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：在周围动脉疾病（PAD）的管理中，抗凝或抗血小板药物的应用至关重要。联合使用双抗血小板治疗（DAPT）与利伐沙班在减轻不良预后方面显示出潜在效用。鉴于下肢动脉病理的异质性，个性化治疗策略具有强烈的需求。方法：在一项针对周围动脉疾病药物治疗的单中心回顾性研究中，患者接受了阿司匹林与利伐沙班或阿司匹林与氯吡格雷的联合治疗。主要疗效结果包括Rutherford分类的改善、急性肢体缺血、因血管原因导致的截肢、靶病变血运重建、心肌梗死、缺血性卒中以及心血管死亡的综合指标。主要安全性结果为根据心肌梗死溶栓（TIMI）标准定义的大出血；同时，根据国际血栓与止血学会（ISTH）的分类，大出血作为次要安全性结果。研究将患者分为两组：仅存在膝上和膝下动脉病变的患者。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与阿司匹林或利伐沙班与阿司匹林的联合治疗。利伐沙班组（n=220）的主要疗效结果发生率较低[49.1%比60.4%，风险比（HR）0.77，P=0.006]，但TIMI大出血事件较多（5.9%比2.1%，HR 2.6，P=0.04）。ISTH大出血事件未显示出显著差异，尽管利伐沙班患者因出血而停药的比例较高（10%比4.7%，HR 2.2，P=0.03）。在膝上动脉疾病亚组中，利伐沙班组的主要疗效结果发生率较低（28.2%比45.2%，HR 0.55，P=0.02）。在膝下动脉疾病亚组中，两组间主要疗效事件的发生率无显著差异（58.7%比64.8%，HR 0.76，P=0.14）。结论：与DAPT相比，利伐沙班与阿司匹林的联合应用在下肢动脉疾病患者中改善了预后。在仅存在膝上动脉病变的亚组中观察到相似的结果。然而，在仅存在膝下动脉病变的亚组中，利伐沙班与阿司匹林的联合应用在疗效上并未超越DAPT。就安全性而言，利伐沙班与阿司匹林的联合应用比阿司匹林与氯吡格雷的联合应用显示出更高的出血风险和更频繁的治疗中断。