Data from Pharmawand - Curated by EPG Health - Date added 20 March 2017
New data from the RE-CIRCUIT study show a better safety profile for Pradaxa (dabigatran etexilate mesylate), from Boehringer, compared to 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.
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 (77.2% relative risk reduction). Pradaxa showed a similar incidence of minor bleeding complications compared to warfarin (59/317 versus 54/318). 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. The results were presented in a late-breaking session at the American College of Cardiology 66th Annual Scientific Session. Results have also been published in the New England Journal of Medicine.
See: "Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation." Hugh Calkins et al. New England Journal of Medicine, March 19, 2017 DOI: 10.1056/NEJMoa1701005