{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T15:14:16Z","timestamp":1760800456638},"reference-count":17,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2021,6,11]],"date-time":"2021-06-11T00:00:00Z","timestamp":1623369600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015731","name":"Bayer Yakuhin Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015731","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was designed to investigate safety and effectiveness during long-term follow-up of rivaroxaban treatment, using reduced doses compared with other global regions, in Japanese patients with non-valvular atrial fibrillation in real-world clinical practice.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>In this prospective, open-label, single-arm, observational study, 11,308 patients with non-valvular atrial fibrillation newly prescribed rivaroxaban (15\/10 mg once daily) at 1416 sites across Japan were enrolled and followed for a mean of 2.5 years.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>In total, 10,664 and 10,628 patients were included in the safety and effectiveness analyses, respectively. In the safety population, mean (standard deviation) age was 73.1 (9.8) years and Congestive heart failure, Hypertension, Age \u226575 years, Diabetes mellitus, previous Stroke\/TIA (2 points) (CHADS<jats:sub>2<\/jats:sub>) score was 2.2 (1.3). Incidences (95% confidence intervals) of any and major bleeding were 3.77 (3.53\u20134.01) and 1.16 (1.03\u20131.29) events per 100 patient-years, respectively. Age \u226575 years, creatinine clearance &lt;50 mL\/min, diabetes mellitus, and vascular disease were independently associated with incidence of major bleeding. The primary composite effectiveness outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction occurred at an incidence (95% confidence interval) of 1.32 (1.18\u20131.46) events per 100 patient-years. Age \u226575 years, hypertension, prior ischemic stroke\/transient ischemic attack, and concomitant use of antiplatelets were independently associated with incidence of the composite outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>In the XAPASS, a large-scale study involving a broad range of patients with non-valvular atrial fibrillation newly prescribed rivaroxaban using Japan-specific dosage in real-world clinical practice, no unexpected safety or effectiveness concerns were detected during up to 5 years of follow-up.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0251325","type":"journal-article","created":{"date-parts":[[2021,6,11]],"date-time":"2021-06-11T17:37:53Z","timestamp":1623433073000},"page":"e0251325","update-policy":"http:\/\/dx.doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":6,"title":["Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS"],"prefix":"10.1371","volume":"16","author":[{"given":"Takanori","family":"Ikeda","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Ogawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takanari","family":"Kitazono","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jyoji","family":"Nakagawara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuo","family":"Minematsu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susumu","family":"Miyamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Murakawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanghun","family":"Iwashiro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Okayama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiyuki","family":"Sunaya","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazufumi","family":"Hirano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takanori","family":"Hayasaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2021,6,11]]},"reference":[{"issue":"7","key":"pone.0251325.ref001","first-page":"e257","article-title":"ACC\/AHA\/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology\/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society","volume":"114","author":"V Fuster","year":"2006","journal-title":"Circulation"},{"issue":"8","key":"pone.0251325.ref002","doi-asserted-by":"crossref","first-page":"983","DOI":"10.1161\/01.STR.22.8.983","article-title":"Atrial fibrillation as an independent risk factor for stroke: the Framingham Study","volume":"22","author":"PA Wolf","year":"1991","journal-title":"Stroke"},{"issue":"21","key":"pone.0251325.ref003","doi-asserted-by":"crossref","first-page":"2719","DOI":"10.1093\/eurheartj\/ehs253","article-title":"2012 focused update of the ESC Guidelines for the Management of Atrial Fibrillation: an update of the 2010 ESC Guidelines for the Management of Atrial Fibrillation. 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