女性与男性经皮冠状动脉介入治疗后氯吡格雷单药治疗对比阿司匹林单药治疗：SMART-CHOICE 3试验的性别分层分析。
完整摘要 · 中文译文
背景：氯吡格雷已成为经皮冠状动脉介入治疗（PCI）后维持治疗中阿司匹林单药治疗的一种有前景的替代方案；然而，根据性别选择最佳抗血小板策略仍存在争议。 目的：我们旨在探讨抗血小板治疗的效果是否因性别而异。 方法：本研究是SMART-CHOICE 3试验的一项预设亚组研究。在PCI后已完成标准双联抗血小板治疗疗程的复发性缺血事件高风险患者被随机分配接受氯吡格雷或阿司匹林单药治疗。主要终点是全因死亡、心肌梗死或卒中的复合终点。 结果：在韩国共纳入5,506例患者，其中女性1,002例，男性4,504例。女性的风险特征高于男性；然而，主要终点的发生率在女性和男性之间无显著差异（6.7% vs 5.2%，校正风险比[HR] 0.89，95%置信区间[CI]：0.62-1.28；p=0.537）。与阿司匹林相比，氯吡格雷显著降低了女性的主要终点发生率（4.3% vs 9.4%，校正HR 0.45，95% CI：0.24-0.85；p=0.014），但在男性中未显著降低（4.4% vs 6.0%，校正HR 0.77，95% CI：0.56-1.07；p=0.116）。性别与抗血小板治疗之间无显著交互作用（交互作用p=0.288）。 结论：在PCI术后远期且复发性缺血事件高风险的患者中，氯吡格雷单药治疗在降低全因死亡、心肌梗死或卒中的复合终点方面显示出方向一致的减少。 与阿司匹林相比，在女性和男性中均能降低死亡、心肌梗死或卒中风险。未观察到显著的性别-治疗交互作用，支持治疗效果在性别间具有一致性。
完整摘要 · 英文原文
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.