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Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention
Institution:1. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan;2. Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan;3. Department of Cardiovascular Medicine, Saga University, Saga, Japan;4. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan;5. Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan;6. Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan;7. Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan;8. Department of Cardiology, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan;9. Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan;10. Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan;11. Department of Cardiology, Minamino Cardiovascular Hospital, Hachioji, Japan;12. Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan;13. Department of Cardiology, Sendai Cardiovascular Center, Sendai, Japan;14. Department of Cardiology, Showa University Fujigaoka Hospital, Yokohama, Japan;15. Department of Cardiology, Showa University Koto Toyosu Hospital, Tokyo, Japan;p. Division of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan;q. Division of Cardiology, Cardiovascular Center, Osaka Red Cross Hospital, Osaka, Japan;r. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan;s. Department of Cardiology, Ehime Prefectural Central Hospital, Matsuyama, Japan;t. Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan
Abstract:BackgroundDiabetes was reported to be associated with an impaired response to clopidogrel.ObjectivesThe aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI).MethodsA subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year.ResultsThere were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; Pinteraction = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; Pinteraction = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; Pinteraction = 0.19).ConclusionsClopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS STOPDAPT-2 ACS], NCT03462498)
Keywords:antiplatelet therapy  coronary stent(s)  diabetes  percutaneous coronary intervention  ARC"}  {"#name":"keyword"  "$":{"id":"kwrd0035"}  "$$":[{"#name":"text"  "_":"Academic Research Consortium  CYP2C19"}  {"#name":"keyword"  "$":{"id":"kwrd0045"}  "$$":[{"#name":"text"  "_":"cytochrome P450 2C19  DAPT"}  {"#name":"keyword"  "$":{"id":"kwrd0055"}  "$$":[{"#name":"text"  "_":"dual antiplatelet therapy  HBR"}  {"#name":"keyword"  "$":{"id":"kwrd0065"}  "$$":[{"#name":"text"  "_":"high bleeding risk  LOF"}  {"#name":"keyword"  "$":{"id":"kwrd0075"}  "$$":[{"#name":"text"  "_":"loss-of-function  PCI"}  {"#name":"keyword"  "$":{"id":"kwrd0085"}  "$$":[{"#name":"text"  "_":"percutaneous coronary intervention
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