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


Journal

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
ISSN: 1532-2092
Titre abrégé: Europace
Pays: England
ID NLM: 100883649

Informations de publication

Date de publication:
27 01 2021
Historique:
received: 11 05 2020
accepted: 19 06 2020
pubmed: 30 11 2020
medline: 27 7 2021
entrez: 29 11 2020
Statut: ppublish

Résumé

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. 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). 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.

Identifiants

pubmed: 33249467
pii: 6010494
doi: 10.1093/europace/euaa199
pmc: PMC7842090
doi:

Substances chimiques

Anticoagulants 0
Pyridines 0
Thiazoles 0
Vitamin K 12001-79-5
Heparin 9005-49-6
edoxaban NDU3J18APO

Banques de données

ClinicalTrials.gov
['NCT02942576']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

65-72

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

Auteurs

Stefan H Hohnloser (SH)

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

A John Camm (AJ)

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.

Riccardo Cappato (R)

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

Hans-Christoph Diener (HC)

Medical Faculty, University Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany.

Hein Heidbüchel (H)

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

Lluís Mont (L)

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

Carlos A Morillo (CA)

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

Hans-Joachim Lanz (HJ)

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

Heiko Rauer (H)

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

Paul-Egbert Reimitz (PE)

Department of Biostatistics & Data Management, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.

Rüdiger Smolnik (R)

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

Josef Kautzner (J)

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

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Classifications MeSH