{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T16:23:57Z","timestamp":1792686237595,"version":"4.5.0"},"reference-count":17,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,2,6]]},"abstract":"\n Background<\/jats:title>\n The ELDERCARE\u2010AF trial showed that low\u2010dose edoxaban benefits elderly patients with nonvalvular atrial fibrillation considered ineligible for standard oral anticoagulants due to high bleeding risk, but whether this applied to patients with extremely low body weight was unclear.<\/jats:p>\n <\/jats:sec>\n \n Methods and Results<\/jats:title>\n \n This was a prespecified subanalysis by body weight (\u226445, >45\u2009kg) of the phase 3, multicenter, randomized, double\u2010blind, placebo\u2010controlled, event\u2010driven ELDERCARE\u2010AF trial, which compared low\u2010dose edoxaban (15\u2009mg once daily) with placebo in Japanese patients considered ineligible for oral anticoagulants at the recommended therapeutic strength or the approved doses. The primary efficacy and safety end points were stroke or systemic embolism and major bleeding (International Society on Thrombosis and Hemostasis definition), respectively. The \u226445\u2010kg weight group included 374\/984 patients (38.0%), and the >45\u2010kg group included 610\/984 patients (62.0%). The stroke or systemic embolism rate was lower with edoxaban than placebo in both weight groups (\u226445\u2009kg: hazard ratio [HR], 0.36 [95% CI, 0.16\u20130.80]; >45\u2009kg: HR, 0.31 [95% CI, 0.13\u20130.73]; interaction\n P<\/jats:italic>\n =0.82). Major bleeding incidence was numerically higher with edoxaban than placebo (\u226445\u2009kg: HR, 3.05 [95% CI, 0.84\u201311.11]; >45\u2009kg: HR, 1.40 [95% CI, 0.56\u20133.48), with no interaction with body weight (interaction\n P<\/jats:italic>\n =0.33). All\u2010cause mortality was higher in the \u226445\u2010kg group, with no significant difference between treatment groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The benefit of edoxaban 15 mg was consistent in elderly patients with atrial fibrillation and extremely low body weight, though clinicians must remain vigilant about the risk of major bleeding, especially gastrointestinal bleeding.<\/jats:p>\n <\/jats:sec>\n \n Registration Information<\/jats:title>\n \n ClinicalTrials.gov<\/jats:ext-link>\n . Identifier: NCT02801669.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/jaha.123.031506","type":"journal-article","created":{"date-parts":[[2024,1,19]],"date-time":"2024-01-19T06:37:45Z","timestamp":1705646265000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Efficacy and Safety of Low\u2010Dose Edoxaban by Body Weight in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the Randomized ELDERCARE\u2010AF Trial"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2348-7646","authenticated-orcid":false,"given":"Masaharu","family":"Akao","sequence":"first","affiliation":[{"name":"Department of Cardiology National Hospital Organization Kyoto Medical Center Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2544-8464","authenticated-orcid":false,"given":"Takeshi","family":"Yamashita","sequence":"additional","affiliation":[{"name":"The Cardiovascular Institute Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8723-7489","authenticated-orcid":false,"given":"Masayuki","family":"Fukuzawa","sequence":"additional","affiliation":[{"name":"Cardiovascular Group, Primary Medical Science Department, Japan Business Unit, Daiichi Sankyo Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9549-9817","authenticated-orcid":false,"given":"Takuya","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Data Intelligence Group, Data Intelligence Department, Digital Transformation Management Division, Daiichi Sankyo Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3202-7203","authenticated-orcid":false,"given":"Ken","family":"Okumura","sequence":"additional","affiliation":[{"name":"Division of Cardiology Saiseikai Kumamoto Hospital Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/1747493019897870"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2019.00175"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1378\/chest.10-0134"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2012883"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2022.0480"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.121.057190"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0040-1716540"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2017.08.017"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10557-021-07180-4"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.2881"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-14-1245"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.11.051"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/jth.13701"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0905561"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009638"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1107039"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1310907"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.123.031506","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T08:20:59Z","timestamp":1715588459000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.123.031506"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,6]]},"references-count":17,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,2,6]]}},"alternative-id":["10.1161\/JAHA.123.031506"],"URL":"https:\/\/doi.org\/10.1161\/jaha.123.031506","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,6]]},"assertion":[{"value":"2023-06-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-30","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e031506"}}