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非维生素 K 拮抗剂口服抗凝剂在心房颤动导管消融中的安全性和有效性:系统评价和荟萃分析。

Safety and efficacy of nonvitamin K antagonist oral anticoagulants during catheter ablation of atrial fibrillation: A systematic review and meta-analysis.

机构信息

Icahn School of Medicine at Mount Sinai, Zena and Michael A. Wiener Cardiovascular Institute, New York, New York.

Division of cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.

出版信息

Cardiovasc Ther. 2018 Oct;36(5):e12457. doi: 10.1111/1755-5922.12457. Epub 2018 Jul 30.

DOI:10.1111/1755-5922.12457
PMID:29971964
Abstract

AIMS

Catheter ablation for atrial fibrillation (AF) is associated with a transitory increase in the risk of both thromboembolic and bleeding events. Evidence on the use of nonvitamin K antagonist oral anticoagulants (NOACs) in patients undergoing AF ablation mostly comes from small observational studies, underpowered to detect differences in clinical outcomes between NOACs and vitamin K antagonists (VKAs) treated patients. This updated meta-analysis aimed to determine the safety and efficacy of periprocedural anticoagulation with NOACs compared with VKAs in AF patients undergoing catheter ablation.

METHODS

We searched MEDLINE, Cochrane library, and web sources for randomized and observational studies comparing periprocedural treatment with NOACs and VKAs in patients undergoing AF ablation. The primary safety endpoint was major bleeding events, and the primary efficacy endpoint was thromboembolic events (a composite of systemic thromboembolism, transient ischemic attack, and stroke).

RESULTS

A total of 29 studies with 12 644 patients were included in the meta-analysis. Overall, patients on NOACs had a significantly lower risk of major bleeding compared to VKAs either in observational studies (Peto OR 0.68; 95% CI: 0.48-0.95; P = 0.022; I  = 20%) or in RCTs (Peto OR 0.30; 95% CI: 0.14-0.62; P = 0.001; I  = 28%). Uninterrupted NOACs reduced the risk of major bleeding when compared to uninterrupted VKAs (Peto OR 0.66; 95% CI: 0.45-0.96; P = 0.028; I  = 1%), similarly, interrupted NOACs lowered the risk of major bleeding compared to interrupted VKAs (Peto OR 0.29; 95% CI: 0.13-0.66; P = 0.003; I  = 0%; P  = 0.076). The rate of thromboembolic complications was very low and did not significantly differ between the study groups either in observational studies (Peto OR 0.91; 95% CI: 0.49-1.67; P = 0.755; I  = 0%) or in RCTs (Peto OR 0.14; 95% CI: 0.01-1.30; P = 0.083; I  = 0%).

CONCLUSIONS

Use of NOACs compared to VKAs significantly reduced the risk of bleeding in patients with AF ablation. Similarly, the risk of bleeding was lower with uninterrupted NOACs than with uninterrupted VKAs, and with interrupted NOACs than with interrupted VKAs. The rate of thromboembolic complications was extremely low in both study groups without any differences.

摘要

目的

房颤(AF)的导管消融与血栓栓塞和出血事件风险的短暂增加相关。关于非维生素 K 拮抗剂口服抗凝剂(NOACs)在接受 AF 消融治疗的患者中的应用证据主要来自小型观察性研究,这些研究的效力不足以检测出 NOACs 和维生素 K 拮抗剂(VKA)治疗患者之间的临床结局差异。本更新的荟萃分析旨在确定在接受 AF 导管消融的患者中,与 VKA 相比,围手术期使用 NOACs 的安全性和疗效。

方法

我们在 MEDLINE、Cochrane 图书馆和网络资源中搜索了比较接受 AF 消融治疗的患者围手术期使用 NOACs 和 VKA 的随机和观察性研究。主要安全性终点是大出血事件,主要疗效终点是血栓栓塞事件(全身性血栓栓塞、短暂性脑缺血发作和中风的复合事件)。

结果

共有 29 项研究,纳入了 12644 名患者,纳入了荟萃分析。总体而言,与 VKA 相比,NOACs 无论是在观察性研究(Peto OR 0.68;95%CI:0.48-0.95;P=0.022;I²=20%)还是随机对照试验(Peto OR 0.30;95%CI:0.14-0.62;P=0.001;I²=28%)中,使用 NOACs 的患者大出血风险显著降低。与不间断 VKA 相比,不间断使用 NOACs 可降低大出血风险(Peto OR 0.66;95%CI:0.45-0.96;P=0.028;I²=1%),同样,与不间断 VKA 相比,间断使用 NOACs 可降低大出血风险(Peto OR 0.29;95%CI:0.13-0.66;P=0.003;I²=0%;P=0.076)。血栓栓塞并发症的发生率非常低,且在观察性研究(Peto OR 0.91;95%CI:0.49-1.67;P=0.755;I²=0%)或随机对照试验(Peto OR 0.14;95%CI:0.01-1.30;P=0.083;I²=0%)中两组之间均无显著差异。

结论

与 VKA 相比,使用 NOACs 可显著降低 AF 消融患者的出血风险。同样,不间断使用 NOACs 比不间断使用 VKA 以及间断使用 NOACs 比间断使用 VKA 出血风险更低。两组患者的血栓栓塞并发症发生率均极低,且无差异。

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