Division of Cardiovascular Diseases, Cardiovascular Research Institute, Mid America Cardiology, University of Kansas Hospital and Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160-7200, USA.
J Am Coll Cardiol. 2012 Mar 27;59(13):1168-74. doi: 10.1016/j.jacc.2011.12.014. Epub 2012 Feb 1.
The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation.
AF ablation requires optimal periprocedural anticoagulation for minimizing bleeding and thromboembolic complications. The safety and efficacy of dabigatran as a periprocedural anticoagulant for AF ablation are unknown.
We performed a multicenter, observational study from a prospective registry including all consecutive patients undergoing AF ablation in 8 high-volume centers in the United States. All patients receiving dabigatran therapy who underwent AF ablation on periprocedural dabigatran, with the dose held on the morning of the procedure, were matched by age, sex, and type of AF with an equal number of patients undergoing AF ablation with uninterrupted warfarin therapy over the same period.
A total of 290 patients, including 145 taking periprocedural dabigatran and an equal number of matched patients taking uninterrupted periprocedural warfarin, were included in the study. The mean age was 60 years with 79% being male and 57% having paroxysmal AF. Both groups had a similar CHADS(2) score, left atrial size, and left ventricular ejection fraction. Three thromboembolic complications (2.1%) occurred in the dabigatran group compared with none in the warfarin group (p = 0.25). The dabigatran group had a significantly higher major bleeding rate (6% vs. 1%; p = 0.019), total bleeding rate (14% vs. 6%; p = 0.031), and composite of bleeding and thromboembolic complications (16% vs. 6%; p = 0.009) compared with the warfarin group. Dabigatran use was confirmed as an independent predictor of bleeding or thromboembolic complications (odds ratio: 2.76, 95% confidence interval: 1.22 to 6.25; p = 0.01) on multivariate regression analysis.
In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.
本研究旨在评估围手术期达比加群在房颤（AF）消融中的可行性和安全性。
AF 消融需要最佳的围手术期抗凝治疗，以最大限度地减少出血和血栓栓塞并发症。达比加群作为 AF 消融的围手术期抗凝剂的安全性和有效性尚不清楚。
我们进行了一项多中心、观察性研究，纳入了来自美国 8 个高容量中心的前瞻性注册中所有连续接受 AF 消融的患者。所有接受达比加群治疗并在围手术期使用达比加群的患者，在手术当天早上停药，并根据年龄、性别和 AF 类型与同期接受不间断华法林治疗的患者进行匹配，每组各有 145 例患者。
共纳入 290 例患者，其中 145 例接受围手术期达比加群治疗，另有 145 例接受不间断围手术期华法林治疗的匹配患者。患者平均年龄为 60 岁，79%为男性，57%为阵发性 AF。两组的 CHADS2 评分、左心房大小和左心室射血分数相似。达比加群组发生 3 例血栓栓塞并发症（2.1%），华法林组无血栓栓塞并发症（p = 0.25）。达比加群组大出血发生率（6%比 1%；p = 0.019）、总出血发生率（14%比 6%；p = 0.031）和出血与血栓栓塞并发症复合发生率（16%比 6%；p = 0.009）均显著高于华法林组。多变量回归分析证实，达比加群的使用是出血或血栓栓塞并发症的独立预测因素（比值比：2.76，95%置信区间：1.22 至 6.25；p = 0.01）。
在接受 AF 消融的患者中，与不间断华法林治疗相比，围手术期使用达比加群显著增加出血或血栓栓塞并发症的风险。
