Hohnloser, SH;
Camm, J;
Cappato, R;
Diener, H-C;
Heidbüchel, H;
Mont, L;
Morillo, CA;
Abozguia, K;
Grimaldi, M;
Rauer, H;
et al.
Hohnloser, SH; Camm, J; Cappato, R; Diener, H-C; Heidbüchel, H; Mont, L; Morillo, CA; Abozguia, K; Grimaldi, M; Rauer, H; Reimitz, P-E; Smolnik, R; Mönninghoff, C; Kautzner, J
(2019)
Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial.
Eur Heart J, 40 (36).
pp. 3013-3021.
ISSN 1522-9645
https://doi.org/10.1093/eurheartj/ehz190
SGUL Authors: Camm, Alan John
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.
Item Type: |
Article
|
Additional Information: |
© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact
journals.permissions@oup.com |
Keywords: |
Ablation, Anticoagulation, Atrial fibrillation, Bleeding events, Stroke, 1102 Cardiovascular Medicine And Haematology, Cardiovascular System & Hematology |
SGUL Research Institute / Research Centre: |
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) |
Journal or Publication Title: |
Eur Heart J |
ISSN: |
1522-9645 |
Language: |
eng |
Dates: |
Date | Event |
---|
21 September 2019 | Published | 11 April 2019 | Published Online | 25 March 2019 | Accepted |
|
Publisher License: |
Creative Commons: Attribution-Noncommercial 4.0 |
PubMed ID: |
30976787 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/110820 |
Publisher's version: |
https://doi.org/10.1093/eurheartj/ehz190 |
Statistics
Item downloaded times since 17 Apr 2019.
Actions (login required)
![Edit Item](/style/images/action_view.png) |
Edit Item |