Key result
Long-term P2Y12 inhibitor monotherapy shows no benefit over aspirin for net adverse clinical events after PCI.
Why the study?
Optimal long-term antiplatelet monotherapy after PCI for ACS remains debated, and whether different P2Y12 inhibitors provide comparable clinical benefits as long-term monotherapy was unclear.
Does long-term monotherapy with clopidogrel or prasugrel reduce net adverse clinical events (thromboembolism, major bleeding, and all-cause death) compared with aspirin monotherapy in patients with acute coronary syndrome after percutaneous coronary intervention and at least 6 months of DAPT?
Cohort (n=109,077)
Yes
Does long-term monotherapy with clopidogrel or prasugrel reduce net adverse clinical events (thromboembolism, major bleeding, and all-cause death) compared with aspirin monotherapy in patients with acute coronary syndrome after percutaneous coronary intervention and at least 6 months of DAPT?
In a large nationwide Japanese cohort of ACS patients post-PCI, long-term monotherapy with clopidogrel or low-dose prasugrel showed no significant difference in net adverse clinical events compared with aspirin, though prasugrel was associated with lower thromboembolic risk without increased major bleeding.
Comparable NACE with clopidogrel or prasugrel versus aspirin; does not support practice change and leaves open randomized confirmation.
Background Optimal long-term antiplatelet monotherapy in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) remains a subject of ongoing debate. In particular, it remains unclear whether different P2Y12 inhibitors provide comparable clinical benefits when used as long-term monotherapy. We investigated the efficacy and safety of antiplatelet monotherapy following dual antiplatelet therapy (DAPT) in patients with ACS, using a Japanese nationwide administrative claims database. Methods This retrospective study included patients with ACS who underwent PCI with drug-eluting stent implantation and received antiplatelet monotherapy after a minimum of 6 months of DAPT between April 2014 and March 2020. Net adverse clinical events (NACE), a composite of thromboembolism, major bleeding, and all-cause death, were compared between patients receiving clopidogrel 75 mg or prasugrel 3.75 mg and those receiving aspirin 75–100 mg using an inverse probability of treatment weighting (IPTW) analysis. Results Of the 109,077 patients included, 50,189 (46.0%) were aged 70 years and older, and 25,123 (23.0%) were female. Of these, 19,479 (17.9%), 9,067 (8.3%), and 80,531 (73.8%) patients received clopidogrel, prasugrel, and aspirin monotherapy, respectively. With a median (IQR) follow-up of 1,542 (1,071–2,092) days after the index PCI, NACE occurred in 1,423 patients (3.53 per 100 person-years) in the clopidogrel group, 408 patients (2.68 per 100 person-years) in the prasugrel group, and 5,490 patients (3.05 per 100 person-years) in the aspirin group after the 18-month landmark period. The IPTW-adjusted hazard ratio (HR) of NACE was 1.03 (95% confidence interval [CI]: 0.96–1.10, p=0.40) in the clopidogrel group and 1.01 (95% CI: 0.89–1.14, p=0.92) in the prasugrel group compared with the aspirin group. The prasugrel group showed a lower hazard ratio of thromboembolism (HR: 0.74 [95% CI: 0.60–0.92], p=0.008) and no differences in major bleeding event (HR: 1.13 [95% CI: 0.87–1.48]). Conclusions In patients after PCI for ACS, long-term monotherapy with clopidogrel or prasugrel showed no significant difference in NACE compared with aspirin. Prasugrel use was associated with a lower risk of thromboembolic events without an increased risk of severe bleeding.
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Iwanaga et al. (2026) conducted a cohort in Acute coronary syndrome following percutaneous coronary intervention (n=109,077). Clopidogrel or prasugrel monotherapy vs. Aspirin 75–100 mg monotherapy was evaluated on Net adverse clinical events (NACE), a composite of thromboembolism, major bleeding, and all-cause death (HR 1.03, 95% CI 0.96-1.10, p=0.40). Long-term clopidogrel (HR 1.03; 95% CI 0.96-1.10) or prasugrel (HR 1.01; 95% CI 0.89-1.14) monotherapy showed no difference in net adverse clinical events vs aspirin after PCI for ACS.
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