New data suggests that uninterrupted dabigatran may be safer than uninterrupted warfarin when treating atrial fibrillation patients undergoing catheter ablation.
The RE-CIRCUIT (Randomised Evaluation of Dabigatran Etexilate Compared to Warfarin in Pulmonary Vein Ablation: assessment of different peri-procedural anticoagulation strategies) Trial was conducted as a prospective, randomized, open label, blinded, end point study and involved 678 patients. Patients were randomly assigned to receive either dabigatran (150 mg twice daily) or warfarin.
Researchers found that patients in the dabigatran group experienced less major bleeding events than the warfarin group. Dabigatran was also associated with less adverse events than warfarin. However, researchers determined that there was no difference in how many patients experienced stroke or systemic embolism.
“A potential limitation of our trial was the open-label design. The different dosing schedule of dabigatran, need for blood testing, and adjustments in the dose of warfarin made blinding clinically impractical. However, all outcome events were independently adjudicated by a blinded events committee. The sample size that would have been required for a formal noninferiority trial was prohibitive,” researchers acknowledged.
“However, the results observed, and the fact that dabigatran was ultimately superior to warfarin with respect to the primary end point, made our observations clinically relevant,” they concluded. “We found that periprocedural anticoagulation with uninterrupted dabigatran (150 mg twice daily) was associated with fewer bleeding events than uninterrupted vitamin K antagonism.”
“These results are exciting news for the medical community,” said Professor Hugh Calkins, Chairman of the RE-CIRCUIT Study Steering Committee and Professor of Cardiology and Director of the Electrophysiology Laboratory and Arrhythmia Service, Johns Hopkins Hospital, Baltimore, USA. “During an ablation procedure, patients are at risk of potential major complications, including stroke and bleeding. Therefore anticoagulation management at the time of AFib ablation is critically important. In RE-CIRCUIT, we have seen that uninterrupted anticoagulation with dabigatran showed significantly lower major bleeding complications than warfarin in atrial fibrillation patients undergoing cardiac ablation.”
For a closer look at this trial, see its full publication in The New England Journal of Medicine.
The RE-CIRCUIT trial was sponsored by Boehringer Ingelheim.