PMID- 33249467 OWN - NLM STAT- MEDLINE DCOM- 20210726 LR - 20210726 IS - 1532-2092 (Electronic) IS - 1099-5129 (Print) IS - 1099-5129 (Linking) VI - 23 IP - 1 DP - 2021 Jan 27 TI - Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial. PG - 65-72 LID - 10.1093/europace/euaa199 [doi] AB - 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. CI - (c) The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology. FAU - Hohnloser, Stefan H AU - Hohnloser SH AD - Division of Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany. FAU - Camm, A John AU - Camm AJ AD - 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. FAU - Cappato, Riccardo AU - Cappato R AD - Department of Cardiovascular Diseases, Arrhythmia and Electrophysiology Research Center, Humanitas Clinical and Research Center, Via A. Manzoni 56, Rozzano, Milan 20089, Italy. FAU - Diener, Hans-Christoph AU - Diener HC AD - Medical Faculty, University Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany. FAU - Heidbuchel, Hein AU - Heidbuchel H AD - Department of Cardiology, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium. FAU - Mont, Lluis AU - Mont L AD - Department of Cardiology, Cardiovascular CIBER, Hospital Clinic, University of Barcelona, Carrer de Villarroel 170, 08003 Barcelona, Spain. FAU - Morillo, Carlos A AU - Morillo CA AD - Division of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, 1403 29th Street NW, Calgary, Alberta T2N 2T9, Canada. FAU - Lanz, Hans-Joachim AU - Lanz HJ AD - Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munchen, Germany. FAU - Rauer, Heiko AU - Rauer H AD - Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munchen, Germany. FAU - Reimitz, Paul-Egbert AU - Reimitz PE AD - Department of Biostatistics & Data Management, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munchen, Germany. FAU - Smolnik, Rudiger AU - Smolnik R AD - Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munchen, Germany. FAU - Kautzner, Josef AU - Kautzner J AD - Department of Cardiology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 140 21 Prague, Czech Republic. LA - eng SI - ClinicalTrials.gov/NCT02942576 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Europace JT - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology JID - 100883649 RN - 0 (Anticoagulants) RN - 0 (Pyridines) RN - 0 (Thiazoles) RN - 12001-79-5 (Vitamin K) RN - 9005-49-6 (Heparin) RN - NDU3J18APO (edoxaban) SB - IM MH - Administration, Oral MH - Anticoagulants/adverse effects MH - *Atrial Fibrillation/diagnosis/drug therapy/surgery MH - *Catheter Ablation/adverse effects MH - Heparin/adverse effects MH - Humans MH - Pyridines MH - Thiazoles MH - Treatment Outcome MH - Vitamin K PMC - PMC7842090 OTO - NOTNLM OT - Ablation OT - Anticoagulant OT - Atrial fibrillation OT - Edoxaban OT - Non-vitamin K antagonist oral anticoagulants OT - Periprocedural anticoagulation EDAT- 2020/11/30 06:00 MHDA- 2021/07/27 06:00 PMCR- 2020/11/29 CRDT- 2020/11/29 20:35 PHST- 2020/05/11 00:00 [received] PHST- 2020/06/19 00:00 [accepted] PHST- 2020/11/30 06:00 [pubmed] PHST- 2021/07/27 06:00 [medline] PHST- 2020/11/29 20:35 [entrez] PHST- 2020/11/29 00:00 [pmc-release] AID - 6010494 [pii] AID - euaa199 [pii] AID - 10.1093/europace/euaa199 [doi] PST - ppublish SO - Europace. 2021 Jan 27;23(1):65-72. doi: 10.1093/europace/euaa199.