Uninterrupted Pradaxa showed less major bleeding than warfarin in atrial fibrillation patients

Patients studied in the trial were reflective of those undergoing catheter ablation in routine clinical practice, providing highly relevant data to treating physicians.

Important new data from the RE-CIRCUIT study show a better safety profile for Pradaxa (dabigatran etexilate mesylate) compared with warfarin in atrial fibrillation (AFib) patients undergoing catheter ablation. AFib patients who underwent catheter ablation while being treated with uninterrupted Pradaxa experienced less major bleeding and fewer serious adverse events compared to those treated with uninterrupted warfarin. The results were presented in a late-breaking session at the American College of Cardiology 66th Annual Scientific Session in Washington, DC and simultaneously published in the New England Journal of Medicine.

In the RE-CIRCUIT trial, uninterrupted Pradaxa significantly reduced the risk of major bleeding complications compared with uninterrupted warfarin. The trial showed a 5.3% absolute risk reduction in its primary endpoint, with major bleeds occurring in 5/317 of patients receiving Pradaxa versus 22/318 of patients receiving warfarin. Pradaxa showed a similar incidence of minor bleeding complications compared to warfarin. There were no thromboembolic events in patients taking Pradaxa and one in patients taking warfarin. Six hundred and thirty-five patients with paroxysmal or persistent AFib undergoing catheter ablation were included in the RE-CIRCUIT trial. These patients were reflective of the types of patients undergoing the procedure in routine clinical practice, providing relevant new data to treating physicians.

"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."

"The RE-CIRCUIT trial is evidence of Boehringer Ingelheim's commitment to conducting research that can improve our understanding of treatment for atrial fibrillation patients," said Sabine Luik, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are excited to present these results, which we believe will provide valuable insights for physicians treating atrial fibrillation patients undergoing catheter ablation."