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心脏节律装置手术时的非维生素 K 口服抗凝剂:系统评价和荟萃分析。

Non-vitamin K oral anticoagulants at the time of cardiac rhythm device surgery: A systematic review and meta-analysis.

机构信息

Barts Heart Centre, St. Bartholomew's Hospital, London, United Kingdom; Campus Bio-Medico University of Rome, Rome, Italy.

Barts Heart Centre, St. Bartholomew's Hospital, London, United Kingdom.

出版信息

Thromb Res. 2020 Apr;188:90-96. doi: 10.1016/j.thromres.2020.02.007. Epub 2020 Feb 12.

Abstract

INTRODUCTION

Use of non-vitamin K oral anticoagulants (NOACs) has rapidly increased worldwide. We aimed to systematically assess the available evidence regarding the safety and efficacy of NOACs in patients undergoing cardiac implantable electronic device (CIED) surgery.

METHODS

We performed a systematic literature search. Eligible randomised controlled trials and cohort studies were included. The primary outcome measures were clinically significant device-pocket haematoma and thromboembolic events.

RESULTS

A total of 12 studies were included, equating to 2120 patients. The separate pooling of rate of events showed a low incidence of clinically significant device-pocket haematoma, although numerically higher in patients on continued (1.5%; CI0.8-3.0) versus interrupted NOAC (0.9%; CI0.5-1.7). The rate of any device-pocket haematoma was numerically higher in the continued versus interrupted NOAC group (5.4%; CI3.8-7.7 versus 2.4%; CI1.8-3.3). The incidence of thromboembolic events (0.4%; CI0.2-0.8) was low and comparable. From a meta-analysis of 3 studies (equating to 773 subjects) allowing for a comparison of continued versus interrupted NOAC, we found no significant difference between the 2 strategies in terms of clinically significant pocket haematoma (RR1.14; CI0.43-3.06, p = 0.79), thromboembolic complications (RR1.03; CI0.06-16.37, p = 0.98), and any pocket haematoma (RR1.19; CI0.65-2.20, p = 0.57).

CONCLUSION

Use of NOACs at the time of CIEDs surgery appears to be safe, and either strategy of peri-procedure continuation or interruption might be reasonable. However, continuation of NOAC seems to be associated with a numerically higher rate of bleeding complications. Certainty of the evidence is low, and further studies are required to confirm these findings.

摘要

简介

非维生素 K 口服抗凝剂(NOACs)在全球范围内的应用迅速增加。我们旨在系统评估有关 NOAC 在接受心脏植入式电子设备(CIED)手术的患者中的安全性和有效性的现有证据。

方法

我们进行了系统的文献检索。合格的随机对照试验和队列研究均包括在内。主要结局指标是临床显著的设备袋血肿和血栓栓塞事件。

结果

共有 12 项研究纳入,共计 2120 例患者。分别汇总事件发生率表明,临床显著设备袋血肿的发生率较低,但继续(1.5%;CI0.8-3.0)与中断(0.9%;CI0.5-1.7)NOAC 的患者发生率更高。在继续与中断 NOAC 组中,任何设备袋血肿的发生率均更高(5.4%;CI3.8-7.7 与 2.4%;CI1.8-3.3)。血栓栓塞事件的发生率(0.4%;CI0.2-0.8)较低且相似。从 3 项研究(共 773 例患者)的荟萃分析中,我们允许比较继续与中断 NOAC,发现这两种策略在临床显著的口袋血肿方面没有显著差异(RR1.14;CI0.43-3.06,p=0.79),血栓栓塞并发症(RR1.03;CI0.06-16.37,p=0.98)和任何口袋血肿(RR1.19;CI0.65-2.20,p=0.57)。

结论

CIED 手术时使用 NOAC 似乎是安全的,并且在手术过程中继续或中断策略都可能是合理的。然而,继续使用 NOAC 似乎与更高的出血并发症发生率有关。证据的确定性较低,需要进一步的研究来证实这些发现。

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