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欧洲比较口服抗凝剂用于非瓣膜性房颤的真实世界证据:一项系统评价和网状Meta分析。

Real-world evidence comparing oral anticoagulants for NVAF in Europe: a systematic review and network meta-analysis.

作者信息

Cichewicz Allie, Jawla Shantanu, Zuchinali Priccila, Akin-Fajiye Morodoluwa, Massierer Daniela, Porto Italo, Garcia-Moll Xavier

机构信息

Evidence Synthesis, Evidera, Wilmington, NC, USA.

European Specialty Value and Access, Daiichi Sankyo Europe GmbH, Munich, Germany.

出版信息

Future Cardiol. 2025 May;21(6):371-390. doi: 10.1080/14796678.2025.2484119. Epub 2025 Apr 2.

Abstract

AIM

Atrial fibrillation is the most commonly sustained cardiac arrhythmia, increasing the risk of stroke and systemic embolic events. This systematic review and network meta-analysis (NMA) aimed to compare real-world evidence (RWE) on the effectiveness and safety of edoxaban with other direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) in Europe.

MATERIALS & METHODS: Searches from January 2013 to December 2022 identified comparative observational studies assessing effectiveness/safety outcomes in patients with NVAF. Bayesian NMA estimated comparative effectiveness/safety of edoxaban with other DOACs and VKAs.

RESULTS

The review identified 57 studies analyzing data from 24 unique databases; 33 studies were included in the base-case analyses. DOACs showed benefit over VKAs for most outcomes, of which major bleeding and all-cause mortality were most commonly reported. Edoxaban demonstrated a comparable effectiveness/safety profile to other DOACs and significantly reduced risk of major bleeding (hazard ratio [95% credible interval]: 0.67 [0.54, 0.84]) and intracranial hemorrhage (0.69 [0.51, 0.94]) versus rivaroxaban.

CONCLUSION

This NMA provides valuable insights into the real-world effectiveness and safety of DOACs and VKAs in Europe, supporting clinical decision-making and adding to the existing evidence base from clinical trials.

摘要

目的

心房颤动是最常见的持续性心律失常,会增加中风和全身性栓塞事件的风险。本系统评价和网络荟萃分析(NMA)旨在比较在欧洲非瓣膜性心房颤动(NVAF)患者中,依度沙班与其他直接口服抗凝剂(DOACs)和维生素K拮抗剂(VKAs)在有效性和安全性方面的真实世界证据(RWE)。

材料与方法

检索2013年1月至2022年12月期间评估NVAF患者有效性/安全性结局的比较观察性研究。贝叶斯NMA估计了依度沙班与其他DOACs和VKAs的比较有效性/安全性。

结果

该评价共识别出57项分析来自24个独立数据库数据的研究;33项研究纳入了基础病例分析。在大多数结局方面,DOACs显示出优于VKAs的效果,其中最常报告的是大出血和全因死亡率。与利伐沙班相比,依度沙班显示出与其他DOACs相当的有效性/安全性概况,并显著降低了大出血风险(风险比[95%可信区间]:0.67[0.54,0.84])和颅内出血风险(0.69[0.51,0.94])。

结论

本NMA为欧洲DOACs和VKAs的真实世界有效性和安全性提供了有价值的见解,支持临床决策,并为现有临床试验证据库增添了内容。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6afe/12026226/d3dd65043d82/IFCA_A_2484119_F0001_B.jpg

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