Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, No. 167, Beilishi Road, Xicheng District, Beijing 100037, China.
Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.
Cardiovasc Res. 2021 Feb 22;117(3):942-949. doi: 10.1093/cvr/cvaa100.
The COMPASS trial demonstrated that the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced major adverse cardiovascular events (MACE) in patients with chronic coronary artery disease or peripheral artery disease by 24% during a mean follow-up of 23 months. We explored whether this effect varies by sex.
The effects were examined in women and men using log-rank tests and Kaplan-Meier curve. Hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were obtained from stratified Cox proportional hazards models to explore subgroup effects including subgroup of women and men according to baseline modified REACH risk score. Of 27 395 patients randomized, 18 278 were allocated to receive rivaroxaban plus aspirin (n = 9152) or aspirin alone (n = 9126), and of these, 22.1% were women. Women compared with men had similar incidence rates for MACE and major bleeding but borderline lower rates for myocardial infarction (1.7% vs. 2.2%, P = 0.05). The effect of combination therapy compared with aspirin in women and men was consistent for MACE (women: 3.8% vs. 5.2%, HR 0.72, 95% CI 0.54-0.97; men: 4.2% vs. 5.5%, HR 0.76, 95% CI 0.66-0.89; P interaction 0.75) and major bleeding (women: 3.1% vs. 1.4%, HR 2.22, 95% CI 1.42-3.46; men: 3.2% vs. 2.0%, HR 1.60, 95% CI 1.29-1.97; P interaction 0.19). There was no significant interaction between randomized treatment and baseline modified REACH score above or below the median for MACE or major bleeding.
In patients with stable coronary artery disease or peripheral artery disease, the combination of rivaroxaban (2.5 mg twice daily) and aspirin compared with aspirin alone appears to produce consistent benefits in women and men, independent of baseline cardiovascular risk.
COMPASS 试验表明，与每日一次口服 100mg 阿司匹林相比，每日两次口服 2.5mg 利伐沙班联合每日一次口服 100mg 阿司匹林可使慢性冠状动脉疾病或外周动脉疾病患者的主要不良心血管事件（MACE）减少 24%，中位随访时间为 23 个月。我们探讨了这种效果是否因性别而异。
使用对数秩检验和 Kaplan-Meier 曲线在女性和男性中检查了这些效果。分层 Cox 比例风险模型获得了危险比（HR）和相应的 95%置信区间（CI），以探讨包括根据基线改良 REACH 风险评分的女性和男性亚组在内的亚组效应。在 27395 名随机患者中，18278 名被分配接受利伐沙班加阿司匹林（n=9152）或单独阿司匹林（n=9126）治疗，其中 22.1%为女性。与男性相比，女性 MACE 和大出血的发生率相似，但心肌梗死的发生率较低（1.7% vs. 2.2%，P=0.05）。与阿司匹林相比，联合治疗在女性和男性中的效果一致，用于 MACE（女性：3.8% vs. 5.2%，HR 0.72，95%CI 0.54-0.97；男性：4.2% vs. 5.5%，HR 0.76，95%CI 0.66-0.89；P 交互作用 0.75）和大出血（女性：3.1% vs. 1.4%，HR 2.22，95%CI 1.42-3.46；男性：3.2% vs. 2.0%，HR 1.60，95%CI 1.29-1.97；P 交互作用 0.19）。在 MACE 或大出血方面，随机治疗与中位数以上或以下的基线改良 REACH 评分之间没有显著的交互作用。
在稳定型冠状动脉疾病或外周动脉疾病患者中，与单独使用阿司匹林相比，每日两次口服 2.5mg 利伐沙班联合每日一次口服 100mg 阿司匹林似乎对女性和男性均有一致的获益，且与基线心血管风险无关。
