Over 10 years post-PCI, clopidogrel monotherapy significantly reduced the primary composite endpoint compared to aspirin (25.4% vs 28.5%; HR 0.86; 95% CI 0.77-0.96; p=0.0050).
RCT (n=5,438)
Does clopidogrel reduce the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC type ≥3 bleeding compared to aspirin in patients who completed event-free dual antiplatelet therapy for 6-18 months after PCI?
Over a 10-year follow-up, clopidogrel monotherapy was superior to aspirin monotherapy in reducing the composite of ischemic and bleeding events during the chronic maintenance phase after PCI.
Effect estimate: HR 0.86 (95% CI 0.77-0.96)
Absolute Event Rate: 25.4% vs 28.5%
p-value: p=0.0050
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 10·5 years (IQR 9·4-11·4) after PCI and a completion rate of 92·8%. Clopidogrel was associated with a lower rate of the primary composite endpoint than aspirin (Kaplan-Meier estimate 25·4% for the clopidogrel group vs 28·5% for the aspirin group; hazard ratio 0·86 95% CI 0·77-0·96; log-rank p=0·0050). Clopidogrel was also associated with a lower rate of the thrombotic endpoint (17·3% vs 20·0%; log-rank p=0·0024) and bleeding endpoint (9·1% vs 10·8%; log-rank p=0·020). 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.
“These findings suggest that clopidogrel might be considered as a preferred agent for long-term antiplatelet monotherapy during the chronic maintenance phase after PCI. The substantial reduction in the cost of clopidogrel over the past three decades, together with the positive long-term results from the current study, warrants a reappraisal of the benefits of clopidogrel over aspirin.”
Kang et al. (2026) conducted an RCT in Post-percutaneous coronary intervention (PCI) (n=5,438). Clopidogrel vs. Aspirin 100 mg once daily was evaluated on Composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium type ≥3 bleeding (HR 0.86, 95% CI 0.77-0.96, p=0.0050). Over 10 years post-PCI, clopidogrel monotherapy significantly reduced the primary composite endpoint compared to aspirin (25.4% vs 28.5%; HR 0.86; 95% CI 0.77-0.96; p=0.0050).