Edoxaban versus warfarin in vitamin K antagonist experienced and naïve patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial
| Autor: | Gregory Y.H. Lip, Søren Pihlkjær Hjortshøj, Assen Goudev, Michael Melino, Andreas Goette, Shannon M Winters, Monika Kozieł, James Jin, Kurt Huber, Naab Al-Saady, Ariel Cohen |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Pyridines medicine.drug_class medicine.medical_treatment Electric Countershock Cardioversion chemistry.chemical_compound Edoxaban Thromboembolism Internal medicine medicine Humans Prospective Studies Stroke Aged Original Paper business.industry Anticoagulant Warfarin Anticoagulants Atrial fibrillation General Medicine Odds ratio Middle Aged Vitamin K antagonist medicine.disease Thiazoles Treatment Outcome chemistry Vitamin K antagonists Cardiology Female Cardiology and Cardiovascular Medicine business Factor Xa Inhibitors Follow-Up Studies medicine.drug |
| Zdroj: | Kozieł, M, Al-Saady, N, Hjortshøj, S P, Goudev, A, Huber, K, Cohen, A, Jin, J, Melino, M, Winters, S M, Goette, A & Lip, G Y H 2020, ' Edoxaban versus warfarin in vitamin K antagonist experienced and naïve patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial ', Clinical Research in Cardiology, vol. 109, no. 8, pp. 1018-1024 . https://doi.org/10.1007/s00392-019-01594-9 CLINICAL RESEARCH IN CARDIOLOGY Clinical Research in Cardiology |
| DOI: | 10.1007/s00392-019-01594-9 |
| Popis: | Background 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. Objectives 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. Methods 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. Results 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). Conclusions 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. |
| Databáze: | OpenAIRE |
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