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However, information regarding the characteristics and clinical outcomes among such patients is limited. Thus, this study aimed to clarify the characteristics and event rates in elderly patients with NVAF and HBR defined by the ELDERCARE-AF criteria. Of the 7406 NVAF outpatients included in the J-RHYTHM Registry, 60 patients with creatinine clearance (CrCl)\u2009&lt;\u200915\u00a0mL\/min were excluded. The remaining 7346 patients (age, 69.7\u2009\u00b1\u20099.9\u00a0years; men, 70.9%; warfarin use, 78.7%) were divided into three groups: Group 1, aged\u2009&lt;\u200980\u00a0years (<jats:italic>n<\/jats:italic>\u2009=\u20096165); Group 2, aged\u2009\u2265\u200980\u00a0years without HBR (<jats:italic>n<\/jats:italic>\u2009=\u2009584); and Group 3, aged\u2009\u2265\u200980\u00a0years with HBR (at least one of the followings; CrCl, 15\u201330\u00a0mL\/min, history of bleeding, body weight\u2009\u2264\u200945\u00a0kg, and antiplatelet use) (<jats:italic>n<\/jats:italic>\u2009=\u2009597, eligible for 15-mg edoxaban). Patients in Group 3 had a higher prevalence of comorbidities, and therefore, both higher thromboembolic and bleeding risk scores than in the other groups. During the 2-year follow-up period, the incidence rates (per 100 person-years) of thromboembolism in Groups 1, 2, and 3 were 0.7, 1.5, and 2.1 (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001), major hemorrhage, 0.8, 1.2, and 2.0 (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001), and all-cause death, 0.8, 2.6, and 4.6 (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001), respectively. Adjusted hazard ratios of Group 3 were 1.64 (95% confidence interval 0.89\u20133.04, <jats:italic>P<\/jats:italic>\u2009=\u20090.116) for thromboembolism, 1.53 (0.85\u20132.72, <jats:italic>P<\/jats:italic>\u2009=\u20090.154) for major hemorrhage, and 1.84 (1.19\u20132.85, <jats:italic>P<\/jats:italic>\u2009=\u20090.006) for all-cause death compared with Group 1. The NVAF Patients aged\u2009\u2265\u200980\u00a0years with HBR defined by the ELDERCARE-AF criteria were certainly at a higher adverse event risk, especially for all-cause death. <jats:italic>Clinical trial registration<\/jats:italic>: The J-RHYTHM Registry is registered in the University Hospital Medicine Information Network (UMIN) Clinical Trials Registry (unique identifier: UMIN000001569) <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.umin.ac.jp\/ctr\/\">http:\/\/www.umin.ac.jp\/ctr\/<\/jats:ext-link>.<\/jats:p>","DOI":"10.1007\/s00380-023-02343-9","type":"journal-article","created":{"date-parts":[[2023,12,16]],"date-time":"2023-12-16T07:01:42Z","timestamp":1702710102000},"page":"330-339","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Characteristics and outcomes in elderly patients with non-valvular atrial fibrillation and high bleeding risk: subanalysis of the J-RHYTHM Registry"],"prefix":"10.1007","volume":"39","clinical-trial-number":[{"clinical-trial-number":"umin000001569","registry":"10.18810\/umin-japan"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4271-3186","authenticated-orcid":false,"given":"Eitaro","family":"Kodani","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Inoue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotsugu","family":"Atarashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Okumura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Yamashita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Origasa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the J-RHYTHM Registry Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,12,16]]},"reference":[{"key":"2343_CR1","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1161\/CIRCULATIONAHA.105.595140","volume":"114","author":"Y Miyasaka","year":"2006","unstructured":"Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS (2006) Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. 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Dr. Origasa received remuneration from Johnson & Johnson. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}