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非维生素K拮抗剂口服抗凝药与维生素K拮抗剂口服抗凝药在接受心房颤动射频导管消融术患者中的疗效和安全性:一项荟萃分析

Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants versus Vitamin K Antagonist Oral Anticoagulants in Patients Undergoing Radiofrequency Catheter Ablation of Atrial Fibrillation: A Meta-Analysis.

作者信息

Santarpia Giuseppe, De Rosa Salvatore, Polimeni Alberto, Giampà Salvatore, Micieli Mariella, Curcio Antonio, Indolfi Ciro

机构信息

Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy.

Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy; URT-CNR, Department of Medicine, Consiglio Nazionale delle Ricerche, Catanzaro, Italy.

出版信息

PLoS One. 2015 May 14;10(5):e0126512. doi: 10.1371/journal.pone.0126512. eCollection 2015.

Abstract

BACKGROUND

Use of the non-vitamin K antagonist oral anticoagulants (NOACs) is endorsed by current guidelines for stroke prevention in patients with atrial fibrillation (AF). However efficacy and safety of NOACs in patients undergoing catheter ablation (RFCA) of AF has not been well established yet.

OBJECTIVES

To perform a meta-analysis of all studies comparing NOACs and vitamin K antagonist oral anticoagulants (VKAs) in patients undergoing RFCA.

DATA SOURCES

Studies were searched for in PubMed and Google Scholar databases.

STUDY ELIGIBILITY CRITERIA

Studies were considered eligible if: they evaluated the clinical impact of NOACs versus VKAs; they specifically analyzed the use of anticoagulants during periprocedural phase of RFCA; they reported clinical outcome data.

STUDY APPRAISAL AND SYNTHESIS METHODS

25 studies were selected, including 9881 cases. The summary measure used was the risk ratio (RR) with 95% confidence interval (CI). The random-effects or the fixed effect model were used to synthesize results from the selected studies.

RESULTS

There was no significant difference in thromboembolic complications (RR 1.39; p=0.13). Bleeding complications were significantly lower in the NOACs-treated arm as compared to VKAs (RR=0.67, p<0.001). Interestingly, a larger number of thromboembolic events was found in the VKAs-treated arm in those studies where VKAs had been interrupted during the periprocedural phase (RR=0.68; p=ns). In this same subgroup a significantly higher incidence of both minor (RR=0.54; p=0.002) and major bleeding (RR=0.41; p=0.01) events was recorded. Conversely, the incidence of thromboembolic events in the VKAs-treated arm was significantly lower in those studies with uninterrupted periprocedural anticoagulation treatment (RR=1.89; p=0.02).

LIMITATIONS

As with every meta-analysis, no patients-level data were available.

CONCLUSIONS AND IMPLICATIONS

The use of NOACs in patients undergoing RFCA is safe, given the lower incidence of bleedings observed with NOACs. On the other side, periprocedural interruption of VKAs and bridging with heparin is associated with a higher bleeding rate with no significant benefit on onset of thromboembolic events.

摘要

背景

非维生素K拮抗剂口服抗凝药(NOACs)的使用得到了当前心房颤动(AF)患者卒中预防指南的认可。然而,NOACs在接受导管消融(RFCA)的AF患者中的疗效和安全性尚未得到充分证实。

目的

对所有比较接受RFCA的患者使用NOACs和维生素K拮抗剂口服抗凝药(VKAs)的研究进行荟萃分析。

数据来源

在PubMed和谷歌学术数据库中检索研究。

研究纳入标准

若研究符合以下条件,则被认为合格:评估了NOACs与VKAs的临床影响;专门分析了RFCA围手术期抗凝药的使用情况;报告了临床结局数据。

研究评估与综合方法

选择了25项研究,包括9881例病例。使用的汇总指标是风险比(RR)及95%置信区间(CI)。采用随机效应模型或固定效应模型对所选研究结果进行综合分析。

结果

血栓栓塞并发症方面无显著差异(RR = 1.39;p = 0.13)。与VKAs相比,接受NOACs治疗的组出血并发症显著更低(RR = 0.67,p < 0.001)。有趣的是,在那些围手术期VKAs被中断的研究中,接受VKAs治疗的组出现了更多的血栓栓塞事件(RR = 0.68;p = 无统计学意义)。在同一亚组中,轻微出血(RR = 0.54;p = 0.002)和严重出血(RR = 0.41;p = 0.01)事件的发生率均显著更高。相反,在那些围手术期抗凝治疗未中断的研究中,接受VKAs治疗的组血栓栓塞事件的发生率显著更低(RR = 1.89;p = 0.02)。

局限性

与每项荟萃分析一样,没有患者层面的数据。

结论与启示

鉴于观察到接受NOACs治疗的患者出血发生率更低,在接受RFCA的患者中使用NOACs是安全的。另一方面,围手术期中断VKAs并用肝素桥接与更高的出血率相关,且对血栓栓塞事件的发生没有显著益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c735/4431735/156c2d5f43bc/pone.0126512.g001.jpg

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