非桥接的达比加群酯与华法林用于房颤消融
Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation.
机构信息
From Johns Hopkins Medical Institutions, Baltimore (H.C.); Department of Cardiology-Electrophysiology, University Heart Center Hamburg, Hamburg (S.W.), Department of Cardiology, J.W. Goethe University, Frankfurt (S.H.H.), and Boehringer Ingelheim Pharma, Ingelheim am Rhein (M.N.) - all in Germany; Section of Cardiac Electrophysiology, University of California, San Francisco, San Francisco (E.P.G.); University of Toronto, Toronto (A.V.); Barts Heart Centre, Saint Bartholomew's Hospital, London (R.S.), and Biometrics and Data Sciences Department, Boehringer Ingelheim, Bracknell (K.G.) - both in the United Kingdom; Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan (K.O.); St. Louis Heart and Vascular, St. Louis (H.S.); Department of Clinical Operations, Boehringer Ingelheim Regional Center Vienna, Vienna (B.B.); Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (M.A.B.); and Cardiology Department, Miulli Hospital, Acquaviva delle Fonti, Italy (M.G.).
出版信息
N Engl J Med. 2017 Apr 27;376(17):1627-1636. doi: 10.1056/NEJMoa1701005. Epub 2017 Mar 19.
BACKGROUND
Catheter ablation of atrial fibrillation is typically performed with uninterrupted anticoagulation with warfarin or interrupted non-vitamin K antagonist oral anticoagulant therapy. Uninterrupted anticoagulation with a non-vitamin K antagonist oral anticoagulant, such as dabigatran, may be safer; however, controlled data are lacking. We investigated the safety of uninterrupted dabigatran versus warfarin in patients undergoing ablation of atrial fibrillation.
METHODS
In this randomized, open-label, multicenter, controlled trial with blinded adjudicated end-point assessments, we randomly assigned patients scheduled for catheter ablation of paroxysmal or persistent atrial fibrillation to receive either dabigatran (150 mg twice daily) or warfarin (target international normalized ratio, 2.0 to 3.0). Ablation was performed after 4 to 8 weeks of uninterrupted anticoagulation, which was continued during and for 8 weeks after ablation. The primary end point was the incidence of major bleeding events during and up to 8 weeks after ablation; secondary end points included thromboembolic and other bleeding events.
RESULTS
The trial enrolled 704 patients across 104 sites; 635 patients underwent ablation. Baseline characteristics were balanced between treatment groups. The incidence of major bleeding events during and up to 8 weeks after ablation was lower with dabigatran than with warfarin (5 patients [1.6%] vs. 22 patients [6.9%]; absolute risk difference, -5.3 percentage points; 95% confidence interval, -8.4 to -2.2; P<0.001). Dabigatran was associated with fewer periprocedural pericardial tamponades and groin hematomas than warfarin. The two treatment groups had a similar incidence of minor bleeding events. One thromboembolic event occurred in the warfarin group.
CONCLUSIONS
In patients undergoing ablation for atrial fibrillation, anticoagulation with uninterrupted dabigatran was associated with fewer bleeding complications than uninterrupted warfarin. (Funded by Boehringer Ingelheim; RE-CIRCUIT ClinicalTrials.gov number, NCT02348723 .).
背景
房颤的导管消融术通常采用华法林持续抗凝或间断非维生素 K 拮抗剂口服抗凝治疗。非维生素 K 拮抗剂口服抗凝剂（如达比加群）持续抗凝可能更安全，但缺乏对照数据。我们研究了房颤消融术患者持续使用达比加群与华法林的安全性。
方法
这是一项随机、开放标签、多中心、对照试验，采用盲法终点评估，我们将计划接受阵发性或持续性房颤导管消融术的患者随机分配接受达比加群（每日两次 150mg）或华法林（目标国际标准化比值 2.0 至 3.0）。在 4 至 8 周的不间断抗凝后进行消融，消融期间和消融后 8 周继续抗凝。主要终点是消融期间和消融后 8 周内主要出血事件的发生率；次要终点包括血栓栓塞和其他出血事件。
结果
该试验在 104 个地点招募了 704 名患者；635 名患者接受了消融术。两组患者的基线特征均衡。消融期间和消融后 8 周内，达比加群的大出血事件发生率低于华法林（5 例 [1.6%] vs. 22 例 [6.9%]；绝对风险差异，-5.3 个百分点；95%置信区间，-8.4 至-2.2；P<0.001）。达比加群与华法林相比，围手术期心包填塞和腹股沟血肿的发生率较低。两组患者的轻微出血事件发生率相似。华法林组发生 1 例血栓栓塞事件。
结论
在接受房颤消融术的患者中，不间断使用达比加群抗凝与不间断使用华法林相比，出血并发症更少。（由勃林格殷格翰公司资助；RE-CIRCUIT 临床试验.gov 编号，NCT02348723）。
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