Hohnloser Stefan H, Calkins Hugh, Willems Stephan, Verma Atul, Schilling Richard, Okumura Ken, Nordaby Matias, Kleine Eva, Biss Branislav, Gerstenfeld Edward P
Department of Cardiology, J. W. Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.
Electrophysiology Laboratory and Arrhythmia Service, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
J Interv Card Electrophysiol. 2019 Aug;55(2):145-152. doi: 10.1007/s10840-019-00518-x. Epub 2019 Feb 13.
To describe regional differences in patient characteristics, ablation procedures, and bleeding events in the RE-CIRCUIT study. RE-CIRCUIT was a prospective, multicenter study that captured data from different regions, providing an opportunity to understand the practices followed in various regions. The incidence of major bleeding events (MBEs) was significantly lower with uninterrupted dabigatran versus uninterrupted warfarin.
Patients were randomized to receive dabigatran 150 mg twice daily or warfarin. Ablation was performed with uninterrupted anticoagulation for 8 weeks after the procedure. Regions were Western Europe, Eastern Europe, North America, and Asia.
Of 704 patients screened across 104 sites, 635 underwent catheter ablation (dabigatran, 317; warfarin, 318). Patient characteristics were different across various regions. Patients from North America had the highest prevalence of atrial flutter (33%), coronary artery disease (29%), diabetes mellitus (18%), and previous myocardial infarction (9%). Hypertension was most prevalent in Eastern Europe (75%), as was congestive heart failure (40% vs 2% in Western Europe). Pulmonary vein isolation alone was the preferred technique used in most patients (86% in North America and 75-83% elsewhere) and radio frequency was the preferred energy source. The major outcome measure, incidence of MBEs during and up to 2 months after the procedure, was consistently lower with uninterrupted dabigatran versus warfarin, irrespective of regions and their procedural differences, and different ablation techniques utilized.
This analysis shows that the benefits of dabigatran over a vitamin K antagonist in patients undergoing atrial fibrillation ablation are consistent across all geographic regions studied.
NCT02348723 (https://clinicaltrials.gov/ct2/show/NCT02348723).
描述RE-CIRCUIT研究中患者特征、消融手术及出血事件的地区差异。RE-CIRCUIT是一项前瞻性多中心研究，收集了不同地区的数据，为了解各地区的实际做法提供了契机。与不间断使用华法林相比，不间断使用达比加群时主要出血事件（MBE）的发生率显著更低。
患者被随机分配接受每日两次150毫克达比加群或华法林治疗。手术后进行8周的不间断抗凝消融治疗。研究地区包括西欧、东欧、北美和亚洲。
在104个研究点筛选的704例患者中，635例接受了导管消融治疗（达比加群组317例，华法林组318例）。不同地区的患者特征存在差异。北美患者中房扑患病率最高（33%），冠心病患病率（29%）、糖尿病患病率（18%）及既往心肌梗死发生率（9%）也最高。高血压在东欧最为普遍（75%），充血性心力衰竭也是如此（东欧为40%，西欧为2%）。大多数患者首选单独肺静脉隔离术（北美为86%，其他地区为75%-83%），射频是首选能量源。主要观察指标，即术后及术后2个月内MBE的发生率，无论地区及其手术差异以及所采用的不同消融技术如何，不间断使用达比加群均始终低于华法林。
该分析表明，在接受房颤消融治疗的患者中，达比加群相对于维生素K拮抗剂的益处在所研究的所有地理区域均是一致的。
NCT02348723（https://clinicaltrials.gov/ct2/show/NCT02348723）
