Dialysis vascular access thrombosis poses a substantial challenge for individuals undergoing hemodialysis. The efficacy and safety of apixaban, a direct oral coagulation factor Xa inhibitor, in preventing recurrent access thrombosis have yet to be explored. Here, a multicenter randomized control study (NCT04489849) enrolled hemodialysis patients to evaluate this who underwent successful endovascular thrombectomy within 48 hours. Participants were assigned to standard care or standard care plus apixaban, 2.5 mg twice daily for three months. The trial design involved open-label administration, with independent adjudication of endpoints. The primary efficacy endpoint was recurrent access thrombosis within three months after thrombectomy. A total of 186 patients with well-balanced baseline characteristics were enrolled, 93 randomized to the apixaban group and 93 to the control group. The apixaban group demonstrated a significantly lower rate of access thrombosis at three months than the control group (24.0% vs. 40.8%; hazard ratio, 0.52 [95% confidence interval 0.31–0.88]), along with a significantly better primary patency failure rate (32.2% vs. 49.5%, 0.57 [0.36–0.91]). Safety outcomes showed comparable death rates and major bleeding incidents but significantly higher incidence of minor bleeding in the apixaban group (22.6% vs. 7.5%). The effect of apixaban did not show interaction in subgroups of different access types, antiplatelet usage, severity of comorbidities, or history of thrombosis. Thus, apixaban effectively reduced the risk of recurrent thrombosis in hemodialysis vascular access post-thrombectomy. Despite a minor increase in bleeding adverse effects, the net clinical benefit favors the use of apixaban in this context.

中文翻译：

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一项随机对照试验评估了阿哌沙班预防血液透析血管通路血栓切除术后复发性血栓形成的有效性和安全性


透析血管通路血栓形成对接受血液透析的个体构成了重大挑战。阿哌沙班（一种直接口服凝血因子 Xa 抑制剂）在预防复发性通路血栓形成方面的有效性和安全性尚未得到探索。在这里，一项多中心随机对照研究 （NCT04489849） 招募了血液透析患者，以评估在 48 小时内成功接受血管内血栓切除术的患者。参与者被分配到标准护理或标准护理加阿哌沙班，2.5 毫克，每天两次，持续三个月。试验设计涉及开放标签管理，并独立裁决终点。主要疗效终点是血栓切除术后 3 个月内的复发性通路血栓形成。共纳入 186 例基线特征均衡的患者，其中 93 例随机分配到阿哌沙班组，93 例随机分配到对照组。阿哌沙班组在 3 个月时的通路血栓形成率显著低于对照组 （24.0% vs. 40.8%;风险比，0.52 [95% 置信区间 0.31-0.88]），以及显著更高的一期通畅失败率 （32.2% vs. 49.5%，0.57 [0.36-0.91]）。安全性结局显示，阿哌沙班组的死亡率和大出血事件相当，但小出血发生率显著更高 （22.6% vs. 7.5%）。阿哌沙班的效果未显示在不同通路类型、抗血小板使用、合并症严重程度或血栓形成史的亚组中的相互作用。因此，阿哌沙班有效降低了血栓切除术后血液透析血管通路血栓复发的风险。尽管出血不良反应略有增加，但在这种情况下，净临床益处有利于使用阿哌沙班。