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达比加群酯与华法林用于射频导管消融治疗心房颤动患者的安全性和有效性的Meta 分析。

Safety and efficacy of dabigatran compared with warfarin for patients undergoing radiofrequency catheter ablation of atrial fibrillation: a meta-analysis.

机构信息

Arrhythmia Services, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

出版信息

Can J Cardiol. 2013 Oct;29(10):1203-10. doi: 10.1016/j.cjca.2013.07.005. Epub 2013 Aug 29.

Abstract

BACKGROUND

The safety and efficacy of dabigatran in the periprocedural period for patients undergoing atrial fibrillation ablation is not well established. We conducted a meta-analysis of the periprocedural use of dabigatran vs warfarin (with or without heparin bridging).

METHODS

A literature search was performed using multiple databases. Outcomes were (1) major bleeding; (2) minor bleeding; and (3) thromboembolic events. Odds ratios (ORs) were reported for dichotomous variables.

RESULTS

Eleven controlled studies (9 cohorts, 1 randomized controlled trial and 1 case-control study; 3841 patients) were identified. Dabigatran was used in 1463 patients, uninterrupted in 223 and held up to 36 hours in the remainder. No significant differences were noted in major bleeding rates between dabigatran and warfarin groups (1.9% vs. 1.6%; OR, 1.04 [95% confidence interval (CI), 0.51-2.13]; P = 0.92). Cardiac tamponade was observed in 1.4% in dabigatran vs 1.1% in warfarin groups (OR, 1.1; 95% CI, 0.55-2.11; P = 0.82). Similar rates for dabigatran vs. warfarin were reported for minor bleeding (3.8% vs. 4.5%; OR, 0.85; 95% CI, 0.58-1.25; P = 0.40), hematoma (2% vs. 2.7%; OR, 0.67; 95% CI, 0.41-1.08; P = 0.1), and thromboembolic events (0.6% vs. 0.1%; OR, 2.51; 95% CI, 0.78-8.11; P = 0.12).

CONCLUSIONS

This meta-analysis suggests that dabigatran and warfarin have similar safety and efficacy overall for periprocedural anticoagulation in patients undergoing radiofrequency atrial fibrillation ablation. Signals were seen favouring dabigatran (for hematomas) and warfarin (for thromboembolic events), but neither was statistically significant because of low event rates. More high-quality data are required to definitively compare the 2 strategies.

摘要

背景

达比加群在房颤消融围手术期的安全性和有效性尚未得到充分证实。我们对达比加群与华法林(桥接或不桥接肝素)在围手术期的使用进行了荟萃分析。

方法

使用多个数据库进行文献检索。主要结局为(1)大出血;(2)小出血;(3)血栓栓塞事件。二分类变量报告比值比(OR)。

结果

共纳入 11 项对照研究(9 项队列研究、1 项随机对照试验和 1 项病例对照研究,共 3841 例患者)。达比加群组 1463 例患者,223 例持续应用,其余 36 小时停药。达比加群组与华法林组大出血发生率无显著差异(1.9%比 1.6%;OR,1.04[95%置信区间(CI)0.512.13];P=0.92)。达比加群组心脏压塞发生率为 1.4%,华法林组为 1.1%(OR,1.1;95%CI,0.552.11;P=0.82)。达比加群组与华法林组小出血(3.8%比 4.5%;OR,0.85;95%CI,0.581.25;P=0.40)、血肿(2%比 2.7%;OR,0.67;95%CI,0.411.08;P=0.1)和血栓栓塞事件(0.6%比 0.1%;OR,2.51;95%CI,0.78~8.11;P=0.12)发生率相似。

结论

本荟萃分析表明,达比加群与华法林在射频消融房颤围手术期抗凝治疗方面总体安全性和疗效相当。达比加群(血肿)和华法林(血栓栓塞事件)有获益趋势,但由于事件发生率低,均无统计学意义。需要更多高质量的数据来明确比较这两种策略。

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