Optimal interruption time of dabigatran oral administration to ablation (O-A time) in patients with atrial fibrillation: Integrated analysis of 2 randomized controlled clinical trials.

ABSTRACT

BACKGROUND: RE-CIRCUIT (NCT02348723) and ABRIDGE-J (UMIN000013129) are recently published randomized clinical trials showing that anticoagulation therapy with dabigatran during the periprocedural period of catheter ablation (CA) for atrial fibrillation (AF) was associated with fewer complications. However, the dabigatran administration protocols were different (uninterrupted in RE-CIRCUIT and minimally interrupted in ABRIDGE-J). The aim of this present study was to clarify the optimal interruption time of dabigatran Oral administration to Ablation (O-A time). METHODS: We conducted an integrated analysis of the 2 prospective trials. The endpoint of the study was the incidence of major bleeding events during and up to 8 weeks after CA across participants with different O-A times. RESULTS: The 535 patients in the dabigatran groups of the 2 trials were divided into 3 groups based on their O-A times (<8 h, n = 258; 8-24 h, n = 191; >24 h, n = 86). Major bleeding events occurred in 5 patients (1.9%) in the <8 h group, and 3 (3.5%) in the >24 h group; however, no major bleeding events occurred in the 8-24 h group (3 group-comparison, p = 0.026). No thromboembolic complication was observed in any of the 3 O-A time groups. CONCLUSION: In patients undergoing CA for AF using dabigatran as a periprocedural anticoagulant, an O-A time of 8-24 h was associated with no bleeding complications. These data suggest that an O-A time of 8-24 h may be an appropriate option, especially in a low thromboembolic-risk patient.