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在心房颤动导管消融期间不间断抗凝:更新的随机对照试验荟萃分析显示,直接口服抗凝剂与维生素 K 拮抗剂在大出血和卒中方面无差异。

Uninterrupted anticoagulation during catheter ablation for atrial fibrillation: no difference in major bleeding and stroke between direct oral anticoagulants and vitamin K antagonists in an updated meta-analysis of randomised controlled trials.

机构信息

Medical Faculty, Department of Internal Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University, Düsseldorf, Germany.

CARID - Cardiovascular Research Institute Düsseldorf, Düsseldorf, Germany.

出版信息

Acta Cardiol. 2021 May;76(3):288-295. doi: 10.1080/00015385.2020.1724689. Epub 2020 Feb 14.

DOI:10.1080/00015385.2020.1724689
PMID:32056498
Abstract

BACKGROUND

Periprocedural uninterrupted anticoagulation for catheter ablation of atrial fibrillation (AF) became standard after positive results of vitamin K antagonist (VKA) trials. Previous studies of uninterrupted direct oral anticoagulants (DOACs) vs. VKA have given controversial results. We thus aimed to elucidate the risk/benefit ratio of uninterrupted DOAC vs. VKA during catheter ablation of AF in an updated meta-analysis of randomised controlled trials (RCTs).

METHODS

Online databases were searched for RCTs comparing uninterrupted DOAC to VKA in patients undergoing catheter ablation of AF. Data from retrieved studies were analysed in a comprehensive meta-analysis. Primary safety outcome was major bleeding; primary efficacy outcome was stroke or transient ischaemic attack (TIA). Secondary outcomes included a composite of major bleeding and stroke or TIA, minor bleeding, acute cerebral lesions on magnetic resonance imaging (MRI), and mortality.

RESULTS

Six eligible RCTs comprising 2,369 patients were included. There were no significant differences in DOAC vs. VKA concerning the rates of major bleeding (2.2% vs. 3.8%; odds ratio (OR) 0.69, 95% confidence interval (CI) 0.30-1.56;  = .37) and stroke or TIA (0.2% vs. 0.2%; OR 0.97, CI 0.20-4.72;  = .97). Pooled meta-analysis of secondary outcomes revealed no significant differences (OR 0.73,  = .49 for composite of major bleeding and stroke or TIA; OR 1.08,  = .52 for minor bleeding; OR 1.12,  = .59 for acute cerebral lesions on MRI; and OR 0.60,  = .64 for all-cause mortality).

CONCLUSION

Our meta-analysis suggests that uninterrupted DOAC is not superior to VKA in patients undergoing catheter ablation of AF with comparable rates of major bleeding and stroke.

摘要

背景

在房颤(AF)导管消融中,维生素 K 拮抗剂(VKA)试验的阳性结果后,围手术期不间断抗凝成为标准。之前关于不间断直接口服抗凝剂(DOAC)与 VKA 的研究结果存在争议。因此,我们旨在通过对随机对照试验(RCT)的更新荟萃分析,阐明房颤导管消融中不间断 DOAC 与 VKA 的风险/获益比。

方法

在线数据库中搜索比较 AF 导管消融中不间断 DOAC 与 VKA 的 RCT。从检索到的研究中提取数据进行综合荟萃分析。主要安全性结局是大出血;主要疗效结局是卒中或短暂性脑缺血发作(TIA)。次要结局包括大出血和卒中或 TIA、小出血、磁共振成像(MRI)上的急性脑病变和死亡率的复合结局。

结果

纳入了 6 项包含 2369 例患者的合格 RCT。在 DOAC 与 VKA 比较中,大出血发生率无显著差异(2.2% vs. 3.8%;优势比(OR)0.69,95%置信区间(CI)0.30-1.56; = .37)和卒中或 TIA(0.2% vs. 0.2%;OR 0.97,CI 0.20-4.72; = .97)。次要结局的汇总荟萃分析显示无显著差异(OR 0.73, = .49 用于大出血和卒中或 TIA 的复合结局;OR 1.08, = .52 用于小出血;OR 1.12, = .59 用于 MRI 上的急性脑病变;OR 0.60, = .64 用于全因死亡率)。

结论

我们的荟萃分析表明,在房颤导管消融中,不间断 DOAC 与 VKA 相比,大出血和卒中发生率相似,无优势。

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