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Efficacy and Safety of Rivaroxaban Compared with Other Therapies Used in Patients with Peripheral Artery Disease Undergoing Peripheral Revascularization: A Systematic Literature Review and Network Meta-Analysis
Cardiovascular Therapeutics ( IF 3.1 ) Pub Date : 2021-08-24 , DOI: 10.1155/2021/8561350
Rupert Bauersachs 1 , Olivia Wu 2 , Neil Hawkins 2 , Kevin Bowrin 3 , Piotr Wojciechowski 4 , Emilie Clay 5 , Maria Huelsebeck 6
Affiliation  

Background. The guidelines on antithrombotic treatment in patients with symptomatic peripheral artery disease (PAD) undergoing peripheral revascularization of the lower extremities were developed based on heterogeneous trials, assessing various dose regimens and recruiting patients who were subjected to different revascularization procedures. Objective. To compare efficacy and safety of treatments used in patients with PAD undergoing peripheral revascularization accounting for between-trial heterogeneity and large dispersion of the quality of evidence. Methods. A systematic literature review of randomised controlled trials (RCTs) recruiting adult patients with PAD receiving antithrombotics was conducted until January 2020. Hazard ratios (HR) were pooled using Bayesian network meta-analysis. The estimated between-treatment effects were presented as HR together with 95% credible intervals. The base case analysis included studies recruiting patients following recent peripheral revascularization, who received treatment regimens administered within the recommended therapeutic window, while a sensitivity scenario included all identified trials. Results. Thirteen RCTs were identified (8 RCTs enrolled patients following peripheral revascularization and 5 RCTs regardless of the previous revascularization). Five trials, recruiting an overall of 8349 patients, were considered for the base case analysis. Of those, 6564 patients were recruited in the VOYAGER PAD trial comparing rivaroxaban plus aspirin (RIV plus ASA) versus ASA. RIV plus ASA was associated with a lower risk of repeated peripheral revascularization versus ASA monotherapy ( [0.79, 0.99]), however having a trend towards an increased rate of major bleeding ( [0.98, 2.11]). There was no evidence for differences between RIV plus ASA and dual antiplatelet therapy and vitamin K antagonists plus ASA. Similar results were observed in sensitivity analyses. Conclusions. RIV plus ASA is associated with reduced risk of revascularization compared with ASA monotherapy, but the evidence for other comparators, in particular antiplatelet regimens, was insufficient to guide treatment decisions and highlights the challenge in establishing the magnitude of comparative efficacy using existing RCTs.

中文翻译:

利伐沙班与接受外周血运重建的外周动脉疾病患者的其他疗法相比的疗效和安全性:系统文献回顾和网络荟萃分析

背景。有症状的外周动脉疾病 (PAD) 患者接受下肢外周血运重建的抗血栓治疗指南是基于异质性试验、评估各种剂量方案和招募接受不同血运重建手术的患者而制定的。客观。比较在外周血运重建的 PAD 患者中使用的治疗的有效性和安全性,以考虑试验间的异质性和证据质量的大分散。方法. 在 2020 年 1 月之前,对招募 PAD 成年患者接受抗血栓药物的随机对照试验 (RCT) 进行了系统文献回顾。使用贝叶斯网络荟萃分析汇总了风险比 (HR)。估计的治疗间效应以 HR 和 95% 的可信区间表示。基础案例分析包括招募近期接受外周血运重建后患者的研究,这些患者接受了推荐治疗窗口内的治疗方案,而敏感性情景包括所有已确定的试验。结果. 确定了 13 项 RCT(8 项 RCT 招募了外周血运重建后的患者,5 项 RCT 与之前的血运重建无关)。五项试验共招募了 8349 名患者,被考虑用于基础案例分析。其中,VOYAGER PAD 试验招募了 6564 名患者,该试验比较了利伐沙班加阿司匹林(RIV 加 ASA)与 ASA。与 ASA 单药治疗相比,RIV 加 ASA 与重复外周血运重建的风险较低相关([0.79, 0.99]),但是有大出血率增加的趋势([0.98,2.11])。没有证据表明 RIV 加 ASA 与双重抗血小板治疗和维生素 K 拮抗剂加 ASA 之间存在差异。在敏感性分析中也观察到了类似的结果。结论。与 ASA 单药治疗相比,RIV 加 ASA 与血运重建风险降低相关,但其他比较药物的证据,特别是抗血小板方案,不足以指导治疗决策,并强调了使用现有 RCT 确定比较疗效程度的挑战。
更新日期:2021-08-24
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