A randomized controlled trial of dabigatran versus warfarin for periablation anticoagulation in patients undergoing ablation of atrial fibrillation.

BACKGROUND: We aimed to evaluate the feasibility of an oral direct thrombin inhibitor, dabigatran, as a periprocedural anticoagulant for use with ablation of atrial fibrillation (AF).
METHODS: Consecutive patients scheduled to undergo an AF ablation were randomly assigned to receive dabigatran (n = 45) or warfarin (n = 45) to compare their clinical feasibility. Both of those oral anticoagulants were discontinued the day before the ablation and were resumed after confirming hemostasis of the venipuncture site. A bridging therapy with heparin was not used in either of the patient groups.
RESULTS: Dabigatran was switched to warfarin before the ablation because of dyspepsia in three patients. An occurrence of rebleeding from the venipuncture site was less common in dabigatran-allocated patients than in warfarin-allocated patients (20% vs 44%; P = 0.013). The reduction in the D-dimer level after the initiation of oral anticoagulants was greater in the dabigatran-allocated patients than in the warfarin-allocated patients. The time from the initiation of the anticoagulants to the ablation was significantly shorter in the dabigatran-allocated patients than in the warfarin-allocated patients (43 ± 7 vs 63 ± 13 days; P < 0.0001). There was only one fatal periprocedural complication in a patient receiving warfarin, who had a mesenteric arterial thrombosis after the ablation.
CONCLUSIONS: An anticoagulation strategy with dabigatran may surpass that with warfarin in reducing both the periprocedural risk of minor bleeding and a hypercoagulable state, and the time to ablation in patients undergoing ablation of AF. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

RCT Entities:   Population Interventions Outcomes