{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T15:12:06Z","timestamp":1760800326694,"version":"3.41.2"},"reference-count":24,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,3,30]],"date-time":"2020-03-30T00:00:00Z","timestamp":1585526400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100002973","name":"Daiichi-Sankyo","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Eur J Clin Investigation"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>ENSURE\u2010AF (NCT 02072434) assessed therapy with edoxaban vs enoxaparin\u2010warfarin in patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV).<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate clinical features and primary efficacy (composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality during study period) and safety endpoints (composite of major and clinically relevant nonmajor bleeding during on\u2010treatment period) in patients awaiting ECV of AF with a transesophageal echocardiography (TEE)\u2010guided vs a non\u2013TEE\u2010guided strategy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this prospective, randomized, open\u2010label, blinded endpoint study, 2199 patients were randomized to edoxaban 60\u00a0mg once\u2010daily (30\u00a0mg for creatinine clearance 15\u201050\u00a0mL\/min, weight \u226460\u00a0kg and\/or concomitant use of P\u2010glycoprotein inhibitor) or enoxaparin\u2010warfarin. Primary efficacy endpoint and safety endpoint were reported. Associates of TEE use, efficacy endpoint and safety endpoint were explored using multivariable logistic regression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 589 patients from the edoxaban stratum and 594 from the enoxaparin\u2010warfarin stratum were allocated to the TEE\u2010guided strategy. Primary efficacy was similar regardless of TEE approach (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.575). There were no significant differences in bleeding rates, regardless of TEE approach (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.677). Independent predictors of TEE use were as follows: history of ischaemic stroke\/ transient ischaemic attack, hypertension and valvular heart disease. Mean CHA<jats:sub>2<\/jats:sub>DS<jats:sub>2<\/jats:sub>VASc and HAS\u2010BLED score were independent predictors of the efficacy endpoint whilst mean age was an independent predictor of the safety endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Thromboembolic and bleeding events were not different between patients undergoing TEE\u2010guided strategy and in those undergoing an optimized conventional anticoagulation approach for ECV of AF.<\/jats:p><\/jats:sec>","DOI":"10.1111\/eci.13221","type":"journal-article","created":{"date-parts":[[2020,3,9]],"date-time":"2020-03-09T21:34:06Z","timestamp":1583789646000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Comparing TEE\u2010 vs Non\u2013TEE\u2010guided cardioversion of atrial fibrillation: The ENSURE\u2010AF trial"],"prefix":"10.1111","volume":"50","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0384-1975","authenticated-orcid":false,"given":"Monika","family":"Kozie\u0142","sequence":"first","affiliation":[{"name":"Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart &amp; Chest Hospital Liverpool UK"},{"name":"Department of Cardiology, Congenital Heart Diseases and Electrotherapy Division of Medical Sciences in Zabrze Medical University of Silesia Katowice Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jose L.","family":"Merino","sequence":"additional","affiliation":[{"name":"Arrhythmia and Robotic Electrophysiology Unit Hospital Universitario La Paz Universidad Europea Madrid Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raffaele","family":"De Caterina","sequence":"additional","affiliation":[{"name":"Institute of Cardiology University of Pisa Pisa Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kurt","family":"Huber","sequence":"additional","affiliation":[{"name":"3rd Department of Medicine, Cardiology and Intensive Care Medicine Wilhelminenhospital Medical School Sigmund Freud University Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Jin","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo, Inc. Basking Ridge NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Melino","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo, Inc. Basking Ridge NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Goette","sequence":"additional","affiliation":[{"name":"St. Vincenz\u2010Hospital, Paderborn, Paderborn Germany and Working Group: Molecular Electrophysiology University Hospital Magdeburg Magdeburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory Y. H.","family":"Lip","sequence":"additional","affiliation":[{"name":"Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart &amp; Chest Hospital Liverpool UK"},{"name":"Department of Cardiology, Congenital Heart Diseases and Electrotherapy Division of Medical Sciences in Zabrze Medical University of Silesia Katowice Poland"},{"name":"Aalborg Thrombosis Research Unit Department of Clinical Medicine Aalborg University Aalborg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the ENSURE\u2010AF Investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,3,30]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.04.089"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euu189"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw210"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9149(98)00704-8"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.echo.2009.09.015"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200105103441901"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu367"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2018.07.040"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00392-014-0797-9"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euv289"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31474-X"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2015.02.009"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1160\/TH16-11-0876"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.09.062"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.977546"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0905561"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.acvd.2011.11.005"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2013.06.090"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu352"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1160\/th15-07-0532"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1676074"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61233-1"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/ageing\/afl129"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62343-0"}],"container-title":["European Journal of Clinical Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Feci.13221","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/eci.13221","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/eci.13221","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/eci.13221","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T06:37:54Z","timestamp":1693982274000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/eci.13221"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,30]]},"references-count":24,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2020,5]]}},"alternative-id":["10.1111\/eci.13221"],"URL":"https:\/\/doi.org\/10.1111\/eci.13221","archive":["Portico"],"relation":{},"ISSN":["0014-2972","1365-2362"],"issn-type":[{"type":"print","value":"0014-2972"},{"type":"electronic","value":"1365-2362"}],"subject":[],"published":{"date-parts":[[2020,3,30]]},"assertion":[{"value":"2019-11-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e13221"}}