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Title: Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial
Author: Hohnloser, Stefan H.
Camm, John
Cappato, Riccardo
Diener, Hans-Christoph
Heidbüchel, Hein
Mont Girbau, Lluís
Morillo, Carlos A.
Abozguia, Khalid
Grimaldi, Massimo
Rauer, Heiko
Reimitz, Paul-Egbert
Smolnik, Rüdiger
Mönninghoff, Christoph
Kautzner, Josef
Keywords: Fibril·lació auricular
Anticoagulants (Medicina)
Malalties cerebrovasculars
Atrial fibrillation
Anticoagulants (Medicine)
Cerebrovascular disease
Issue Date: 12-Sep-2019
Publisher: Oxford University Press
Abstract: 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.
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It is part of: European Heart Journal, 2019, vol. 40, num. 36, p. 3013-3021
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ISSN: 0195-668X
Appears in Collections:Articles publicats en revistes (Medicina)

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