Uninterrupted administration of edoxaban vs vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation: Rationale and design of the ELIMINATE-AF study
Language English Country United States Media print-electronic
Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
29663464
PubMed Central
PMC6489708
DOI
10.1002/clc.22918
Knihovny.cz E-resources
- Keywords
- Atrial Fibrillation, Catheter Ablation, Direct Oral Anticoagulant, Direct Oral Anticoagulant Edoxaban, Non-Vitamin K Oral Anticoagulants, Periprocedural,
- MeSH
- Anticoagulants administration & dosage adverse effects MeSH
- Time Factors MeSH
- Stroke diagnostic imaging etiology prevention & control MeSH
- Atrial Fibrillation complications mortality physiopathology surgery MeSH
- Factor Xa Inhibitors administration & dosage adverse effects MeSH
- Brain Ischemia diagnostic imaging etiology prevention & control MeSH
- Catheter Ablation * adverse effects mortality MeSH
- Clinical Protocols MeSH
- Hemorrhage chemically induced MeSH
- Humans MeSH
- Magnetic Resonance Imaging MeSH
- Prospective Studies MeSH
- Pyridines administration & dosage adverse effects MeSH
- Risk Factors MeSH
- Drug Administration Schedule MeSH
- Thiazoles administration & dosage adverse effects MeSH
- Vitamin K antagonists & inhibitors MeSH
- Treatment Outcome MeSH
- Research Design MeSH
- Warfarin administration & dosage adverse effects MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Anticoagulants MeSH
- edoxaban MeSH Browser
- Factor Xa Inhibitors MeSH
- Pyridines MeSH
- Thiazoles MeSH
- Vitamin K MeSH
- Warfarin MeSH
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.
Department of Cardiology Antwerp University Hospital University of Antwerp Antwerp Belgium
Department of Cardiology Hospital Clinic University of Barcelona Barcelona Spain
Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czech Republic
Department of Global Medical Affairs Daiichi Sankyo Europe GmbH Munich Germany
Pharma Development Modeling and Simulation Daiichi Sankyo Basking Ridge New Jersey
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ClinicalTrials.gov
NCT02942576
