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.
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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)
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Copyright | © 2018 Wiley Periodicals, Inc. |
Chemical References |
- Anticoagulants
- Factor Xa Inhibitors
- Pyridines
- Thiazoles
- Vitamin K
- Warfarin
- edoxaban
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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)
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