Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention: 10-year follow-up of the HOST-EXAM trial

초록

Background The long-term clinical outcomes of clopidogrel monotherapy versus aspirin monotherapy after percutaneous coronary intervention (PCI) remain uncertain. We conducted a 10-year follow-up of the HOST-EXAM trial to assess the very long-term effects of clopidogrel versus aspirin monotherapy in this setting. Methods In HOST-EXAM, patients who had completed dual antiplatelet therapy without clinical events for 6-18 months after PCI were randomly assigned to receive clopidogrel 75 mg once daily or aspirin 100 mg once daily. This study is an investigator-initiated 10-year extended follow-up of the HOST-EXAM trial. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium type >= 3 bleeding. The primary analysis was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov (NCT02044250) and is complete. Findings From March 26, 2014, to May 29, 2018, 5530 patients were enrolled and 5438 were randomly assigned to the aspirin group (n=2728) or the clopidogrel group (n=2710). Clinical follow-up status was ascertained on May 1, 2025, resulting in a median follow-up duration of 10 & centerdot;5 years (IQR 9 & centerdot;4-11 & centerdot;4) after PCI and a completion rate of 92 & centerdot;8%. Clopidogrel was associated with a lower rate of the primary composite endpoint than aspirin (Kaplan-Meier estimate 25 & centerdot;4% for the clopidogrel group vs 28 & centerdot;5% for the aspirin group; hazard ratio 0 & centerdot;86 [95% CI 0 & centerdot;77-0 & centerdot;96]; log-rank p=0 & centerdot;0050). Clopidogrel was also associated with a lower rate of the thrombotic endpoint (17 & centerdot;3% vs 20 & centerdot;0%; log-rank p=0 & centerdot;0024) and bleeding endpoint (9 & centerdot;1% vs 10 & centerdot;8%; log-rank p=0 & centerdot;020). All-cause mortality was similar between groups. Interpretation During 10 years of follow-up, clopidogrel monotherapy, compared with aspirin monotherapy, was associated with lower rates of the primary composite, ischaemic, and bleeding outcomes, but not all-cause mortality after PCI. These findings support consideration of clopidogrel as an alternative to aspirin for long-term antiplatelet monotherapy during the chronic maintenance phase after PCI. Funding Ministry of Health & Welfare, South Korea. Copyright (c) 2026 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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