{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T22:22:02Z","timestamp":1784154122818,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,2,27]],"date-time":"2025-02-27T00:00:00Z","timestamp":1740614400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Cardiology"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Randomized clinical trials demonstrated similar efficacy and improved safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation (AF). Long\u2010term data in routine clinical practice are needed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Hypothesis<\/jats:title><jats:p>Patients with AF receiving edoxaban at baseline continue to have low annualized effectiveness and safety event rates in the second year of follow\u2010up, with regional variations observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The Global ETNA\u2010AF program is a prospective, noninterventional study of patients with AF receiving edoxaban. Patient characteristics and annualized clinical event rates were assessed overall and by region across the 2\u2010year follow\u2010up. Annualized event rates of bleeding and thromboembolic events were assessed within the first year and conditionally in patients who were event\u2010free up to 12 months in the second year.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This analysis comprised 26 805 patients from Europe (<jats:italic>n<\/jats:italic>\u2009=\u200913\u2009164), Japan (<jats:italic>n<\/jats:italic>\u2009=\u200910\u2009342), and non\u2010Japanese Asian regions (<jats:italic>n<\/jats:italic>\u2009=\u20093299). Patients from Europe had the highest burden of comorbidities. The annualized event rates for major bleeding, any stroke, all\u2010cause death, and cardiovascular death varied by region. The global annualized event rates in the first and second year were 1.31%\/year and 0.86%\/year for major bleeding, 1.06%\/year and 0.65%\/year for any stroke, 0.84%\/year and 0.73%\/year for cardiovascular death, and 3.05%\/year and 3.18%\/year for all\u2010cause death.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Annualized event rates for any stroke and major bleeding remained low through 2\u2010year follow\u2010up for patients with AF receiving edoxaban at baseline. Differences in annualized event rates for all\u2010cause and cardiovascular mortality between Europe, Japan, and non\u2010Japanese Asian regions may reflect variations in baseline characteristics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>Europe, NCT02944019; Japan, UMIN000017011; Korea\/Taiwan, NCT02951039; Hong Kong, NCT03247582; and Thailand, NCT03247569.<\/jats:p><\/jats:sec>","DOI":"10.1002\/clc.70091","type":"journal-article","created":{"date-parts":[[2025,3,8]],"date-time":"2025-03-08T08:33:12Z","timestamp":1741422792000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Two\u2010Year Follow\u2010Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA\u2010AF Program"],"prefix":"10.1002","volume":"48","author":[{"given":"Raffaele","family":"De Caterina","sequence":"first","affiliation":[{"name":"Chair of Cardiology University of Pisa and Cardiology Division, Pisa University Hospital Pisa Italy"},{"name":"Fondazione Villa Serena per la Ricerca Citt\u00e0 Sant'Angelo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Unverdorben","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo, Inc. Basking Ridge USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cathy","family":"Chen","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo, Inc. Basking Ridge USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0411-6372","authenticated-orcid":false,"given":"Eue\u2010Keun","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University College of Medicine and Seoul National University Hospital Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihiro","family":"Koretsune","sequence":"additional","affiliation":[{"name":"National Hospital Organization Osaka National Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doralisa","family":"Morrone","sequence":"additional","affiliation":[{"name":"Department of Surgical Division of Cardiology, Medical and Molecular Pathology and Critical Care Medicine University of Pisa Pisa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ladislav","family":"Pecen","sequence":"additional","affiliation":[{"name":"Institute of Computer Science of the Czech Academy of Sciences Prague Czech Republic"},{"name":"Medical Faculty Charles University Pilsen Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Bramlage","sequence":"additional","affiliation":[{"name":"Institute for Pharmacology and Preventive Medicine Cloppenburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chun\u2010Chieh","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Chang Gung Memorial Hospital Chang Gung University Taoyuan Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Yamashita","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine Cardiovascular Institute Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paulus","family":"Kirchhof","sequence":"additional","affiliation":[{"name":"Center for Cardiovascular Research University of Birmingham and SWBH and UHB NHS Trusts Birmingham UK"},{"name":"Department of Cardiology University Heart and Vascular Center Hamburg Hamburg Germany"},{"name":"German Center for Cardiovascular Research (DZHK) Partner Site Hamburg\/Kiel\/L\u00fcbeck L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,27]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0b013e318266722a"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1310907"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62343-0"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaa612"},{"issue":"5","key":"e_1_2_13_6_1","first-page":"e72","article-title":"2020 ACC\/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines","volume":"143","author":"Otto C. 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