WASHINGTON, DC—New results from a study presented at the ACC.17 Scientific Session demonstrated a better safety profile for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) vs. warfarin in atrial fibrillation patients undergoing catheter ablation. Findings were also published in the New England Journal of Medicine.
Catheter ablation is associated with a risk of thromboembolism and bleeding. Anticoagulation pre- during- and post-ablation must be managed carefully to minimize these risks. Pradaxa is a non-vitamin K antagonist oral anticoagulant (NOAC) currently approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The RE-CIRCUIT (Randomised Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of different peri-proCedUral antIcoagulation sTrategies) study was an exploratory, prospective, randomized, open-label, blinded endpoint, multicenter, active-controlled trial that enrolled 704 patients with paroxysmal or persistent atrial fibrillation with 635 undergoing ablation with uninterrupted anticoagulation.
Study patients were randomized to Pradaxa 150mg twice daily or warfarin (target INR 2–3) and remained on this treatment for the trial duration. The primary endpoint was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Hemostasis (ISTH), during the ablation procedure and up to 2 months post-ablation.
The study found that patients with uninterrupted Pradaxa treatment had a significantly reduced risk of major bleeding complications vs. patients with uninterrupted warfarin. There was a 5.3% absolute risk reduction in the primary endpoint, with major bleeds seen in 5 of 317 Pradaxa patients vs. 22 of 318 warfarin patients (relative risk reduction 77.2%).
The incidence of minor bleeding complications was similar for Pradaxa (59 of 317 patients) vs. warfarin (54 of 318 patients), the authors stated. In addition, there were no thromboembolic events in patients taking Pradaxa compared to one event in patients taking warfarin.
Professor Hugh Calkins, of Johns Hopkins Hospital, Baltimore, MD, concluded, ” 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.”
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