Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial.

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan. Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan. Department of Cardiovascular Medicine, Saga University, Saga, Japan. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan. Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan. Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan. Department of Cardiology, Sakakibara Heart Institute, Fuchu, Japan. Department of Cardiology, Minamino Cardiovascular Hospital, Hachioji, Japan. Department of Cardiology, Sendai Cardiovascular Center, Sendai, Japan. Department of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan. Department of Cardiology, Mitsubishi Kyoto Hospital, Kyoto, Japan. Department of Cardiology, Kagawa Prefectural Central Hospital, Takamatsu, Japan. Department of Cardiology, Gifu Prefectural General Medical Center, Gifu, Japan. Department of Cardiology, Ehime Prefectural Central Hospital, Matsuyama, Japan. Department of Cardiology, Hoshi General Hospital, Koriyama, Japan. Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan. Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan. Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. Department of Cardiology, Chikamori Hospital, Kochi, Japan. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan. Department of Cardiology, Tokai University Hospital, Isehara, Japan. Hanaoka Seishu Memorial Cardiovascular Clinic, Sapporo, Japan. Department of Cardiology, Iwate Medical University Hospital, Morioka, Japan. Department of Cardiology, Teikyo University Hospital, Tokyo, Japan. Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Japan. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. taketaka@kuhp.kyoto-u.ac.jp.

Cardiovascular intervention and therapeutics. 2021;(1):91-103

Abstract

Previously we briefly reported the effect of 1-month dual antiplatelet therapy (DAPT) for patients with high bleeding risk (HBR) receiving percutaneous coronary intervention (PCI) in the STOPDAPT-2 trial, but full analysis data have not been available. We conducted post hoc subgroup analysis regarding the effect of very short DAPT for HBR patients in STOPDAPT-2 trial. The primary endpoint was a 1-year composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and bleeding (TIMI major/minor bleeding) outcomes. Major secondary endpoints were 1-year cardiovascular composite endpoint and bleeding endpoint. HBR was defined by the academic research consortium (ARC) HBR criteria. Among the 3009 study patients, 1054 (35.0%) were classified as HBR and 1955 (65.0%) were as non-HBR. There were no significant interactions between HBR/non-HBR subgroups and the assigned DAPT group on the primary endpoint (HBR; 3.48% vs. 5.98%, HR 0.57, 95% CI 0.32-1.03, and non-HBR; 1.81% vs. 2.36%, HR 0.78, 95% CI 0.42-1.45; P for interaction = 0.48), the major secondary cardiovascular endpoint (HBR; 3.07% vs. 4.03%, HR 0.77, 95% CI 0.40-1.48, and non-HBR; 1.41% vs. 1.61%, HR 0.89, 95% CI 0.43-1.84; P for interaction = 0.77), and the major secondary bleeding endpoint (HBR; 0.41% vs. 2.71%, HR 0.15, 95% CI 0.03-0.65, and non-HBR; 0.40% vs. 0.85%, HR 0.48, 95% CI 0.14-1.58; P for interaction = 0.22). In conclusion, the effects of 1-month DAPT for the primary and major secondary endpoints were consistent in HBR and non-HBR patients without any significant interactions. The benefit of 1-month DAPT in reducing major bleeding was numerically greater in HBR patients.Clinical trial registration Short and optimal duration of dual antiplatelet therapy after everolimus-eluting cobalt-chromium stent-2 [STOPDAPT-2]; NCT02619760.

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