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Trial of Periprocedural Anticoagulation for AF Ablation
Study Questions:
What is the safety and efficacy of minimally interrupted dabigatran versus uninterrupted warfarin therapy in patients undergoing catheter ablation for nonvalvular atrial fibrillation (NVAF)?
Methods:
The ABRIDGE-J (ABlation peRIoperative DabiGatran in use Envisioning in Japan) study is an open-label, randomized clinical trial of 442 patients with NVAF undergoing catheter ablation in 28 Japanese centers (504 patients initially screened for inclusion). All patients received anticoagulation for at least 4 weeks prior to and 12 weeks following the ablation procedure. Dabigatran therapy was interrupted for 1-2 doses prior to and resumed immediately following ablation. The primary endpoints were the incidence of embolism in the perioperative period and formation of atrial thrombus prior to ablation. The main secondary endpoint was incident major bleeding within 3 months following ablation.
Results:
Of the 442 patients who underwent ablation, 74.9% were male with a median age of 66 years (interquartile range, 59-71 years). Prior to ablation, one stroke and one left atrial thrombus was identified in the warfarin group. No thrombotic events occurred in the dabigatran group. Following ablation, major bleeding occurred in fewer patients in the dabigatran group as compared to the warfarin group (3/248 [1.4%, 95% confidence interval, 0.4%-4.2%] vs. 11/251 [5.0%, 95% confidence interval, 2.8% vs. 8.8%]; p = 0.03). No post-procedure thromboembolic events occurred in the dabigatran group; one event (0.5%) occurred in the warfarin group.
Conclusions:
The authors concluded that minimally interrupted dabigatran therapy did not increase thromboembolic complications and was associated with fewer major bleeding events than uninterrupted warfarin therapy.
Perspective:
Recent studies have demonstrated safety and efficacy of uninterrupted anticoagulation with direct oral anticoagulants for patients undergoing catheter ablation for NVAF (including the RE-CIRCUIT trial of uninterrupted dabigatran vs. uninterrupted warfarin). Given the relatively short half-lives of these medications, it is reasonable to presume that a brief interruption (1-2 doses) might result in lower periprocedural bleeding risk without an increase in thromboembolic complications. This safety/efficacy profile was confirmed in the ABRIDGE-J study. Two key messages can be taken from this study: 1) Most patients undergoing catheter ablation for NVAF should NOT have their anticoagulation interrupted for more than 1-2 days; and 2) depending on the underlying bleeding risk, patients taking direct oral anticoagulant (e.g., dabigatran) can either undergo catheter ablation without any interruption (low bleed risk patients) or with a 1-2 dose interruption (moderate-high bleed risk). While confirmatory studies with the other direct oral anticoagulants would be welcome, there is no reason to believe that the findings would be any different.
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Catheter Ablation, Embolism, Hemorrhage, Perioperative Period, Stroke, Thromboembolism, Thrombosis, Vascular Diseases, Warfarin
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