AIMS: This post hoc analysis of ELIMINATE-AF evaluated requirements of unfractionated heparin (UFH) and procedure-related bleeding in atrial fibrillation (AF) patients undergoing ablation with uninterrupted edoxaban or vitamin K antagonist (VKA) therapy. METHODS AND RESULTS: Patients were randomized 2:1 to once-daily edoxaban 60 mg (or dose-reduced 30 mg) or dose-adjusted VKA (target international normalized ratio: 2.0-3.0). Uninterrupted anticoagulation was mandated for 21-28 days' pre-ablation and 90 days' post-ablation. During ablation, UFH administration targeted an activated clotting time (ACT) of 300-400 s. Periprocedural bleeding was differentiated between procedure-related (bleeding at puncture side, cardiac tamponade) and unrelated events. Of 614 randomized patients, 553 received study drug and underwent catheter ablation (edoxaban n = 375; VKA n = 178). The median (Q1-Q3) time from last dose to ablation procedure was 14.8 (13.3-16.5) vs. 16.5 (14.8-19.5) h (edoxaban vs. VKA group, respectively). Mean ACT (SD) ≥300 s was observed in 52% edoxaban- vs. 76% VKA-treated patients, despite a higher mean (SD) UFH dose in the edoxaban vs. VKA group [14 261 (6397) IU vs. 11 473 (4300) IU; exploratory P-value < 0.0001]. In the edoxaban group, 13 patients (3.5%) had procedure-related bleeds of whom 9 had received an UFH dose above the median (13 000 IU). In the VKA arm, 7 patients (3.9%) had procedure-related bleeds of whom 3 had received an UFH dose above the median (10 225 IU). CONCLUSION: The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.

Department of Biostatistics and Data Management Daiichi Sankyo Europe GmbH Zielstattstr 48 81379 München Germany

Department of Cardiology Antwerp University Hospital University of Antwerp Wilrijkstraat 10 2650 Edegem Belgium

Department of Cardiology Cardiology Clinical Academic Group Molecular and Clinical Sciences Research Institute St George's University of London Blackshaw Road London SW17 0QT UK

Department of Cardiology Cardiovascular CIBER Hospital Clinic University of Barcelona Carrer de Villarroel 170 08003 Barcelona Spain

Department of Cardiology Institute for Clinical and Experimental Medicine Videnska 1958 9 140 21 Prague Czech Republic

Department of Cardiovascular Diseases Arrhythmia and Electrophysiology Research Center Humanitas Clinical and Research Center Via A Manzoni 56 Rozzano Milan 20089 Italy

Department of Global Medical Affairs Daiichi Sankyo Europe GmbH Zielstattstr 48 81379 München Germany

Division of Cardiology Department of Cardiac Sciences Libin Cardiovascular Institute University of Calgary 1403 29th Street NW Calgary Alberta T2N 2T9 Canada

Division of Clinical Electrophysiology Department of Cardiology Johann Wolfgang Goethe University Theodor Stern Kai 7 60596 Frankfurt am Main Germany

Medical Faculty University Duisburg Essen Hufelandstr 55 45147 Essen Germany

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