery disease and in high-risk patients managed with drug-eluting stents. We discuss the impetus for reducing the requirement and duration of dual antiplatelet therapy using endovascular brachytherapy. We also review innovative opportunities for endovascular brachytherapy after bare-metal stent placement in both coronary and noncoronary territories and offer economic arguments in favor of endovascular brachytherapy. Trials of endovascular brachytherapy in these regimes are merited.
Collapse
|
|
37
|
Ishihara T, Yamaji K, Iida O, Kohsaka S, Inohara T, Shinke T, Ando H, Amano T, Sakata Y, Mano T, Ikari Y. Impact of peripheral artery disease on short-term outcomes after percutaneous coronary intervention: A report from Japanese nationwide registry. PLoS One 2020; 15:e0240095. [PMID: 33021993 PMCID: PMC7537874 DOI: 10.1371/journal.pone.0240095] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2020] [Accepted: 09/21/2020] [Indexed: 12/24/2022] Open
Abstract
Atherosclerosis is a systemic process. As the population ages, increasingly more patients who undergo coronary revascularization are complicated with peripheral artery disease (PAD). However, the large body of evidence in this area has not been limited to analysis from trial-based data from younger and relatively uncomplicated patients in Western countries. The impact of PAD on the outcomes can differ by patient characteristics, and integrated analysis of large-scale data is necessary. J-PCI is a universal (all-comer) nationwide registration system in Japan, regulated and audited by professional society that controls national board-certification system. For the present study, we extracted data of 894,014 percutaneous coronary intervention (PCI) cases performed between 2014 and 2017 (mean age 70.2 years [standard deviation 11.0]). In-hospital outcomes of PAD and Non-PAD patients were compared. PAD was defined as a previous history of stenosis of peripheral arteries or abdominal aortic aneurysm. Primary outcome was in-hospital mortality, and multivariable modeling was performed. A total of 66,891 patients (8.1%) had PAD. Crude in-hospital mortality rate was higher in this group (0.99% vs. 0.67% in Non-PAD group). PAD was associated with an increased risk of in-hospital mortality (odds ratio [OR] 1.383 [95% confidence interval 1.251-1.528]). However, the impact of PAD differed by kidney condition (OR 1.578 [1.370-1.821] for patients with chronic kidney disease [CKD] and OR 1.234 [1.076-1.416] without CKD: P for interaction 0.005), and by clinical presentation: PAD was not associated with an increased risk of in-hospital mortality in patients undergoing PCI for silent ischemia (OR 1.211 [0.8701-1.685]: P for interaction 0.002). Presence of PAD was independently associated with in-hospital mortality in patients receiving PCI. However, its impact varied substantially by the patient background or indication of the procedure.
Collapse
Affiliation(s)
| | - Kyohei Yamaji
- Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
| | - Osamu Iida
- Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan
| | - Shun Kohsaka
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Taku Inohara
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Toshiro Shinke
- Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University School of Medicine, Tokyo, Japan
| | - Hirohiko Ando
- Department of Cardiology, Aichi Medical University, Nagakute, Japan
| | - Tetsuya Amano
- Department of Cardiology, Aichi Medical University, Nagakute, Japan
| | - Yasushi Sakata
- Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan
| | - Toshiaki Mano
- Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan
| | - Yuji Ikari
- Department of Cardiology, Tokai University Hospital, Isehara, Japan
| |
Collapse
|
|
38
|
Fujii K, Otsuji S, Yamamoto W, Takiuchi S, Ishibuchi K, Tamaru H, Kakishita M, Ibuki M, Hasegawa K, Ishii R, Nakabayashi S, Higashino Y. Impact of optical coherence tomography-derived neointimal tissue morphology on development of very late in-stent restenosis. Catheter Cardiovasc Interv 2020; 96:E398-E405. [PMID: 32077557 DOI: 10.1002/ccd.28799] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/26/2019] [Revised: 01/09/2020] [Accepted: 02/10/2020] [Indexed: 11/10/2022]
Abstract
OBJECTIVES This study evaluated the progression of very late in-stent restenosis (VL-ISR) by analyzing four serial coronary angiography (CAG) images and its correlation with neointimal tissue characterization of the VL-ISR lesions on optical coherence tomography (OCT). BACKGROUND Recently, VL-ISR is occasionally observed beyond a few years after drug-eluting stents (DESs) implantation. METHODS This study analyzed 50 VL-ISR lesions after DES in which 4 serial CAGs over a period of 2 years, including at baseline procedure, 9 months after baseline procedure, 12 months before VL-ISR, and at the time of VL-ISR, were performed. Neointimal tissue characteristics by OCT were categorized as homogeneous, heterogeneous with invisible strut (Type I), heterogeneous with visible strut (Type II), speckled (Type III), or heterogeneous with sharply delineated border (Type IV). RESULTS From the development process, 23 VL-ISRs (46%) were categorized as rapid progression and 27 (54%) as gradual progression. The five categories of neointimal tissue composition significantly differed between lesions with rapid and gradual progression. Homogeneous neointima and Type IV heterogeneous neointima were observed only in lesions with gradual progression. Moreover, most Type I heterogeneous neointima was identified in lesions with gradual progression. Instead, main neointimal tissue components of lesions with rapid progression were Type II (43%) and Type III (43%) heterogeneous neointima. CONCLUSION The progression rate of in-stent atherosclerotic changes is gradual, whereas organized thrombus could be associated with an increased risk of rapid neointimal growth. The two types of stenosis progression provide a new insight into the mechanism of VL-ISR development after DES implantation.
Collapse
Affiliation(s)
- Kenichi Fujii
- Department of Medicine II, Kansai Medical University, Hirakata, Japan.,Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Satoru Otsuji
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Wataru Yamamoto
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Shin Takiuchi
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Kasumi Ishibuchi
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Hiroto Tamaru
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Mikio Kakishita
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Motoaki Ibuki
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Katsuyuki Hasegawa
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Rui Ishii
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Sho Nakabayashi
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| | - Yorihiko Higashino
- Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan
| |
Collapse
|
|
39
|
Amano H, Kubo S, Osakada K, Miura K, Ohya M, Shimada T, Murai R, Tada T, Tanaka H, Fuku Y, Goto T, Kadota K. Clinical Outcomes and Angiographic Results of Bailout Stenting for Guide Catheter-Induced Iatrogenic Coronary Artery Dissection - Impact of Stent Type. Circ J 2020; 84:1746-1753. [PMID: 32893259 DOI: 10.1253/circj.cj-20-0123] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [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 Guide catheter-induced iatrogenic coronary artery dissection is a rare but feared complication. When it occurs, bailout stenting is widely performed; however, its prognosis and the impact of stent type remains unclear. METHODS AND RESULTS The study population consisted of 77,257 consecutive patients (coronary angiography, 55,864; percutaneous coronary intervention, 21,393) between 2000 and 2015. We investigated the incidence, clinical outcomes, and angiographic results after bailout stenting and compared by stent type: bare-metal stent (BMS) and drug-eluting stent (DES). Iatrogenic coronary artery dissection occurred in 105 patients (incidence rate, 0.14%). All cases of iatrogenic coronary artery dissection that were recognized as requiring bailout procedure could be managed by stent implantation, and no patients died during bailout procedure. The 5-year cumulative incidences of cardiac death, target lesion revascularization, and major adverse cardiac events were 11.3%, 10.3%, and 21.0%, respectively. The binary restenosis rate was 10.4%, and it was not significantly different between BMS and DES implantation. In lesions with preprocedural stenosis, however, it was significantly lower in the DES group than in the BMS group. On the other hand, coronary artery dissection recurred in 8 patients, which was observed only after DES implantation. CONCLUSIONS The immediate and long-term outcomes of bailout stenting for iatrogenic coronary artery dissection were acceptable. Although DES may be favorable for stenotic lesions, coronary artery dissection can recur after DES implantation.
Collapse
Affiliation(s)
- Hidewo Amano
- Department of Cardiology, Kurashiki Central Hospital
| | - Shunsuke Kubo
- Department of Cardiology, Kurashiki Central Hospital
| | - Kohei Osakada
- Department of Cardiology, Kurashiki Central Hospital
| | - Katsuya Miura
- Department of Cardiology, Kurashiki Central Hospital
| | - Masanobu Ohya
- Department of Cardiology, Kurashiki Central Hospital
| | | | - Ryosuke Murai
- Department of Cardiology, Kurashiki Central Hospital
| | - Takeshi Tada
- Department of Cardiology, Kurashiki Central Hospital
| | | | - Yasushi Fuku
- Department of Cardiology, Kurashiki Central Hospital
| | - Tsuyoshi Goto
- Department of Cardiology, Kurashiki Central Hospital
| | | |
Collapse
|
|
40
|
Dan K, Garcia-Garcia HM, Kolm P, Windecker S, Saito S, Kandzari DE, Waksman R. Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circ Cardiovasc Interv 2020; 13:e009189. [DOI: 10.1161/circinterventions.120.009189] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background:
The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis.
Methods:
From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES.
Results:
Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%;
P
<0.01) and target vessel myocardial infarction (4.2% versus 7.6%;
P
<0.01) were significantly lower in BP-SES than in DP-EES. No difference in the outcome between the stents was shown in patients with non-small vessel lesions. In patients with calcified lesions, target lesion failure (12.2% versus 6.9%;
P
=0.056), and cardiac death (1.9% versus 0.3%;
P
=0.081) were numerically higher in DP-EES than in BP-SES. In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES. Stent thrombosis was similar between the stents in both lesion groups.
Conclusions:
Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year.
Registration:
URL:
https://www.clinicaltrials.gov
. Unique identifiers: NCT01356888, NCT01939249, NCT02389946.
Collapse
Affiliation(s)
- Kazuhiro Dan
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.)
| | - Hector M. Garcia-Garcia
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.)
| | - Paul Kolm
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.)
| | - Stephan Windecker
- Department of Cardiology, Bern University Hospital, Switzerland (S.W.)
| | - Shigeru Saito
- Department of Cardiology, Shonan Kamakura General Hospital, Japan (S.S.)
| | | | - Ron Waksman
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.)
| |
Collapse
|
|
41
|
Mitsutake Y, Konishi A, Handa N, Ho M, Shirato H, Ito T, Koike K, Mochizuki S, Ishii K. Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System. Circ J 2020; 84:1568-1574. [PMID: 32684539 DOI: 10.1253/circj.cj-20-0133] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [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 Stent thrombosis (ST) is a serious complication after drug-eluting stents (DES) implantation. To identify the risk factors of mortality following ST, we evaluated adverse event reports used for safety measures after approval. METHODS AND RESULTS Between July 2004 and August 2019, 2,887 ST case reports were submitted to the Pharmaceutical and Medical Device Agency. Reports of probable or possible ST (n=604), with insufficient data regarding in-hospital outcome or duration between procedure and ST occurrence (n=37) or duplicate reports (n=191) were excluded. Accordingly, 2,045 reports with definite ST were analyzed. Among the subjects, there were 286 in-hospital deaths (14.0%). Multivariate logistic regression analysis revealed that left main trunk (LMT) (odds ratio [OR]: 4.76, 95% confidence interval [CI]: 3.26-6.96), chronic heart failure (CHF) (OR: 2.88, 95% CI: 1.61-5.14), hemodialysis (OR: 2.69, 95% CI: 1.66-4.36), prior stroke (OR: 2.28, 95% CI: 1.15-4.51), over 70 years old (OR: 1.62, 95% CI: 1.22-2.16), and right coronary artery (OR: 0.41, 95% CI: 0.27-0.63) were independent factors for in-hospital death after DES-ST. CONCLUSIONS LMT, CHF, hemodialysis, prior stroke, and older age were independently associated with higher risk of in-hospital death following DES-ST. If target patients have these factors, maximum preventive strategies against ST occurrence, including adequate dual-antiplatelet therapy duration and optimal DES deployment procedures, are required.
Collapse
Affiliation(s)
- Yoshiaki Mitsutake
- Division of Cardiovascular Medicine, Kurume University School of Medicine
| | - Akihide Konishi
- Clinical & Translational Research Center, Kobe University Hospital
| | - Nobuhiro Handa
- Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency
| | - Mami Ho
- Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency
| | - Haruki Shirato
- Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency
| | - Takuya Ito
- Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency
| | - Kazuhisa Koike
- Division of Safety for Medical Devices, Office of Manufacturing Quality and Vigilance for Medical Devices, Pharmaceuticals and Medical Devices Agency
| | - Shuichi Mochizuki
- Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency
| | - Kensuke Ishii
- Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency
| |
Collapse
|
|
42
|
Midterm Clinical Impacts of Biodegradable Polymer Everolimus-Eluting Stents Compared with Durable Polymer Everolimus-Eluting Stents: A 3-Year Propensity-Matched Study. J Interv Cardiol 2020; 2020:2869303. [PMID: 32395090 PMCID: PMC7191363 DOI: 10.1155/2020/2869303] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/24/2019] [Revised: 03/04/2020] [Accepted: 03/13/2020] [Indexed: 11/17/2022] Open
Abstract
Objectives Our aim was to evaluate the safety and efficacy of biodegradable polymer everolimus-eluting stents (BP-EES) compared with durable polymer everolimus-eluting stents (DP-EES) in midterm. Background There are few data about midterm clinical outcomes of BP-EES compared with DP-EES. Methods and Results Between January 2016 and December 2017, 395 consecutive patients were treated with BP-EES and 391 consecutive patients were treated with DP-EES in Nagoya Heart Center. The primary endpoint was a 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel myocardial infarction (MI), and clinical indicated target lesion revascularization (TLR). Moreover, clinical indicated target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated as the secondary endpoints. After propensity score matching, 327 patients were selected in each group. At 3 years, the cumulative incidence of TLF was 4.5% in the BP-EES group versus 6.5% in DP-EES (adjusted HR 0.67 (95% CI 0.33–1.30), log-rank P=0.23). Regarding the individual components of the TLF at 3 years, the cumulative incidence of target vessel MI was significantly lower in BP-EES than in DP-EES (0% versus 1.9%: adjusted HR 0.83 (95% CI 0.71–0.97), log-rank P=0.01), but there was no difference between BP-EES and DP-EES in the incidence of cardiac death and clinically indicated TLR. The cumulative 3-year incidence of definite ST was significantly lower in BP-EES than in DP-EES (0% versus 1.6%, log-rank P=0.02). Conclusions There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in midterm.
Collapse
|
|
43
|
Dutra GVS, Neto WS, Dutra JPS, Machado F. Implantable Medical Devices and Tissue Engineering: An Overview of Manufacturing Processes and the Use of Polymeric Matrices for Manufacturing and Coating their Surfaces. Curr Med Chem 2020; 27:1580-1599. [PMID: 30215330 DOI: 10.2174/0929867325666180914110119] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2016] [Revised: 12/09/2016] [Accepted: 03/01/2017] [Indexed: 12/22/2022]
Abstract
Medical devices are important diagnosis and therapy tools for several diseases which include a wide range of products. Technological advances in this area have been proposed to reduce adverse complication incidences. New technologies and manufacturing processes, as well as the development of new materials or medical devices with modified surface and the use of biodegradable polymeric devices such as a substrate for cell culture in the field of tissue engineering, have attracted considerable attention in recent years by the scientific community intended to produce medical devices with superior properties and morphology. This review article focused on implantable devices, addresses the major advances in the biomedical field related to the devices manufacture processes such as 3D printing and hot melting extrusion, and the use of polymer matrices composed of copolymers, blends, nanocomposites or grafted with antiproliferative drugs for manufacturing and/or coating the devices surface.
Collapse
Affiliation(s)
- Gabriel Victor Simões Dutra
- Instituto de Quimica, Universidade de Brasilia, Campus Universitario Darcy Ribeiro, 70910-900 Brasília, DF, Brazil
| | - Weslany Silvério Neto
- Instituto de Quimica, Universidade de Brasilia, Campus Universitario Darcy Ribeiro, 70910-900 Brasília, DF, Brazil
| | - João Paulo Simões Dutra
- Departamento de Medicina, Pontificia Universidade Catolica de Goias, Avenida Universitaria 1440 Setor Universitario, 74605-070 Goiania, GO, Brazil
| | - Fabricio Machado
- Instituto de Quimica, Universidade de Brasilia, Campus Universitario Darcy Ribeiro, 70910-900 Brasília, DF, Brazil
| |
Collapse
|
|
44
|
Impact of bleeding events after percutaneous coronary intervention in patients on hemodialysis. Heart Vessels 2020; 35:1323-1330. [PMID: 32296926 DOI: 10.1007/s00380-020-01605-0] [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: 12/26/2019] [Accepted: 04/03/2020] [Indexed: 10/24/2022]
Abstract
Coronary artery disease is common in patients on dialysis; there is a high rate of bleeding events after percutaneous coronary intervention (PCI) in such patients. We investigated the impact of bleeding events after PCI on mortality in patients on hemodialysis. We included 386 consecutive hemodialysis patients who underwent PCI using a drug-eluting stent (DES) between September 2004 and December 2017 in our hospital, and investigated the impact of bleeding events on all-cause mortality after PCI. Bleeding events were assessed by the Thrombolysis in Myocardial Infarction (TIMI) bleeding definition within 24 months after PCI. A total of 42 patients experienced bleeding events. Of these, 30 patients (71.4%) had TIMI major bleeding events and 12 patients (28.6%) had TIMI minor bleeding events. Patients with bleeding events had significantly higher mortality than patients without bleeding events (survival rate, 55.1% vs 81.5%, log-rank: p < 0.001). These results suggest that bleeding events after PCI with a DES are notably associated with all-cause mortality among patients on hemodialysis. This is the first report about relationship between bleeding events and mortality to focus on patients on hemodialysis.
Collapse
|
|
45
|
Filatova AY, Romasov IV, Potekhina AV, Osokina AK, Noeva EA, Arefieva TI, Barabanova EA, Merkulov EV, Samko AN, Provatorov SI. The Incidence and Possible Predictors of Coronary Restenosis. ACTA ACUST UNITED AC 2020; 60:10-16. [DOI: 10.18087/cardio.2020.2.n621] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2020] [Accepted: 03/04/2020] [Indexed: 11/18/2022]
Abstract
Objective. Assess time and possible predictors of restenosis after the implantation of first- and second-generation coronary stents and bare metal stents (BMSs) in patients with stable coronary artery disease after elective coronary stenting.Materials and Methods. From 2010 to 2014, 3,732 (2,897 males, 60 [53; 68] years old) patients with stable exertional angina of functional class I–III underwent coronary stenting. From 2014 to 2017, 1,487 (1,173 males and 314 females) patients returned. Repeat coronary angiography was performed in 699 patients.Results. A total of 644 first-generation stents, 5,321 second-generation stents, and 473 BMSs were implanted. During the control coronary angiography, contrasting was repeated for 193 first-generation stents, 899 second-generation stents, and 77 BMSs. Restenosis (stenosis of 50 % or more in the previously stented segment) was detected in 28 (14 % of angiographic control) first-generation drug-eluting stents, 94 (10 %) second-generation drug-eluting stents, and 21 (27 %) BMSs. Patients with BMS restenosis returned significantly earlier than patients with restenosis of the first- and second-generation drug-eluting stents (11 [6, 27] months vs. 32 [11; 48]) months and 24 [12; 42] months, respectively; p<0.05). The initial and repeat levels of high-sensitivity C-reactive protein (hs-CRP) were higher in patients with restenosis (2.2 [1.2, 5.0] mg / L vs. 2.1 [1.0, 4.6] mg / L, respectively; p> 0.05) than in patients without restenosis (2.0 [0.9, 4.2] mg / L vs. 1.9 [0.7, 3.5] mg / L respectively, p>0.05). Blood levels of hs-CRP ≥2 mg / L according to receiver operating characteristic curve (ROC) analysis at return visit were used as a predictor to identify restenosis of stents with a diameter <3 mm and a length >25 mm – area under the curve (AUC) 0.67 (95 % confidence interval (CI) 0.51–0.84), p <0.05, odds ratio 3.7 (95 % CI 1.1–12.1), p<0.05. Stent type had a significant effect on the time to restenosis in the survival analysis (p<0.0005).Conclusion. The time from coronary stenting to the return visit of patients presenting with restenosis after the implantation of first- and second-generation drug-eluting stents is consistent; median time of the return visit of patients with restenosis of the first-generation stents was 2–3 years after coronary stenting. Blood levels of hs-CRP ≥2 mg / L at the return visit is a predictor of restenosis of stents with a diameter <3 mm and a length >25 mm.
Collapse
|
|
46
|
Konishi A, Mitsutake Y, Ho M, Handa N, Koike K, Mochizuki S, Ishii K. Patient and lesion characteristics in late/very late stent thrombosis with everolimus-eluting stents from real-world adverse event reporting. J Cardiol 2020; 75:255-260. [DOI: 10.1016/j.jjcc.2019.07.016] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/25/2019] [Revised: 07/11/2019] [Accepted: 07/28/2019] [Indexed: 11/16/2022]
|
|
47
|
Dai R, Liu Y, Zhou Y, Xiong X, Zhou W, Li W, Zhou W, Chen M. Potential of circulating pro-angiogenic microRNA expressions as biomarkers for rapid angiographic stenotic progression and restenosis risks in coronary artery disease patients underwent percutaneous coronary intervention. J Clin Lab Anal 2020; 34:e23013. [PMID: 31495986 PMCID: PMC6977144 DOI: 10.1002/jcla.23013] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2019] [Revised: 08/05/2019] [Accepted: 08/07/2019] [Indexed: 12/13/2022] Open
Abstract
BACKGROUND This study aimed to investigate the correlation of pro-angiogenic microRNA (miRNA) expressions with rapid angiographic stenotic progression (RASP) and restenosis risks in coronary artery disease (CAD) patients underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS A total of 286 CAD patients underwent PCI with DES were consecutively recruited in this study. Plasma samples were collected before PCI operation, and 14 pro-angiogenic miRNAs were measured by real-time quantitative reverse transcription-polymerase chain reaction. Rapid angiographic stenotic progression at nontarget lesions and restenosis at stented lesions were evaluated by quantitative coronary angiography at 12 months after PCI operation. RESULTS The occurrence rates of RASP and restenosis were 39.5% and 22.4%, respectively. Let-7f, miR-19a, miR-19b-1, miR-92a, miR-126, miR-210, and miR-296 were decreased in RASP patients than non-RASP patients, among which let-7f, miR-19a, miR-126, miR-210, and miR-296 independently correlated with lower RASP occurrence by multivariate analysis, followed by receiver-operating characteristic (ROC) curve exhibited that these five miRNAs showed great value in predicting RASP risk with area under curve (AUC) 0.879 (95% CI: 0.841-0.917). Besides, let-7f, miR-19a, miR-92a, miR-126, miR-130a, and miR-210 were reduced in restenosis patients than non-restenosis patients, among them miR-19a, miR-126, miR-210, and miR-378 independently correlated with lower restenosis occurrence by multivariate analysis, followed by ROC curve disclosed that these four miRNAs had good value in predicting restenosis risk with AUC 0.776 (95% CI: 0.722-0.831). CONCLUSIONS Circulating let-7f, miR-19a, miR-126, miR-210, and miR-296 independently correlate with reduced RASP risk, while miR-19a, miR-126, miR-210, and miR-378 independently correlate with decreased restenosis risk in CAD patients underwent PCI with DES.
Collapse
Affiliation(s)
- Rui Dai
- Department of Cardiology, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| | - Yijue Liu
- Emergency Department, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| | - Yi Zhou
- Department of Cardiology, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| | - Xiaoju Xiong
- Department of Cardiology, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| | - Wei Zhou
- Department of Cardiology, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| | - Weijuan Li
- Department of Cardiology, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| | - Wenping Zhou
- Department of Cardiology, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| | - Manhua Chen
- Department of Cardiology, Tongji Medical CollegeThe Central Hospital of Wuhan, Huazhong University of Science & TechnologyWuhanChina
| |
Collapse
|
|
48
|
Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study. J Interv Cardiol 2019; 2019:3146848. [PMID: 31777468 PMCID: PMC6874987 DOI: 10.1155/2019/3146848] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2019] [Revised: 08/13/2019] [Accepted: 10/01/2019] [Indexed: 02/01/2023] Open
Abstract
Background The long-term safety of first-generation drug-eluting stent (DES) in acute coronary syndrome (ACS) was controversial. Purpose The purpose of this study was to establish 5-year real-world data regarding the long-term efficacy and safety of second-generation DES in Japanese patients with ACS. Methods The Tokyo-MD PCI study is a multicenter, observational cohort study enrolling consecutive patients who underwent everolimus-eluting stent (EES) implantation. The 5-year clinical events were compared between the ACS group (n = 644) and the stable coronary artery disease (SCAD) group (n = 1255). The primary efficacy endpoint was ischemia-driven target lesion revascularization (TLR), and the primary safety endpoint was the composite of all-cause death or myocardial infarction (MI). Results The median follow-up duration was 5.4 years. The cumulative incidence of ischemia-driven TLR was similar between ACS and SCAD (1 year: 3.0% versus 2.7%; P=0.682, 1-5 years: 2.7% versus 2.9%; P=0.864). The cumulative incidence of all-cause death or MI within 1 year was significantly higher in ACS than in SCAD (7.4% versus 3.8%; P < 0.001); however, ACS did not increase the risk of all-cause death or MI after adjusting confounders (adjusted hazard ratio, 1.260; 95% confidence interval, 0.774-2.053; P=0.352). From 1 to 5 years, the cumulative incidence of all-cause death or MI was not significantly different between ACS and SCAD (11.6% versus 11.4%; P=0.706). The cumulative incidence of very late stent thrombosis was low and similar between ACS and SCAD (0.2% versus 0.2%; P=0.942). Conclusion This real-world registry suggested that EES has comparable long-term efficacy and safety in patients with ACS and SCAD.
Collapse
|
|
49
|
Kufner S, Joner M, Thannheimer A, Hoppmann P, Ibrahim T, Mayer K, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, Byrne RA. Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease. Circulation 2019; 139:325-333. [PMID: 30586724 DOI: 10.1161/circulationaha.118.038065] [Citation(s) in RCA: 108] [Impact Index Per Article: 18.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up. METHODS Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients. RESULTS The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES. CONCLUSIONS In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676.
Collapse
Affiliation(s)
- Sebastian Kufner
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.)
| | - Michael Joner
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.).,German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance (M.J., K.-L.L., H.S., A.K., R.A.B.)
| | - Anna Thannheimer
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.)
| | - Petra Hoppmann
- 1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich (P.H., T.I., K.-L.L.)
| | - Tareq Ibrahim
- 1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich (P.H., T.I., K.-L.L.)
| | - Katharina Mayer
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.)
| | - Salvatore Cassese
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.)
| | - Karl-Ludwig Laugwitz
- 1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich (P.H., T.I., K.-L.L.).,German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance (M.J., K.-L.L., H.S., A.K., R.A.B.)
| | - Heribert Schunkert
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.).,German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance (M.J., K.-L.L., H.S., A.K., R.A.B.)
| | - Adnan Kastrati
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.).,German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance (M.J., K.-L.L., H.S., A.K., R.A.B.)
| | - Robert A Byrne
- Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.).,German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance (M.J., K.-L.L., H.S., A.K., R.A.B.)
| | | |
Collapse
|
|
50
|
Choudhury A, Garg S, Smith J, Sharp A, Nabais de Araujo S, Chauhan A, Patel N, Wrigley B, Chattopadhyay S, Zaman AG. Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months' results from the S-FLEX UK registry. BMJ Open 2019; 9:e026578. [PMID: 31604782 PMCID: PMC6797413 DOI: 10.1136/bmjopen-2018-026578] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/03/2022] Open
Abstract
OBJECTIVE To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in 'real world' patient population requiring percutaneous coronary intervention (PCI). METHODS National, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months-overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE-composite of cardiac death, MI, emergent or repeat revascularisation). RESULTS At 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%). CONCLUSIONS The S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.
Collapse
Affiliation(s)
- Anirban Choudhury
- Department of Cardiology, Cardiff and Vale University Health Board, Cardiff, UK
| | - Scot Garg
- Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK
| | - Jamie Smith
- Department of Cardiology, Raigmore Hospital, Inverness, UK
| | - Andrew Sharp
- Department of Cardiology, Royal Devon and Exeter Hospital, Exeter, UK
| | | | - Anoop Chauhan
- Department of Cardiology and Institute of Cellular Medicine, Blackpool Victoria Hospital, Blackpool, UK
| | - Nikhil Patel
- Department of Cardiology, Eastbourne District General Hospital, Eastbourne, UK
| | - Benjamin Wrigley
- Department of Cardiology, The Heart and Lung Centre, Wolverhampton, UK
| | - Sudipta Chattopadhyay
- Department of Cardiology, Milton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK
| | | |
Collapse
|