Ablation perioperative dabigatran in use envisioning in Japan: The ABRIDGE-J Study Design

Abstract

BackgroundCatheter ablation has become a standard treatment strategy for drug-resistant symptomatic non-valvular atrial fibrillation (NVAF). Periprocedural administration of uninterrupted warfarin could reduce the risk of thromboembolic complications. However, only a few retrospective studies have reported on the efficacy and safety of periprocedural dabigatran use. MethodABRIDGE is a prospective, randomized, parallel-group, controlled study that aims to evaluate the efficacy and safety of dabigatran compared with warfarin during the perioperative period of catheter ablation. Patients with drug-resistant paroxysmal NVAF from multiple Japanese ablation centers will be randomized using a 1:1 matrix. The main outcome measures include the incidence of embolism during the perioperative period and presence or absence of an intracardiac thrombus just before ablation. The secondary outcome measures include the incidence of all types of bleeding during the perioperative period, incidence of bleeding or thromboembolic events during the perioperative period and within 6 months after the procedure, duration of hospitalization, vascular death, all-cause mortality, net clinical benefit, and all adverse events. ConclusionIn this study, we aim to evaluate the efficacy and safety of dabigatran compared with warfarin during the perioperative period in candidates for catheter ablation of NVAF. Moreover, we hope to obtain objective data that may guide the selection and usage of anticoagulants during catheter ablation.