Efficacy and safety of Apixaban for the prevention of thrombosis in arteriovenous grafts.

IF 1.8 Q3 MEDICINE, RESEARCH & EXPERIMENTAL European Journal of Translational Myology Pub Date : 2024-01-15 DOI:10.4081/ejtm.2024.12029
Arash Hedayat, Aidin Esrafilian Soltani, Mahdi Hakiminezhad, Fateme Zareian, Mandana Saneian, Mohamad Moradmand, Sahand Abrishami, Mohamad Hosein Tabatabaei Nodoushan, Ali Pouriayevali, Mahdi Mohebbi, Helia Ghorbani
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Abstract

This research aims to fill a vital gap in existing studies by evaluating the efficacy and safety of Apixaban, a direct oral anticoagulant, in the prevention of arteriovenous graft (AVG) thrombosis, thereby offering substantial insights into alternative anticoagulant options for hemodialysis patients. Conducted as a multi-center, randomized, double-blind, placebo-controlled trial, this study involved end-stage renal disease (ESRD) patients who had recently received polytetrafluoroethylene grafts. Participants were assigned to receive either Apixaban at a dose of 2.5 mg twice daily or a placebo. The primary outcome measure was the occurrence of graft thrombosis, while secondary outcomes focused on the incidence and severity of bleeding. Analytical methods included Kaplan-Meier estimates, Cox proportional hazards models, and conventional statistical tests. With 96 patients enrolled, the study found that Apixaban significantly reduced the incidence of AVG thrombosis compared to placebo (16.7% vs. 62.5%, P < 0.0001). Notably, this reduction in thrombosis incidence was not accompanied by an increase in bleeding events, thus affirming the safety profile of Apixaban as established in prior research. Apixaban is identified as an efficacious alternative to traditional anticoagulants in the prevention of AVG thrombosis among hemodialysis patients, representing a notable advancement in the care of individuals with ESRD. The results of this study support further investigations into the optimal dosing strategies specifically tailored for this patient demographic.

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阿哌沙班预防动静脉移植物血栓形成的有效性和安全性。
这项研究旨在通过评估阿哌沙班(一种直接口服抗凝剂)在预防动静脉移植物(AVG)血栓形成方面的有效性和安全性,填补现有研究的一个重要空白,从而为血液透析患者选择其他抗凝剂提供重要启示。该研究以多中心、随机、双盲、安慰剂对照试验的形式进行,参与者包括最近接受过聚四氟乙烯移植物治疗的终末期肾病(ESRD)患者。参与者被分配接受阿哌沙班治疗,剂量为 2.5 毫克,每天两次或安慰剂。主要结果指标是移植物血栓形成的发生率,次要结果指标是出血的发生率和严重程度。分析方法包括卡普兰-梅耶估计、Cox比例危险模型和常规统计检验。研究发现,与安慰剂相比,阿哌沙班能显著降低 AVG 血栓形成的发生率(16.7% 对 62.5%,P < 0.0001)。值得注意的是,血栓形成发生率的降低并没有伴随出血事件的增加,从而肯定了阿哌沙班在先前研究中确立的安全性。阿哌沙班被认为是预防血液透析患者动静脉瘘血栓形成的传统抗凝剂的有效替代品,代表着 ESRD 患者护理的显著进步。这项研究的结果支持进一步研究专门针对这一患者群体的最佳剂量策略。
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来源期刊
European Journal of Translational Myology
European Journal of Translational Myology MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.30
自引率
27.30%
发文量
74
审稿时长
10 weeks
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