Clopidogrel versus Aspirin Monotherapy Beyond 1 Year After PCI: STOPDAPT-2 5-Year Results.

P2Y(12) inhibition antiplatelet therapy bleeding coronary stent percutaneous coronary intervention

Journal

Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365

Informations de publication

Date de publication:
18 Oct 2023
Historique:
received: 07 10 2023
accepted: 13 10 2023
medline: 26 10 2023
pubmed: 26 10 2023
entrez: 25 10 2023
Statut: aheadofprint

Résumé

It remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). We compared clopidogrel monotherapy following 1-month DAPT (clopidogrel group) with aspirin monotherapy following 12-month DAPT (aspirin group) after PCI for 5 years. STOPDAPT-2 is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding). Among 3005 study patients (Age: 68.6±10.7 years; Women: 22.3%; Acute coronary syndrome: 38.3%), 2934 patients (97.6%) completed 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). Clopidogrel group compared with aspirin group was noninferior, but not superior for the primary endpoint (11.75% and 13.57%; HR 0.85 [95%CI: 0.70-1.05], P Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1-year after PCI.

Sections du résumé

BACKGROUND BACKGROUND
It remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).
OBJECTIVES OBJECTIVE
We compared clopidogrel monotherapy following 1-month DAPT (clopidogrel group) with aspirin monotherapy following 12-month DAPT (aspirin group) after PCI for 5 years.
METHODS METHODS
STOPDAPT-2 is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding).
RESULTS RESULTS
Among 3005 study patients (Age: 68.6±10.7 years; Women: 22.3%; Acute coronary syndrome: 38.3%), 2934 patients (97.6%) completed 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). Clopidogrel group compared with aspirin group was noninferior, but not superior for the primary endpoint (11.75% and 13.57%; HR 0.85 [95%CI: 0.70-1.05], P
CONCLUSIONS CONCLUSIONS
Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1-year after PCI.

Identifiants

pubmed: 37879491
pii: S0735-1097(23)07750-1
doi: 10.1016/j.jacc.2023.10.013
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Auteurs

Hirotoshi Watanabe (H)

Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.

Takeshi Morimoto (T)

Department of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, Japan.

Masahiro Natsuaki (M)

Department of Cardiovascular Medicine, Saga University, Saga, Japan.

Ko Yamamoto (K)

Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.

Yuki Obayashi (Y)

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Ryusuke Nishikawa (R)

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Kenji Ando (K)

Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.

Koh Ono (K)

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Kazushige Kadota (K)

Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.

Satoru Suwa (S)

Department of Cardiology, Juntendo University Shizuoka Hospital, Izunokuni, Japan.

Itsuro Morishima (I)

Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan.

Ruka Yoshida (R)

Department of Cardiology, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Japan.

Yoshiki Hata (Y)

Department of Cardiology, Minamino Cardiovascular Hospital, Hachioji, Japan.

Masaharu Akao (M)

Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.

Masahiro Yagi (M)

Department of Cardiology, Sendai Cardiovascular Center, Sendai, Japan.

Nobuhiro Suematsu (N)

Department of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.

Yoshihiro Morino (Y)

Department of Cardiology, Iwate Medical University Hospital, Yahaba, Japan.

Takafumi Yokomatsu (T)

Department of Cardiology, Mitsubishi Kyoto Hospital, Kyoto, Japan.

Itaru Takamisawa (I)

Department of Cardiology, Sakakibara Heart Institute, Fuchu, Japan.

Toshiyuki Noda (T)

Department of Cardiology, Gifu Prefectural General Medical Center, Gifu, Japan.

Masayuki Doi (M)

Department of Cardiology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.

Hideki Okayama (H)

Department of Cardiology, Ehime Prefectural Central Hospital, Matsuyama, Japan.

Yuichi Nakamura (Y)

Department of Cardiology, Hoshi General Hospital, Koriyama, Japan.

Kiyoshi Hibi (K)

Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.

Hiroki Sakamoto (H)

Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan.

Teruo Noguchi (T)

Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.

Takeshi Kimura (T)

Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan;. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.

Classifications MeSH