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Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial

SH. Hohnloser, AJ. Camm, R. Cappato, HC. Diener, H. Heidbüchel, L. Mont, CA. Morillo, HJ. Lanz, H. Rauer, PE. Reimitz, R. Smolnik, J. Kautzner

. 2021 ; 23 (1) : 65-72. [pub] 20210127

Language English Country Great Britain

Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc21026171

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.

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$a Hohnloser, Stefan H $u Division of Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany
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$a 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.
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$a Camm, A John $u Department of Cardiology, Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, Blackshaw Road, London SW17 0QT, UK
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$a Cappato, Riccardo $u Department of Cardiovascular Diseases, Arrhythmia and Electrophysiology Research Center, Humanitas Clinical and Research Center, Via A. Manzoni 56, Rozzano, Milan 20089, Italy
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$a Diener, Hans-Christoph $u Medical Faculty, University Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany
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$a Heidbüchel, Hein $u Department of Cardiology, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium
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$a Lanz, Hans-Joachim $u Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany
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$a Smolnik, Rüdiger $u Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany
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$a Kautzner, Josef $u Department of Cardiology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 140 21 Prague, Czech Republic
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