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非维生素 K 口服抗凝剂与华法林在非瓣膜性心房颤动患者中的比较安全性和有效性:一项网状荟萃分析。

Comparative safety and effectiveness of non-vitamin K oral anticoagulants versus warfarin in patients with non-valvular atrial fibrillation: A network meta-analysis.

机构信息

Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan 33305, Taiwan; College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan; Microscopy Core Laboratory, Chang Gung Memorial Hospital, Linkou, Taoyuan 33305, Taiwan.

Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Chang Gung Memorial Hospital, Linkou Medical Center, Chang Gung University, Taoyuan City, Taiwan.

出版信息

J Formos Med Assoc. 2024 May;123(5):578-586. doi: 10.1016/j.jfma.2023.10.014. Epub 2023 Nov 22.

Abstract

BACKGROUND

The introduction of non-vitamin K antagonist oral anticoagulants (NOACs), with a non-inferior or superior clinical efficacy profile compared to vitamin K antagonists (VKAs), has significantly improved the safety profile and treatment adherence of patients with non-valvular atrial fibrillation (AF). However, few studies have compared the effectiveness and safety of NOACs. Therefore, we conducted this systematic review and network meta-analysis to compare the safety and clinical effectiveness of NOACs and VKAs in patients with non-valvular AF.

METHODS

An online bibliographic search was conducted to retrieve real-world evidence studies published between January 2019 and June 2022.

RESULTS

Dabigatran was associated with lower risks of major bleeding, ischemic stroke, and intracranial hemorrhage than warfarin. Among the NOACs, only dabigatran had a lower risk of all-cause mortality than warfarin. Dabigatran was also associated with lower risks of major bleeding and intracranial hemorrhage than rivaroxaban.

CONCLUSION

Our meta-analysis confirms that dabigatran's real-world safety and clinical effectiveness align with the results of pivotal clinical trials.

摘要

背景

与维生素 K 拮抗剂(VKA)相比,非维生素 K 拮抗剂口服抗凝剂(NOAC)具有非劣效或更优的临床疗效,这显著改善了非瓣膜性心房颤动(AF)患者的安全性和治疗依从性。然而,很少有研究比较过 NOAC 的有效性和安全性。因此,我们进行了这项系统评价和网络荟萃分析,以比较非瓣膜性 AF 患者中 NOAC 和 VKA 的安全性和临床疗效。

方法

在线检索了 2019 年 1 月至 2022 年 6 月期间发表的真实世界证据研究。

结果

与华法林相比,达比加群的大出血、缺血性卒中和颅内出血风险较低。在 NOAC 中,只有达比加群的全因死亡率低于华法林。与利伐沙班相比,达比加群的大出血和颅内出血风险也较低。

结论

我们的荟萃分析证实,达比加群的真实世界安全性和临床疗效与关键性临床试验的结果一致。

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