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非瓣膜性心房颤动导管消融中直接口服抗凝剂与维生素 K 拮抗剂不间断治疗的比较:随机对照试验的系统评价和荟萃分析。

Uninterrupted direct oral anticoagulants vs. uninterrupted vitamin K antagonists during catheter ablation of non-valvular atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, 2814 Middletown Rd, Bronx, NY, USA.

Division of Cardiovascular Medicine, Vanderbilt University Medical Center, 2220 Pierce Avenue, Nashville, TN, USA.

出版信息

Europace. 2018 Oct 1;20(10):1612-1620. doi: 10.1093/europace/euy133.

Abstract

AIMS

To assess the incremental benefit of uninterrupted direct oral anticoagulants (DOACs) vs. uninterrupted vitamin K antagonists (VKA) for catheter ablation (CA) of non-valvular atrial fibrillation (NVAF) on three primary outcomes: major bleeding, thrombo-embolic events, and minor bleeding. A secondary outcome was post-procedural silent cerebral infarction (SCI) as detected by brain magnetic resonance imaging.

METHODS AND RESULTS

A systematic review of Medline, Cochrane, and Embase was done to find all randomized controlled trials (RCTs) in which uninterrupted DOACs were compared against uninterrupted VKA for CA of NVAF. A fixed-effect model was used, with the exception of the analysis regarding major bleeding events (I2 > 25), for which a random effects model was used. The benefit of uninterrupted DOACs over VKA was analysed from four RCTs that enrolled a total of 1716 patients (male: 71.2%) with NVAF. Of these, 1100 patients (64.1%) had paroxysmal atrial fibrillation. No significant benefit was seen in major bleeding events [risk ratio (RR) 0.54, 95% confidence interval (95% CI) 0.29-1.00; P = 0.05]. No significant differences were found in minor bleeding events (RR 1.11, 95% CI 0.82-1.52; P = 0.50), thrombo-embolic events (RR 0.74, 95% CI 0.26-2.11; P = 0.57), or post-procedural SCI (RR 1.06, 95% CI 0.74-1.53; P = 0.74).

CONCLUSION

An uninterrupted DOACs strategy for CA of NVAF appears to be as safe as uninterrupted VKA without a significantly increased risk of minor or major bleeding events. There was a trend favouring DOACs in terms of major bleeding. Given their ease of use, fewer drug interactions and a similar security and effectiveness profile, DOACs should be considered first line therapy in patients undergoing CA for NVAF.

摘要

目的

评估非瓣膜性心房颤动(NVAF)导管消融(CA)中持续直接口服抗凝剂(DOACs)与持续维生素 K 拮抗剂(VKA)相比,在三个主要结局方面的增量获益:主要出血、血栓栓塞事件和轻微出血。次要结局是通过脑磁共振成像检测到的术后无症状性脑梗死(SCI)。

方法

系统检索 Medline、Cochrane 和 Embase,以查找所有比较 NVAF 中持续 DOACs 与持续 VKA 的随机对照试验(RCT)。除了主要出血事件分析(I2>25%)外,采用固定效应模型,对于主要出血事件分析,采用随机效应模型。四项 RCT 共纳入 1716 例 NVAF 患者(男性:71.2%),分析了持续 DOACs 优于 VKA 的获益。其中,1100 例(64.1%)患者为阵发性心房颤动。主要出血事件无显著获益[风险比(RR)0.54,95%置信区间(95%CI)0.29-1.00;P=0.05]。轻微出血事件(RR 1.11,95%CI 0.82-1.52;P=0.50)、血栓栓塞事件(RR 0.74,95%CI 0.26-2.11;P=0.57)或术后 SCI(RR 1.06,95%CI 0.74-1.53;P=0.74)无显著差异。

结论

对于 NVAF 的 CA,持续 DOACs 策略似乎与持续 VKA 一样安全,且轻微或主要出血事件的风险无显著增加。在主要出血方面,DOACs 有获益趋势。鉴于其使用方便、药物相互作用少以及安全性和有效性相似,DOACs 应被视为 NVAF 行 CA 患者的一线治疗。

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