Key result
Clopidogrel monotherapy cuts death, MI, or stroke ~55% vs aspirin in females, with consistent male benefit.
Why the study?
The optimal antiplatelet strategy according to sex after PCI remains controversial.
Does clopidogrel monotherapy reduce the composite of all-cause death, myocardial infarction, or stroke compared to aspirin monotherapy in male and female patients at high risk of recurrent ischemic events after completing standard DAPT post-PCI?
RCT (n=5,506)
randomly assigned
Does clopidogrel monotherapy reduce the composite of all-cause death, myocardial infarction, or stroke compared to aspirin monotherapy in male and female patients at high risk of recurrent ischemic events after completing standard DAPT post-PCI?
Hazard Ratio: 0.45 (95% CI 0.24–0.85)
Absolute Event Rate: 4.3% vs 9.4%
p-value: p=0.014
Clopidogrel monotherapy shows a consistent reduction in ischemic events compared to aspirin monotherapy in both male and female patients after PCI, with no significant sex-by-treatment interaction.
Substudy suggests no sex interaction for clopidogrel benefit; underpowered for women, leaves generalizability open.
BACKGROUND: Clopidogrel has emerged as a promising alternative to aspirin monotherapy for maintenance therapy after percutaneous coronary intervention (PCI); however, the optimal antiplatelet strategy according to sex remains controversial. AIMS: We aimed to investigate whether the treatment effect of antiplatelet therapy differs according to sex. METHODS: This study was a prespecified substudy of the SMART-CHOICE 3 trial. Patients at high risk of recurrent ischaemic events who had completed the standard duration of dual antiplatelet therapy after PCI were randomly assigned to receive clopidogrel or aspirin monotherapy. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke. RESULTS: A total of 5,506 patients, including 1,002 females and 4,504 males, were enrolled in South Korea. Females had a higher risk profile than males; however, the incidence of the primary endpoint did not differ significantly between females and males (6.7% vs 5.2%, adjusted hazard ratio [HR] 0.89, 95% confidence interval [CI]: 0.62-1.28; p=0.537). Clopidogrel, compared with aspirin, significantly reduced the primary endpoint in females (4.3% vs 9.4%, adjusted HR 0.45, 95% CI: 0.24-0.85; p=0.014) but not in males (4.4% vs 6.0%, adjusted HR 0.77, 95% CI: 0.56-1.07; p=0.116). There was no significant interaction between sex and the antiplatelet therapy (p for interaction=0.288). CONCLUSIONS: In patients with remote PCI and a high risk of recurrent ischaemic events, clopidogrel monotherapy showed a directionally consistent reduction in the composite endpoint of all-cause death, myocardial infarction, or stroke compared with aspirin in both females and males. No significant sex-by-treatment interaction was observed, supporting the consistency of the treatment effect across sexes.
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Kwon et al. (2026) conducted an RCT in High risk of recurrent ischaemic events after PCI (n=5,506). Clopidogrel monotherapy vs. Aspirin monotherapy was evaluated on composite of all-cause death, myocardial infarction, or stroke (adjusted HR 0.45, 95% CI 0.24-0.85, p=0.014). Clopidogrel monotherapy reduced death, MI, or stroke compared with aspirin in females (4.3% vs 9.4%, HR 0.45) and males (4.4% vs 6.0%, HR 0.77), with no significant sex interaction (P=0.288).
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