Table1_Rivaroxaban plus aspirin vs. dual antiplatelet therapy in endovascular treatment in peripheral artery disease and analysis of medication utilization of different lesioned vascular regions.docx

BackgroundIn the management of Peripheral Arterial Disease (PAD), the administration of anticoagulant or antiplatelet agents is imperative. The use of Dual Antiplatelet Therapy (DAPT) in conjunction with rivaroxaban has shown potential in mitigating adverse outcomes. Given the heterogeneity in the pathology of lower limb arteries, there is a compelling case for individualized treatment strategies.MethodsIn a single-center retrospective study on pharmacotherapy for peripheral artery disease, patients were treated with either aspirin combined with rivaroxaban or aspirin coupled with clopidogrel. The primary efficacy outcome encompassed a composite of increases in the Rutherford classification, acute limb ischemia, amputations due to vascular causes, target lesion revascularization, myocardial infarction, ischemic stroke, and cardiovascular death. The primary safety outcome was major bleeding, as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria; meanwhile, major bleeding as categorized by the International Society on Thrombosis and Haemostasis (ISTH) served as a secondary safety outcome. The study differentiated between two subgroups: patients with only above-the-knee and below-the-knee arterial lesions.ResultsFrom January 2016 to December 2021, 455 patients received either clopidogrel plus aspirin or rivaroxaban plus aspirin following endovascular treatment (EVT). The rivaroxaban group (n = 220) exhibited a lower incidence of primary efficacy outcomes [49.1% vs. 60.4%, hazard ratio (HR) 0.77, P = 0.006] but had more TIMI major bleeding events (5.9% vs. 2.1%, HR 2.6, P = 0.04). ISTH major bleeding events did not show a significant difference, though a higher percentage of rivaroxaban patients discontinued medication due to bleeding (10% vs. 4.7%, HR 2.2, P = 0.03). In the above-the-knee arterial disease subgroup, the rivaroxaban group demonstrated a lower incidence of primary efficacy outcomes (28.2% vs. 45.2%, HR 0.55, P = 0.02). In the below-the-knee arterial disease subgroup, no significant difference was observed in the occurrence of primary efficacy events between the two groups (58.7% vs. 64.8%, HR 0.76, P = 0.14).ConclusionRivaroxaban plus aspirin improved outcomes compared to DAPT in patients with lower extremity artery disease. Similar findings were observed in the above-the-knee artery lesion-only group. However, in the below-the-knee artery lesion-only group, rivaroxaban plus aspirin did not surpass DAPT in efficacy. Regarding safety, rivaroxaban plus aspirin exhibited higher bleeding risks and more frequent treatment discontinuation than aspirin combined with clopidogrel.

背景在外周动脉疾病（PAD）的管理中，抗凝或抗血小板药物的给予是至关重要的。联合使用双抗血小板疗法（DAPT）与利伐沙班在减轻不良预后方面显示出潜力。鉴于下肢动脉病理的异质性，个性化的治疗方案具有强烈的必要性。方法在针对外周动脉疾病药物治疗的单中心回顾性研究中，患者接受阿司匹林联合利伐沙班或阿司匹林联合氯吡格雷的治疗。主要疗效结果包括Rutherford分级提高、急性肢体缺血、血管原因导致的截肢、目标病变血运重建、心肌梗死、缺血性卒中以及心血管死亡等综合指标。主要安全性结果为重大出血，按照心肌梗死溶栓（TIMI）标准定义；同时，根据国际血栓与止血学会（ISTH）的分类，重大出血作为次要安全性结果。研究将患者分为两组：仅存在膝关节以上和以下动脉病变的患者。结果从2016年1月到2021年12月，455名患者在经皮腔内血管成形术（EVT）治疗后接受了氯吡格雷加阿司匹林或利伐沙班加阿司匹林的治疗。利伐沙班组（n=220）的主要疗效结果发生率较低[49.1% vs. 60.4%，风险比（HR）0.77，P=0.006]，但TIMI重大出血事件较多（5.9% vs. 2.1%，HR 2.6，P=0.04）。ISTH重大出血事件没有显著差异，尽管利伐沙班患者的停药比例较高（10% vs. 4.7%，HR 2.2，P=0.03）。在膝关节以上动脉疾病亚组中，利伐沙班组的主要疗效结果发生率较低（28.2% vs. 45.2%，HR 0.55，P=0.02）。在膝关节以下动脉疾病亚组中，两组之间主要疗效事件的发生率没有显著差异（58.7% vs. 64.8%，HR 0.76，P=0.14）。结论与DAPT相比，利伐沙班加阿司匹林在治疗下肢动脉疾病患者中改善了预后。在仅存在膝关节以上动脉病变的亚组中，也观察到了相似的结果。然而，在仅存在膝关节以下动脉病变的亚组中，利伐沙班加阿司匹林在疗效上并未超越DAPT。在安全性方面，利伐沙班加阿司匹林表现出更高的出血风险和更频繁的治疗中断，相较于阿司匹林联合氯吡格雷。