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Randomized Controlled Trial
. 2024 Jan 2;83(1):17-31.
doi: 10.1016/j.jacc.2023.10.013. Epub 2023 Oct 23.

Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention

Hirotoshi Watanabe  1 , Takeshi Morimoto  2 , Masahiro Natsuaki  3 , Ko Yamamoto  4 , Yuki Obayashi  5 , Ryusuke Nishikawa  5 , Kenji Ando  4 , Koh Ono  5 , Kazushige Kadota  6 , Satoru Suwa  7 , Itsuro Morishima  8 , Ruka Yoshida  9 , Yoshiki Hata  10 , Masaharu Akao  11 , Masahiro Yagi  12 , Nobuhiro Suematsu  13 , Yoshihiro Morino  14 , Takafumi Yokomatsu  15 , Itaru Takamisawa  16 , Toshiyuki Noda  17 , Masayuki Doi  18 , Hideki Okayama  19 , Yuichi Nakamura  20 , Kiyoshi Hibi  21 , Hiroki Sakamoto  22 , Teruo Noguchi  23 , Takeshi Kimura  24 ; STOPDAPT-2 Investigators
Affiliations
Free article
Randomized Controlled Trial

Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention

Hirotoshi Watanabe et al. J Am Coll Cardiol. .
Free article

Abstract

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: This study compared clopidogrel monotherapy following 1 month of DAPT (clopidogrel group) with aspirin monotherapy following 12 months of DAPT (aspirin group) after PCI for 5 years.

Methods: STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy 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: Among 3,005 study patients (age: 68.6 ± 10.7 years; women: 22.3%; acute coronary syndrome: 38.3%), 2,934 patients (97.6%) completed the 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). The clopidogrel group compared with the aspirin group was noninferior but not superior for the primary endpoint (11.75% and 13.57%, respectively; HR: 0.85; 95% CI: 0.70-1.05; Pnoninferiority < 0.001; Psuperiority = 0.13), whereas it was superior for the cardiovascular outcomes (8.61% and 11.05%, respectively; HR: 0.77; 95% CI: 0.61-0.97; P = 0.03) and not superior for major bleeding (4.44% and 4.92%, respectively; HR: 0.89; 95% CI: 0.64-1.25; P = 0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%, respectively; HR: 0.77; 95% CI: 0.59-1.01; P = 0.06) without difference in major bleeding (3.99% and 3.32%, respectively; HR: 1.23; 95% CI: 0.84-1.81; P = 0.31).

Conclusions: Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI.

Keywords: P2Y(12) inhibition; antiplatelet therapy; bleeding; coronary stent; percutaneous coronary intervention.

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Conflict of interest statement

Funding Support and Author Disclosures STOPDAPT-2 is funded by Abbott. The funder had no role in the design, data analysis, interpretation, or writing of the report. Dr Watanabe has received personal fees from Abbott; and has received personal fees from Amgen, Pfizer, and Daiichi-Sankyo outside the submitted work. Dr Morimoto has received lecturer’ fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Japan Lifeline, Kowa, Pfizer, and Tsumura; has received manuscript fees from Bristol Myers Squibb and Pfizer; and has served on the Advisory Board for Novartis and Teijin outside the submitted work. 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 Hibi has received a scholarship donation from Abbott. Dr Kimura has received research grants from Abbott Vascular and Boston Scientific; and serves as an Advisory Board member for Abbott Vascular 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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