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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\u2009+\u20093\u00a0days.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Of 2199 patients enrolled in ENSURE-AF, 1095 were randomised to edoxaban and 1104 to enox\u2013warf. There were numerically fewer primary efficacy endpoint events with edoxaban than enox\u2013warf irrespective of whether VKA experienced or na\u00efve (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\u20136.81 in anticoagulant experienced patients, OR 0.77, 95% CI 0.15\u20133.60 in anticoagulant na\u00efve patients] and in major bleeding rates regardless of treatment or VKA experience (OR 0.69, 95%CI 0.06\u20136.04, OR 0.48, 95% CI 0.01\u20139.25, respectively).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>Edoxaban had comparable efficacy and safety to optimized anticoagulation with enox\u2013warf. The primary efficacy and safety endpoint outcomes were broadly similar between VKA experienced or na\u00efve patients.<\/jats:p>\n<\/jats:sec>","DOI":"10.1007\/s00392-019-01594-9","type":"journal-article","created":{"date-parts":[[2020,1,8]],"date-time":"2020-01-08T09:02:42Z","timestamp":1578474162000},"page":"1018-1024","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Edoxaban versus warfarin in vitamin K antagonist experienced and na\u00efve patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial"],"prefix":"10.1007","volume":"109","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0384-1975","authenticated-orcid":false,"given":"Monika","family":"Kozie\u0142","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naab","family":"Al-Saady","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00f8ren P.","family":"Hjortsh\u00f8j","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Assen","family":"Goudev","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kurt","family":"Huber","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ariel","family":"Cohen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Melino","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shannon M.","family":"Winters","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Goette","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory Y. 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Lip, MD, has served as a consultant for Bayer\/Janssen, Bristol-Myers Squibb\/Pfizer, Biotronik, Medtronic, Boehringer Ingelheim, Novartis, Verseon, and Daiichi Sankyo, and as a speaker for Bayer, Bristol-Myers Squibb\/Pfizer, Medtronic, Boehringer Ingelheim, and Daiichi Sankyo. Monika Kozie\u0142 reported no conflict of interest. Naab Al-Saady, MD, is an employee of Covance, the CRO during the conduction of the study. S\u00f8ren P. Hjortsh\u00f8j, MD, has received honoraria for lectures and participation on advisory boards from Biotronik, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Pfizer. Assen Goudev, MD, has received honoraria for lectures and participation on advisory boards for AstraZeneca, Novartis, and Pfizer. Kurt Huber, MD, has received lecture fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer. Ariel Cohen, MD, reports a research grant from RESICARD; he has served as a consultant for Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer-Ingelheim, Daiichi Sankyo, and Novartis. James Jin, PhD is employed by Daiichi Sankyo Pharma Development. Michael Melino and Shannon M. Winters, MS, were employed by Daiichi Sankyo at the time the study was conducted. Andreas Goette, MD, has served as a consultant for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer, and a speaker for AstraZeneca, Bayer, Berlin-Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Medtronic, Pfizer, and Sanofi-Aventis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}