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一项随机对照试验评估了阿哌沙班在预防血液透析血管通路血栓切除术后复发性血栓形成方面的疗效和安全性。

A randomized controlled trial evaluated the efficacy and safety of apixaban for prevention of recurrent thrombosis after thrombectomy of hemodialysis vascular access.

作者信息

Ko Tsung-Yu, Wu Chih-Cheng, Hsieh Mu-Yang, Yang Chung-Wei, Cheng Chi-Hung, Chen Chun-Kai, Kao Hsien-Li

机构信息

Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University, Taipei, Taiwan.

Cardiovascular Center, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan; Center of Quality Management, National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan; Institute of Biomedical Engineering, National Tsing-Hua University, Hsinchu, Taiwan; Institute of Cellular and System Medicine, National Health Research Institutes, Zhunan, Taiwan.

出版信息

Kidney Int. 2025 Feb;107(2):348-358. doi: 10.1016/j.kint.2024.10.023. Epub 2024 Nov 16.

Abstract

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.

摘要

透析血管通路血栓形成对接受血液透析的患者构成了重大挑战。阿哌沙班是一种直接口服的凝血因子Xa抑制剂,其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。在此,一项多中心随机对照研究(NCT04489849)纳入了血液透析患者,以评估在48小时内成功进行血管内血栓切除术的患者。参与者被分配接受标准护理或标准护理加阿哌沙班治疗,阿哌沙班剂量为每日两次,每次2.5毫克,共三个月。试验设计采用开放标签给药,并对终点进行独立判定。主要疗效终点是血栓切除术后三个月内复发性通路血栓形成。总共纳入了186例基线特征均衡的患者,93例随机分配至阿哌沙班组,93例分配至对照组。阿哌沙班组在三个月时的通路血栓形成率显著低于对照组(24.0%对40.8%;风险比,0.52 [95%置信区间0.31 - 0.88]),主要通畅失败率也显著更低(32.2%对49.5%,0.57 [0.36 - 0.91])。安全性结果显示死亡率和大出血事件相当,但阿哌沙班组的小出血发生率显著更高(22.6%对7.5%)。阿哌沙班的效果在不同通路类型、抗血小板药物使用、合并症严重程度或血栓形成病史的亚组中未显示出相互作用。因此,阿哌沙班有效降低了血液透析血管通路血栓切除术后复发性血栓形成的风险。尽管出血不良反应略有增加,但在此情况下,阿哌沙班的净临床获益支持其使用。

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