Department of Pharmacy, Peking University First Hospital, No. 6, Dahongluochang Street, Xicheng District, Beijing, 100034, China.
School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing, China.
BMC Cardiovasc Disord. 2022 Mar 14;22(1):105. doi: 10.1186/s12872-022-02550-8.
The real-world studies on recurrent venous thromboembolism (VTE) and bleeding events of non-vitamin K antagonist oral anticoagulants (NOACs) in VTE patients have reported conflicting findings. Our study aimed to provide the direct comparison evidence of different NOACs for VTE patients in clinical practice settings.
Search of the medical literature was conducted using PubMed, Web of Science, EMBASE, Clinical Trials.gov, and the Cochrane Library from inception to March 22, 2021. Among the 19,996 citations retrieved, a total of 63,144 patients from 6 studies were analyzed. Clinical outcomes included recurrent VTE, death, and different bleeding events.
Adjusted hazard ratio (HR) analysis suggested that apixaban had significant lower bleeding riskthan rivaroxaban (major, minor and any bleeding: HR = 0.61, 0.56, 0.70; p = 0.008, < 0.0001, 0.006, respectively), but no statistics difference found in recurrent VTE events (HR = 1.02, 95% confidence interval (CI) 0.71-1.47, p = 0.93). There was no significant difference of major bleeding between dabigatran and rivaroxaban (odds ratios (OR) = 0.41, 95% CI 0.09-1.90, p = 0.25), apixaban and dabigatran (OR 0.64, 95% CI 0.15-2.72, p = 0.83). No significant difference was found in the comparison of edoxaban and other NOACs in VTE recurrence, major bleeding and composite outcome.
In the prevention of bleeding events, apixaban was associated with a lower risk than rivaroxaban, but equivalent efficacy for different NOACs in prevention of recurrent VTE. Evidence generated from the meta-analysis based on real-world data can help to guide selection between apixaban and rivaroxaban in routine clinical practice.
This systematic review and meta-analysis were conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis and Meta-analysis of Observational Studies in Epidemiology statements and was registered with PROSPERO (CRD42019140553).
非维生素 K 拮抗剂口服抗凝剂（NOACs）在静脉血栓栓塞症（VTE）患者中的真实世界研究中，关于复发性静脉血栓栓塞（VTE）和出血事件的结果存在相互矛盾。我们的研究旨在为临床实践中 VTE 患者提供不同 NOACs 的直接比较证据。
从建库至 2021 年 3 月 22 日，通过 PubMed、Web of Science、EMBASE、ClinicalTrials.gov 和 Cochrane Library 对医学文献进行检索。在检索到的 19996 篇文献中，对来自 6 项研究的 63144 例患者进行了分析。临床结局包括复发性 VTE、死亡和不同的出血事件。
调整后的风险比（HR）分析表明，与利伐沙班相比，阿哌沙班出血风险显著降低（大出血、小出血和任何出血：HR=0.61、0.56 和 0.70；p=0.008、<0.0001 和 0.006），但在 VTE 复发事件中无统计学差异（HR=1.02，95%置信区间 0.71-1.47，p=0.93）。达比加群与利伐沙班大出血的风险无显著差异（比值比（OR）=0.41，95%置信区间 0.09-1.90，p=0.25），阿哌沙班与达比加群大出血的风险无显著差异（OR=0.64，95%置信区间 0.15-2.72，p=0.83）。在比较依度沙班与其他 NOACs 时，VTE 复发、大出血和复合结局均无显著差异。
在预防出血事件方面，阿哌沙班与利伐沙班相比，出血风险较低，但在预防 VTE 复发方面，不同的 NOACs 疗效相当。基于真实世界数据的荟萃分析结果可为常规临床实践中阿哌沙班和利伐沙班的选择提供依据。
本系统评价和荟萃分析根据系统评价和荟萃分析的首选报告项目和观察性研究荟萃分析的流行病学声明进行，并在 PROSPERO（CRD42019140553）中进行了注册。
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