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Clinical Trial
. 2025 Sep 8;18(17):2120-2135.
doi: 10.1016/j.jcin.2025.03.029. Epub 2025 Jun 4.

Aspirin vs Clopidogrel 1 Month After Acute Coronary Syndrome With High-Bleeding Risk or ST-Segment Elevation

Yuki Obayashi  1 , Masahiro Natsuaki  2 , Hirotoshi Watanabe  3 , Takeshi Morimoto  4 , Ko Yamamoto  5 , Ryusuke Nishikawa  1 , Tomoya Kimura  6 , Kenji Ando  5 , Satoru Suwa  7 , Tsuyoshi Isawa  8 , Hiroyuki Takenaka  3 , Tetsuya Ishikawa  9 , Hideo Tokuyama  10 , Hiroki Sakamoto  11 , Takanari Fujita  12 , Mamoru Nanasato  13 , Hideki Okayama  14 , Tenjin Nishikura  15 , Hidekuni Kirigaya  16 , Koji Nishida  17 , Koh Ono  1 , Takeshi Kimura  18 ; STOPDAPT-3 Investigators
Affiliations
Clinical Trial

Aspirin vs Clopidogrel 1 Month After Acute Coronary Syndrome With High-Bleeding Risk or ST-Segment Elevation

Yuki Obayashi et al. JACC Cardiovasc Interv. .

Abstract

Background: High bleeding risk (HBR) and acute coronary syndrome (ACS) subtypes (ST-segment elevation myocardial infarction [STEMI] and non-ST-segment elevation ACS [NSTE-ACS]) might be key determinants of appropriate antiplatelet strategies.

Objectives: The aim of this study was to investigate the effects of aspirin versus clopidogrel within 1 year after percutaneous coronary intervention in patients with ACS, on the basis of HBR or non-HBR and STEMI or NSTE-ACS.

Methods: Patients with ACS in the STOPDAPT-3 (Short and Optimal Duration of Dual Antiplatelet Therapy-3) trial were included. Aspirin and clopidogrel monotherapy were compared beyond 30 days and up to 1 year in the prespecified subgroups stratified by HBR or non-HBR and STEMI or NSTE-ACS. The coprimary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke; the coprimary bleeding endpoint was major bleeding (Bleeding Academic Research Consortium type 3 or 5).

Results: Among 4,353 patients, 1,711 had HBR and 2,457 had STEMI. Throughout the 335-day follow-up period, the crude HRs for aspirin compared with clopidogrel were not statistically significant for cardiovascular endpoints in both the HBR or non-HBR (HR: 0.89 [95% CI: 0.61-1.30] and HR: 1.08 [95% CI: 0.61-1.90]; P for interaction = 0.59) and STEMI or NSTE-ACS (HR: 1.01 [95% CI: 0.68-1.50] and HR: 0.81 [95% CI: 0.48-1.37]; P for interaction = 0.51) subgroups. Similarly, the HRs for bleeding endpoints were not significant in both the HBR or non-HBR (HR: 0.73 [95% CI: 0.40-1.33] and HR: 0.71 [95% CI: 0.23-2.24]; P for interaction = 0.97) and STEMI or NSTE-ACS (HR: 0.96 [95% CI: 0.46-2.01] and HR: 0.53 [95% CI: 0.24-1.17]; P for interaction = 0.28) subgroups.

Conclusions: In patients with ACS, aspirin and clopidogrel demonstrated comparable effects on both cardiovascular and bleeding outcomes beyond 1 month and up to 1 year after percutaneous coronary intervention, irrespective of HBR or non-HBR and STEMI or NSTE-ACS. (Short and Optimal Duration of Dual Antiplatelet Therapy-3 Study [STOPDAPT-3]; NCT04609111).

Keywords: ST-segment elevation myocardial infarction; acute coronary syndrome(s); antiplatelet therapy; high bleeding risk; non–ST-segment elevation acute coronary syndrome(s).

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Conflict of interest statement

Funding Support and Author Disclosures This work was supported by Abbott Vascular Japan. Dr Obayashi has received lecture fees from Abbott Medical Japan. Dr Natsuaki has received honoraria from Abbott Medical Japan, Daiichi-Sankyo, Medtronic, Terumo, Japan Lifeline, Asahi Intecc, Bristol Myers Squibb, Otsuka, Amgen, Sanofi, Takeda, and Bayer. Dr Watanabe received personal fees from Abbott Medical Japan during the conduct of the study; and has received personal fees from Daiichi-Sankyo, Kowa, Abiomed, Bayer, Pfizer, Bristol Myers Squibb, and Otsuka, outside the submitted work. Dr Morimoto has received lectures fees from AstraZeneca, Bristol Myers Squibb, Daiichi-Sankyo, Japan Lifeline, Kowa, Pfizer, and Tsumura; has received manuscript fees from Bristol Myers Squibb and Pfizer; and is an advisory board member for Novartis and Teijin. Dr Yamamoto has received honoraria from Abbott Medical Japan, Daiichi-Sankyo, and Boston Scientific. Dr Suwa has received personal fees from Abbott Medical Japan and Daiichi-Sankyo, outside the submitted work. Dr Takeshi Kimura has received grants from Abbott Medical Japan and Boston Scientific; and is an advisory board member for Abbott Medical Japan and Terumo Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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