AIMS Peripheral artery disease (PAD) patients suffer a high risk of major cardiovascular (CV) events, with athero-thrombo-embolism as the underlying pathophysiologic mechanism. Recently, two large randomized clinical trials evaluated the efficacy and safety of low-dose rivaroxaban twice daily plus aspirin in stable PAD outpatients and those immediately after peripheral revascularization. We sought to determine if the effects of low-dose rivaroxaban and aspirin compared to aspirin alone are consistent across this broad spectrum of PAD patients. METHODS AND RESULTS We conducted a random-effects meta-analysis of the COMPASS and VOYAGER randomized trials among 11 560 PAD patients (4996 from COMPASS and 6564 from VOYAGER) in the primary analysis and 9332 (2768 from COMPASS and 6564 from VOYAGER) with lower extremity (LE)-PAD in the secondary analysis. The hazard ratio (HR) for the composite of CV death, myocardial infarction, ischaemic stroke, acute limb ischaemia, or major vascular amputation was 0.79 (95% confidence interval, CI: 0.65-0.95) comparing low-dose rivaroxaban plus aspirin to aspirin alone. While the risk of major bleeding was increased with low-dose rivaroxaban plus aspirin compared to aspirin alone [HR: 1.51 (95% CI: 1.22-1.87)], there was no significant increase in severe bleeding [HR: 1.18 (95% CI: 0.79-1.76)]. Similar effects were observed in the subset with symptomatic LE-PAD. CONCLUSIONS Among PAD patients, low-dose rivaroxaban plus aspirin is superior to aspirin alone in reducing CV and limb outcomes including acute limb ischaemia and major vascular amputation. This reduction is offset by a relative increase in major bleeding, but not by an excess of fatal or critical organ bleeding. The consistency of findings of these trials supports the use of combination low-dose rivaroxaban plus aspirin in PAD patients across a broad spectrum of disease.

中文翻译：

---

外周动脉疾病患者中的低剂量利伐沙班和阿司匹林：COMPASS 和 VOYAGER 试验的荟萃分析。

AIMS 外周动脉疾病 (PAD) 患者发生重大心血管 (CV) 事件的风险很高，动脉粥样硬化血栓栓塞是潜在的病理生理机制。最近，两项大型随机临床试验评估了低剂量利伐沙班每天两次加阿司匹林对稳定的 PAD 门诊患者和外周血运重建后立即进行的患者的疗效和安全性。我们试图确定与单独使用阿司匹林相比，低剂量利伐沙班和阿司匹林的效果在这一广泛的 PAD 患者中是否一致。方次要分析中的肢体（LE）-PAD。将低剂量利伐沙班加阿司匹林与阿司匹林相比，CV 死亡、心肌梗死、缺血性卒中、急性肢体缺血或大血管截肢的复合风险比 (HR) 为 0.79（95% 置信区间，CI：0.65-0.95）独自的。虽然与单用阿司匹林相比，低剂量利伐沙班加阿司匹林的大出血风险增加 [HR：1.51 (95% CI: 1.22-1.87)]，但严重出血的风险没有显着增加 [HR: 1.18 (95% CI) : 0.79-1.76)]。在有症状的 LE-PAD 的子集中观察到类似的效果。结论 在 PAD 患者中，低剂量利伐沙班加阿司匹林在降低 CV 和肢体结局（包括急性肢体缺血和大血管截肢）方面优于单独使用阿司匹林。这种减少被大出血的相对增加所抵消，但不是由于过多的致命或严重器官出血。这些试验结果的一致性支持在广泛疾病范围内的 PAD 患者中使用低剂量利伐沙班联合阿司匹林。