Koziel, Monika, Al-Saady, Naab, Hjortshoj, Soren P, Goudev, Assen, Huber, Kurt, Cohen, Ariel, Jin, James, Melino, Michael, Winters, Shannon M, Goette, Andreas et al (show 1 more authors)
(2020)
Edoxaban versus warfarin in vitamin K antagonist experienced and naive patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial.
CLINICAL RESEARCH IN CARDIOLOGY, 109 (8).
pp. 1018-1024.
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Kozieł2020_Article_EdoxabanVersusWarfarinInVitami.pdf - Published version Download (666kB) | Preview |
Abstract
<h4>Background</h4>In ENSURE-AF study, edoxaban had similar efficacy and safety profile versus enoxaparin-warfarin (enox-warf) in patients undergoing electrical cardioversion of non-valvular atrial fibrillation.<h4>Objectives</h4>To evaluate the efficacy and safety of edoxaban versus enox-warf in patients who were vitamin K antagonists (VKA) naïve or experienced at time of randomisation into ENSURE-AF trial.<h4>Methods</h4>The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during the overall study period, 28 days on study drug after cardioversion and 30 days follow-up. The primary safety endpoint was the composite of major and clinically relevant nonmajor bleeding during the on-medication period from time of first dose to last dose of study drug taken + 3 days.<h4>Results</h4>Of 2199 patients enrolled in ENSURE-AF, 1095 were randomised to edoxaban and 1104 to enox-warf. There were numerically fewer primary efficacy endpoint events with edoxaban than enox-warf irrespective of whether VKA experienced or naïve (0.5% vs. 0.9%, 0.3% vs. 1.4%, respectively). There were no significant differences in the primary safety endpoint [odds ratio (OR) 2.09, 95% confidence interval (CI) 0.72-6.81 in anticoagulant experienced patients, OR 0.77, 95% CI 0.15-3.60 in anticoagulant naïve patients] and in major bleeding rates regardless of treatment or VKA experience (OR 0.69, 95%CI 0.06-6.04, OR 0.48, 95% CI 0.01-9.25, respectively).<h4>Conclusions</h4>Edoxaban had comparable efficacy and safety to optimized anticoagulation with enox-warf. The primary efficacy and safety endpoint outcomes were broadly similar between VKA experienced or naïve patients.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Atrial fibrillation, Edoxaban, Vitamin K antagonists |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 27 Aug 2020 13:55 |
| Last Modified: | 18 Jan 2023 23:36 |
| DOI: | 10.1007/s00392-019-01594-9 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3098785 |
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