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比较利伐沙班与华法林或达比加群在接受导管消融治疗心房颤动患者中的疗效和安全性的荟萃分析。

Meta-analysis of efficacy and safety of rivaroxaban compared with warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation.

机构信息

Department of Internal Medicine, Reading Health System, West Reading, Pennsylvania.

Department of Internal Medicine, Reading Health System, West Reading, Pennsylvania.

出版信息

Am J Cardiol. 2014 Aug 15;114(4):577-82. doi: 10.1016/j.amjcard.2014.05.038. Epub 2014 Jun 6.

Abstract

Several studies have been conducted to study the efficacy and safety of rivaroxaban in the atrial fibrillation periprocedural ablation period with similar rates of thromboembolism and major bleeding risks compared with warfarin or dabigatran. We sought to systematically review this evidence using pooled data from multiple studies. Studies comparing rivaroxaban with warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation were identified through electronic literature searches of MEDLINE, EMBASE, clinicaltrials.gov, and the Cochrane library up to March 2014. Study-specific risk ratios (RRs) were calculated and combined using a random-effects model meta-analysis. In an analysis involving 3,575 patients, thromboembolism (composite of stroke, transient ischemic attack, and systemic and pulmonary emboli) occurred in 3 of 789 patients (0.4%) in the rivaroxaban group and 10 of 2,786 patients (0.4%) in the warfarin group (RR 0.71, 95% CI 0.26 to 1.96, I(2) = 0%, p = 0.51). Major hemorrhage occurred in 9 of 749 patients (1.2%) in the rivaroxaban group and 22 of 975 patients (2.3%) in the warfarin group (RR 0.49, 95% CI 0.24 to 1.02, I(2) = 0%, p = 0.06). Furthermore, direct efficacy and safety comparisons between rivaroxaban and dabigatran showed nonsignificant differences in rates of thromboembolism (0.5% vs 0.4%, respectively, RR 1.12, 95% CI 0.25 to 4.99, I(2) = 0%, p = 0.88) and major bleeding (1.0% vs 1.6%, respectively, RR = 0.71, 95% CI 0.16 to 3.15, I(2) = 22%, p = 0.66). In conclusion, our study suggests that patients treated with rivaroxaban during periprocedural catheter ablation have similar rates of thromboembolic events and major hemorrhage. Similar results were seen in direct comparisons between dabigatran and rivaroxaban.

摘要

已有多项研究比较了利伐沙班与华法林或达比加群在接受导管消融治疗心房颤动患者中的疗效和安全性,结果显示利伐沙班组与华法林组或达比加群组的血栓栓塞和大出血风险相似。我们旨在使用多项研究的汇总数据对此类证据进行系统评价。通过对 MEDLINE、EMBASE、clinicaltrials.gov 和 Cochrane 图书馆进行电子文献检索,截至 2014 年 3 月,我们确定了比较利伐沙班与华法林或达比加群在接受导管消融治疗心房颤动患者中的疗效和安全性的研究。计算了每项研究的风险比(RR),并使用随机效应模型进行荟萃分析合并。在一项涉及 3575 例患者的分析中,利伐沙班组有 3 例(0.4%)患者发生血栓栓塞(包括卒中、短暂性脑缺血发作以及全身和肺栓塞),华法林组有 10 例(0.4%)患者发生血栓栓塞(RR 0.71,95%CI 0.26 至 1.96,I(2) = 0%,p = 0.51)。利伐沙班组有 9 例(1.2%)患者发生大出血,华法林组有 22 例(2.3%)患者发生大出血(RR 0.49,95%CI 0.24 至 1.02,I(2) = 0%,p = 0.06)。此外,利伐沙班与达比加群之间的直接疗效和安全性比较显示,血栓栓塞发生率无显著差异(分别为 0.5%和 0.4%,RR 1.12,95%CI 0.25 至 4.99,I(2) = 0%,p = 0.88),大出血发生率也无显著差异(分别为 1.0%和 1.6%,RR = 0.71,95%CI 0.16 至 3.15,I(2) = 22%,p = 0.66)。综上,本研究提示围手术期导管消融期间接受利伐沙班治疗的患者发生血栓栓塞事件和大出血的风险相似,利伐沙班与达比加群之间的直接比较也得出了相似的结果。

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