Uninterrupted NOAC superior to warfarin for ablation of AF in the RE-CIRCUIT study
Safety and Efficacy of Uninterrupted Anticoagulation With Dabigatran Etexilate Versus Warfarin in Patients Undergoing Catheter Ablation of Atrial Fibrillation: The RE-CIRCUIT Study
Presented at ACC.17 by Hough CalkinsMar. 19, 2017 - news
Medical guidelines recommend catheter ablation for symptomatic AF as a class 1 or 2 indication, depending on previous antiarrhythmic treatment and AF type. Studies have shown that uninterrupted anticoagulation with a vitamin K antagonist (VKA) contributes to the decrease of the ablation-associated complications stroke, TIA, or cardiac tamponade. However, most AF patients prior to ablation are on non-VKA oral anticoagulation, for which there are limited clinical data in this context.
The objective of the RE-CIRCUIT study was to investigate the safety and efficacy of uninterrupted dabigatran (150 mg twice daily) versus warfarin for peri-procedural anticoagulation in patients undergoing catheter ablation of atrial fibrillation. The prospective randomized multicenter open-label clinical trial enrolled 704 patients across 104 sites in 11 countries between April 2015 and July 2016. 317 patients underwent AF ablation on uninterrupted dabigatran and 318 patients underwent AF ablation on uninterrupted warfarin.
The primary endpoint was the incidence of major bleeding events (MBEs) during and up to 8 weeks after ablation.
- The percentage of patients with MBEs during ablation or in the first 8 weeks after the procedure was significantly lower in the dabigatran group compared with the warfarin group (1.6% vs. 6.9%; absolute risk difference: –5.3%; 95% CI: –8.4 to –2.2; P=0.0009). The RRR versus warfarin was 77.2%.
- Cox proportional-hazards analysis of the primary end point for dabigatran vs. warfarin revealed fewer MBEs from the time of ablation (HR: 0.22; 95% CI: 0.08 - 0.59).
- The incidence of minor bleeding events was similar in the two treatment groups (18.6% in the dabigatran group and 17.0% in the warfarin group).
- From the time of ablation until 8 weeks after ablation, there were no events of stroke, systemic embolism, or TIA in the dabigatran group and only one TIA event in the warfarin group.
- No fatal events were reported in either treatment group.
In AF patients undergoing ablation, periprocedural anticoagulation with uninterrupted dabigatran (150 mg twice daily) was associated with fewer bleeding complications compared with uninterrupted warfarin. The results of this study suggest that uninterrupted dabigatran administration is a better anticoagulation strategy for AF ablation as compared with warfarin. The availability of the specific reversal agent idarucizumab, while not needed in any patient in this trial, further motivates the adoption of uninterrupted dabigatran as the preferred anticoagulation strategy in patients undergoing AF ablation.
The commentator noted during the press conference that this study will most likely affect clinical practice, as it refutes some of the bleeding concerns. Now, a periprocedural strategy is available that is associated with minimal bleeding and reversal at hand.
Our coverage of ACC.17 is based on the information provided during the congress.