Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow G12 8RZ, UK.
Primary Care Unit, Department of Public Health & Primary Care, University of Cambridge, Cambridge CB2 0SR, UK.
Cardiovasc Ther. 2022 Jun 9;2022:2756682. doi: 10.1155/2022/2756682. eCollection 2022.
Rivaroxaban and apixaban are the most widely used nonvitamin K oral anticoagulants (NOACs) in patients with venous thromboembolism (VTE). This meta-analysis evaluates the effectiveness and safety of both NOACs versus standard of care (SoC) in real-world practice.
Real-world evidence (RWE) studies were identified through a systematic literature review conducted between January 2012 and July 2020, using Embase, MEDLINE, and the websites of cardiological, hematological, and oncological associations. Eligible RWE studies recruited adult patients with deep vein thrombosis and/or pulmonary embolism and presented a comparison between rivaroxaban and apixaban versus SoC, consisting either of vitamin K antagonists, heparins, or combinations thereof. Hazard ratios (HRs) for the comparison between NOACs and SoC were extracted from the relevant studies or estimated based on the reported binary data. The between-treatment contrasts were reported as HRs with associated 95% confidence intervals.
A total of 65 RWE studies were identified and considered relevant for the meta-analysis. Compared with SoC, both rivaroxaban and apixaban were associated with reduced risks of recurrent VTE and a lower rate of major bleeding events. Patients treated with rivaroxaban were at a lower risk of all-cause death compared with those receiving SoC (HR = 0.56 [0.39-0.80]), while evidence for apixaban from the identified studies was insufficient to demonstrate a statistically significant change in mortality (HR = 0.66 [0.30-1.47]).
This analysis indicates that in real-world practice, rivaroxaban and apixaban are associated with a lower risk of recurrent VTE and major bleeding events compared with SoC. Survival benefit in patients treated with rivaroxaban was also observed.
利伐沙班和阿哌沙班是静脉血栓栓塞症（VTE）患者最常用的两种非维生素 K 口服抗凝剂（NOAC）。本荟萃分析评估了这两种 NOAC 与标准治疗（SoC）在真实世界实践中的疗效和安全性。
通过 2012 年 1 月至 2020 年 7 月期间进行的系统文献综述，在 Embase、MEDLINE 和心血管、血液学和肿瘤学协会的网站上确定了真实世界证据（RWE）研究。合格的 RWE 研究招募了患有深静脉血栓形成和/或肺栓塞的成年患者，并比较了利伐沙班和阿哌沙班与 SoC 的疗效，SoC 包括维生素 K 拮抗剂、肝素或两者的组合。从相关研究中提取或根据报告的二项数据估计了比较 NOAC 和 SoC 的风险比（HR）。治疗间比较的结果报告为具有相关 95%置信区间的 HR。
共确定了 65 项 RWE 研究，认为与荟萃分析相关。与 SoC 相比，利伐沙班和阿哌沙班均与降低 VTE 复发风险和降低大出血事件发生率相关。与接受 SoC 的患者相比，接受利伐沙班治疗的患者全因死亡率降低（HR = 0.56 [0.39-0.80]），而从确定的研究中获得的阿哌沙班证据不足以证明死亡率有统计学意义的变化（HR = 0.66 [0.30-1.47]）。
本分析表明，在真实世界实践中，与 SoC 相比，利伐沙班和阿哌沙班与降低 VTE 复发和大出血事件的风险相关。还观察到接受利伐沙班治疗的患者的生存获益。
