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与维生素 K 拮抗剂相比,直接口服抗凝药持续和最小中断给药用于房颤消融均安全:一项更新的荟萃分析。

Continuous and minimally-interrupted direct oral anticoagulant are both safe compared with vitamin K antagonist for atrial fibrillation ablation: An updated meta-analysis.

机构信息

Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom; Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.

Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom.

出版信息

Int J Cardiol. 2018 Jul 1;262:51-56. doi: 10.1016/j.ijcard.2018.03.095. Epub 2018 Mar 21.

DOI:10.1016/j.ijcard.2018.03.095
PMID:29606512
Abstract

BACKGROUND

The appropriate and safe peri-procedural anticoagulation schedule for patients on a direct oral anticoagulant (DOAC) undergoing AF ablation is not known. We aimed to evaluate the safety and efficacy of both continuous and minimally-interrupted novel oral anticoagulant (DOAC) strategies compared with uninterrupted vitamin K antagonist (VKA) for atrial fibrillation (AF) ablation.

METHODS

We searched electronic databases for randomized or prospective controlled observational studies comparing DOAC (continuous or interrupted) versus uninterrupted VKA. The primary endpoint was major bleeding. Secondary endpoints were total bleeding (composite of major and minor bleeding) and symptomatic thromboembolism. Data were analyzed by random-effects modeling and sensitivity analyses performed according to study design and peri-procedural DOAC schedule.

RESULTS

Thirteen studies (4 randomized, 9 observational) with 5463 patients were included in final analysis (45% on DOAC). DOAC was associated with less major bleeding compared with VKA in pooled randomized studies (odds ratio [OR] 0.27, 95% confidence interval [CI] 0.09-0.80, p = 0.03, I = 0%), however there was no difference on overall analyses (OR 0.70, 95% CI 0.39-1.24, p = 0.22, I = 27%). When stratified by DOAC dose schedule, there was no difference in major bleeding for continuous DOAC (OR 0.48, 95% CI 0.21-1.11, p = 0.09, I = 6%) or minimally-interrupted DOAC (OR 0.81, 95% CI 0.37-1.76, p = 0.60, I = 43%) compared with VKA. There was no difference between DOAC and VKA for risk of total bleeding (p = 0.20) or symptomatic thromboembolism (p = 0.78).

CONCLUSION

Continuous and minimally-interrupted DOAC are both safe and non-inferior peri-procedural anticoagulation strategies compared with uninterrupted VKA for AF ablation. DOAC in general is associated with reduced major bleeding as demonstrated in pooled randomized studies.

摘要

背景

对于正在服用直接口服抗凝剂(DOAC)的患者,在接受房颤消融术时,合适且安全的围手术期抗凝方案尚不清楚。我们旨在评估连续和最小中断新型口服抗凝剂(DOAC)策略与不间断维生素 K 拮抗剂(VKA)相比,在房颤消融术中的安全性和有效性。

方法

我们在电子数据库中搜索了比较 DOAC(连续或中断)与不间断 VKA 的随机或前瞻性对照观察性研究。主要终点是大出血。次要终点是总出血(包括主要和次要出血)和有症状的血栓栓塞。数据采用随机效应模型进行分析,并根据研究设计和围手术期 DOAC 方案进行敏感性分析。

结果

最终分析纳入了 13 项研究(4 项随机,9 项观察性)共 5463 例患者(45%的患者服用 DOAC)。与 VKA 相比,DOAC 在汇总的随机研究中与较少的大出血相关(比值比 [OR] 0.27,95%置信区间 [CI] 0.09-0.80,p=0.03,I=0%),但总体分析中无差异(OR 0.70,95%CI 0.39-1.24,p=0.22,I=27%)。按 DOAC 剂量方案分层,连续 DOAC(OR 0.48,95%CI 0.21-1.11,p=0.09,I=6%)或最小中断 DOAC(OR 0.81,95%CI 0.37-1.76,p=0.60,I=43%)与 VKA 相比,大出血风险无差异。与 VKA 相比,DOAC 与总出血风险(p=0.20)或有症状的血栓栓塞风险(p=0.78)无差异。

结论

与不间断 VKA 相比,连续和最小中断 DOAC 都是安全且非劣效的房颤消融术围手术期抗凝策略。与汇总的随机研究一致,一般情况下,DOAC 与减少大出血相关。

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