{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,10]],"date-time":"2025-04-10T12:50:01Z","timestamp":1744289401064,"version":"3.38.0"},"reference-count":25,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,1,7]],"date-time":"2025-01-07T00:00:00Z","timestamp":1736208000000},"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":["Cardiovasc electrophysiol"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Off\u2010label under\u2010 and overdosing of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) is not uncommon in real\u2010world practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>This study aimed to identify efficacy and safety of off\u2010label DOACs dose after AF ablation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The RYOUMA registry was a prospective multicenter study of Japanese patients who underwent AF ablation between 2017 and 2018. DOAC prescriptions were categorized into on\u2010label standard dose, on\u2010label reduced dose, off\u2010label underdose, and off\u2010label overdose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The proportion of off\u2010label doses among patients after AF ablation varied depending on the type of DOAC, ranging from 13.5% to 34.9%. Of 2821 patients, 366 (13.0%) were prescribed an off\u2010label underdose and exhibited significantly higher CHADS<jats:sub>2<\/jats:sub>, CHA<jats:sub>2<\/jats:sub>DS<jats:sub>2<\/jats:sub>\u2010VASc, CHA<jats:sub>2<\/jats:sub>DS<jats:sub>2<\/jats:sub>\u2010VA, HELT\u2010E<jats:sub>2<\/jats:sub>S<jats:sub>2<\/jats:sub>, and HAS\u2010BLED scores, age, concomitant use of antiplatelets, and lower weight when compared to the on\u2010label standard dose (<jats:italic>n<\/jats:italic>\u2009=\u20091809). While the incidence of ischemic stroke after 1 year of off\u2010label underdose was notably low (0.28%), the rate of major bleeding was relatively high (1.7%). Off\u2010label overdose was prescribed to 134 patients (4.8%), who showed a significantly higher incidence of major bleeding (3.0%) compared to on\u2010label standard dose (0.91%; <jats:italic>p<\/jats:italic>\u2009=\u20090.02). The off\u2010label overdose group did not have any particular background and its thromboembolic risk was, conversely, low. The most likely cause of off\u2010label overdose was clinicians potentially overlooking dose criteria, including advanced age, low body weight, and low creatinine clearance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In patients after AF ablation, off\u2010label DOAC overdose was infrequent, but significantly associated with higher incidence of major bleeding during the remote period after AF ablation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>The study was registered as UMIN000026092 (University Hospital Medical Information Network\u2010Clinical Trial Registry).<\/jats:p><\/jats:sec>","DOI":"10.1111\/jce.16560","type":"journal-article","created":{"date-parts":[[2025,1,7]],"date-time":"2025-01-07T11:59:58Z","timestamp":1736251198000},"page":"564-575","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Current Real\u2010World Status of Off\u2010Label Under\u2010 and Over\u2010Dose of Direct Oral Anticoagulants After Atrial Fibrillation Ablation"],"prefix":"10.1111","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3700-4358","authenticated-orcid":false,"given":"Tabito","family":"Kino","sequence":"first","affiliation":[{"name":"Department of Cardiology, Faculty of Medicine University of Tsukuba Tsukuba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akihiko","family":"Nogami","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Faculty of Medicine University of Tsukuba Tsukuba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyoko","family":"Soejima","sequence":"additional","affiliation":[{"name":"Department of Cardiology Kyorin University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kikuya","family":"Uno","sequence":"additional","affiliation":[{"name":"Heart Rhythm Center, Tokyo Heart Rhythm Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2507-5565","authenticated-orcid":false,"given":"Koichiro","family":"Kumagai","sequence":"additional","affiliation":[{"name":"Heart Rhythm Center, Fukuoka Sanno Hospital Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Kurita","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Center Kindai University School of Medicine Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masayuki","family":"Fukuzawa","sequence":"additional","affiliation":[{"name":"Primary Medical Science Department Daiichi Sankyo Co. Ltd. Chuo\u2010ku Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Takita","sequence":"additional","affiliation":[{"name":"Data Intelligence Department Daiichi Sankyo Co. Ltd. Chuo\u2010ku Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoko","family":"Ishizu","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Faculty of Medicine University of Tsukuba Tsukuba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazutaka","family":"Aonuma","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Faculty of Medicine University of Tsukuba Tsukuba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"and other members of the RYOUMA Registry Investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,7]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000659"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.joa.2017.08.001"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-21-0162"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaa612"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/joa3.12772"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euae043"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-22-0290"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15534"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.22.2864"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.09-1584"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehae539"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ\u201020\u20101075"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.10-0134"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2005.01204.x"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fcvm.2021.724301"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.121.007971"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/10760296231179439"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/openhrt-2022-002197"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.121.056355"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1536\/ihj.20-335"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2022-321114"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-99818-4"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.17156"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.123.064556"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehad798"}],"container-title":["Journal of Cardiovascular Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jce.16560","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,13]],"date-time":"2025-03-13T04:13:04Z","timestamp":1741839184000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jce.16560"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,7]]},"references-count":25,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,3]]}},"alternative-id":["10.1111\/jce.16560"],"URL":"https:\/\/doi.org\/10.1111\/jce.16560","archive":["Portico"],"relation":{},"ISSN":["1045-3873","1540-8167"],"issn-type":[{"type":"print","value":"1045-3873"},{"type":"electronic","value":"1540-8167"}],"subject":[],"published":{"date-parts":[[2025,1,7]]},"assertion":[{"value":"2024-10-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}