Uninterrupted administration of edoxaban vs vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation: Rationale and design of the ELIMINATE-AF study.

Abstract

Patients with atrial fibrillation (AF) are at an approximately 0.5% to 3% increased risk of thromboembolism during and immediately after catheter ablation. Treatment guidelines recommend periprocedural oral anticoagulation plus unfractionated heparin during ablation. Rivaroxaban and dabigatran are the only non-vitamin K oral anticoagulants for which there are randomized controlled trials assessing uninterrupted anticoagulation in patients undergoing catheter ablation of AF. Edoxaban, a direct factor Xa inhibitor, is noninferior vs warfarin for the prevention of stroke or systemic embolism with less major bleeding in patients with nonvalvular AF. The ELIMINATE-AF (Evaluation of Edoxaban Compared With VKA in Subjects Undergoing Catheter Ablation of Nonvalvular Atrial Fibrillation) trial is a multinational, multicenter, prospective, randomized, open-label, parallel-group, blinded-endpoint evaluation (PROBE) study to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for a dose reduction) vs vitamin K antagonists (VKA) in patients with nonvalvular AF undergoing catheter ablation (http://www.ClinicalTrials.gov: NCT02942576). A total of 560 patients are planned for randomization to edoxaban or VKA (2:1 ratio) to obtain 450 patients fully compliant with the protocol. Patients will complete 21 to 28 days of anticoagulation prior to the ablation and a 90-day post-ablation period. The primary efficacy endpoint is the composite of all-cause death, stroke, and major bleeding. The primary safety endpoint is major bleeding. A magnetic resonance imaging substudy will assess the incidence of silent cerebral lesions post-ablation. ELIMINATE-AF will define the efficacy and safety of edoxaban for uninterrupted oral anticoagulation during catheter ablation of AF.

• Authors: Stefan H Hohnloser, John Camm, Riccardo Cappato, Hans-Christoph Diener, Hein Heidbuchel, Hans-Joachim Lanz, Lluís Mont, Carlos A Morillo, Rüdiger Smolnik, Ophelia Q P Yin, Josef Kautzner
• Journal: Clinical cardiology (Clin Cardiol) Vol. 41 Issue 4 Pg. 440-449 (Apr 2018) ISSN: 1932-8737 [Electronic] United States
• PMID: 29663464 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2018 Wiley Periodicals, Inc.

Chemical References

• Anticoagulants
• Factor Xa Inhibitors
• Pyridines
• Thiazoles
• Vitamin K
• Warfarin
• edoxaban

Topics

• Anticoagulants (administration & dosage, adverse effects)
• Atrial Fibrillation (complications, mortality, physiopathology, surgery)
• Brain Ischemia (diagnostic imaging, etiology, prevention & control)
• Catheter Ablation (adverse effects, mortality)
• Clinical Protocols
• Drug Administration Schedule
• Factor Xa Inhibitors (administration & dosage, adverse effects)
• Female
• Hemorrhage (chemically induced)
• Humans
• Magnetic Resonance Imaging
• Male
• Prospective Studies
• Pyridines (administration & dosage, adverse effects)
• Research Design
• Risk Factors
• Stroke (diagnostic imaging, etiology, prevention & control)
• Thiazoles (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome
• Vitamin K (antagonists & inhibitors)
• Warfarin (administration & dosage, adverse effects)