Aims It is unknown whether Asian and non-Asian patients with atherosclerotic vascular disease derive similar benefits from long-term antithrombotic therapy. Methods and results In patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in The Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, the effects of rivaroxaban 2.5 mg b.i.d. plus aspirin 100 mg o.d. were compared with those of aspirin 100 mg o.d. in Asian vs. non-Asian patients (race was self-identified). Asians (n = 4269) vs. non-Asians (n = 23 126) had similar rates of major adverse cardiovascular events (MACEs) (4.85% vs. 4.83%, P = 0.30) and modified International Society on Thrombosis and Haemostasis (ISTH) major bleeding (2.72% vs. 2.58%, P = 0.22), but higher rates of intracranial haemorrhage (ICH) (0.63% vs. 0.29%, P = 0.01) and minor bleeding (13.61% vs. 6.49%, P < 0.001). In Asians vs. non-Asians, the combination of rivaroxaban and aspirin compared with aspirin alone produced consistent reductions in MACE [Asians: hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.45–0.90; non-Asians: HR: 0.78, 95% CI: 0.67–0.90; P(heterogeneity) = 0.29], increases in modified ISTH major bleeding (Asians: HR 2.24, 95% CI: 1.40–3.58; non-Asians: HR: 1.60, 95% CI: 1.30–1.97; P = 0.20), and net clinical outcome (Asians: HR: 0.77, 95% CI: 0.56–1.05; non-Asians: HR: 0.81, 95% CI: 0.70–0.93, P = 0.78), but borderline higher rates of ICH (Asians: HR: 3.50, 95% CI: 0.98–12.56; non-Asians: HR: 0.81, 95% CI: 0.43, 1.53; P = 0.04). Conclusion Asian compared with non-Asian patients with chronic CAD and/or PAD have higher rates of ICH and minor bleeding. The combination of rivaroxaban and aspirin vs. aspirin alone produces similar effects for MACE, modified ISTH major bleeding, and net clinical outcome but may be associated with higher rates of ICH in Asian patients.

中文翻译：

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亚洲慢性冠状动脉疾病或外周动脉疾病非亚洲患者与利伐沙班和阿司匹林与单独阿司匹林的比较：COMPASS 试验

目的 目前尚不清楚亚洲和非亚洲的动脉粥样硬化性血管疾病患者是否从长期抗血栓治疗中获得相似的益处。方法和结果 在参加“使用抗凝策略的人的心血管结局”试验的慢性冠状动脉疾病 (CAD) 和/或外周动脉疾病 (PAD) 患者中，将利伐沙班 2.5 mg bid 加阿司匹林 100 mg od 的效果与那些亚洲与非亚洲患者的阿司匹林 100 mg od（种族是自我识别的）。亚洲人 (n = 4269) 与非亚洲人 (n = 23 126) 的主要不良心血管事件 (MACE) 发生率相似 (4.85% vs. 4.83%, P = 0.30) 和改良的国际血栓和止血学会 (ISTH) ) 大出血 (2.72% vs. 2.58%, P = 0.22)，但颅内出血 (ICH) 发生率较高 (0.63% vs. 0.29%, P = 0.01) 和轻微出血 (13.61% vs. 6.49%, P < 0.001)。在亚洲人与非亚洲人中，利伐沙班联合阿司匹林与单独阿司匹林相比，MACE 持续降低 [亚洲人：风险比 (HR)：0.64，95% 置信区间 (CI)：0.45–0.90；非亚洲人：HR：0.78，95% CI：0.67–0.90；P（异质性）= 0.29]，改良 ISTH 大出血增加（亚洲人：HR 2.24，95% CI：1.40–3.58；非亚洲人：HR：1.60，95% CI：1.30–1.97；P = 0.20），以及净临床结果（亚洲人：HR：0.77，95% CI：0.56-1.05；非亚洲人：HR：0.81，95% CI：0.70-0.93，P = 0.78），但 ICH 发生率较高（亚洲人：HR： 3.50，95% CI：0.98–12.56；非亚洲人：HR：0.81，95% CI：0.43，1.53；P = 0.04）。结论 与非亚洲人相比，亚洲慢性 CAD 和/或 PAD 患者的 ICH 和轻微出血发生率更高。