AIMS: Edoxaban is a direct factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF). Uninterrupted edoxaban therapy in patients undergoing AF ablation has not been tested. METHODS AND RESULTS: The ELIMINATE-AF trial, a multinational, multicentre, randomized, open-label, parallel-group study, was conducted to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for dose reduction) vs. vitamin K antagonists (VKAs) in AF patients undergoing catheter ablation. Patients were randomized 2:1 to edoxaban vs. VKA. The primary endpoint (per-protocol population) was time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding during the period from the end of the ablation procedure to end of treatment (90 days). Overall, 632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent brain magnetic resonance imaging to assess silent cerebral infarcts. The primary endpoint (only major bleeds occurred) was observed in 0.3% (1 patient) on edoxaban and 2.0% (2 patients) on VKA [hazard ratio (95% confidence interval): 0.16 (0.02-1.73)]. In the ablation population (modified intent-to-treat population including patients with ablation), the primary endpoint was observed in 2.7% of edoxaban (N = 10) and 1.7% of VKA patients (N = 3) between start of ablation and end of treatment. There were one ischaemic and one haemorrhagic stroke, both in patients on edoxaban. Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62). CONCLUSION: Uninterrupted edoxaban therapy represents an alternative to uninterrupted VKA treatment in patients undergoing AF ablation.

Arrhythmia and Electrophysiology Research Center Humanitas Clinical and Research Center Via A Manzoni 56 Rozzano Italy

Blackpool Teaching Hospitals NHS Lancashire Cardiac Centre Whinney Heys Road Blackpool UK

Cardiology Clinical Academic Group Molecular and Clinical Sciences Research Institute St George's University of London Blackshaw Road London UK

Daiichi Sankyo Europe GmbH Zielstattstr 48 München Germany

Department of Cardiology Antwerp University Hospital University of Antwerp Wilrijkstraat 10 Edegem Belgium

Department of Cardiology Arrhythmias Unit Ospedale F Miulli Acquaviva delle Fonti Strada Provinciale Acquaviva Santeramo Km4 Acquaviva delle Fonti Bari Italy

Department of Cardiology Hospital Clinic University of Barcelona Carrer de Villarroel 170 Barcelona Spain

Department of Cardiology Institute for Clinical and Experimental Medicine Videnska 1958 9 Prague Czech Republic

Division of Cardiology Department of Cardiac Sciences Libin Cardiovascular Institute University of Calgary 1403 29th Street NW Calgary Alberta Canada

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

Institute for Diagnostic and Interventional Radiology and Neuroradiology University Hospital Essen University Duisburg Essen Hufelandstr 55 Essen Germany

Medical Faculty of the University Duisburg Essen Hufelandstr 55 45147 Essen Germany

Eur Heart J. 2019 Sep 21;40(36):3022-3025. doi: 10.1093/eurheartj/ehz322. PubMed

Eur Heart J. 2019 Sep 21;40(36):3043. doi: 10.1093/eurheartj/ehz630. PubMed

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