{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T22:05:43Z","timestamp":1775340343178,"version":"3.50.1"},"reference-count":22,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,6,4]]},"abstract":"<jats:sec sec-type=\"background\" xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">Days alive out of hospital (DAOH) is an objective and patient\u2010centered net benefit end point. There are no assessments of DAOH in clinical trials of interventions for atrial fibrillation (AF), and it is not known whether this end point is of clinical utility in these populations.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) was an international double\u2010blind, double\u2010dummy randomized clinical trial that compared rivaroxaban with warfarin in patients with atrial fibrillation at increased risk for stroke. We assessed DAOH using investigator\u2010reported event data for up to 12\u2009months after randomization in ROCKET AF. We assessed DAOH overall, by treatment group, and by subgroup, including age, sex, and comorbidities, using Poisson regression. The mean\u00b1SD number of days dead was 7.3\u00b141.2, days hospitalized was 1.2\u00b17.2, and mean DAOH was 350.7\u00b156.2, with notable left skew. Patients with comorbidities had fewer DAOH overall. There were no differences in DAOH by treatment arm, with mean DAOH of 350.6\u00b156.5 for those randomized to rivaroxaban and 350.7\u00b155.8 for those randomized to warfarin (\n              <jats:italic>P<\/jats:italic>\n              =0.86). A sensitivity analysis found no difference in DAOH not disabled with rivaroxaban versus warfarin (DAOH not disabled, 349.2\u00b159.5\u2009days and 349.1\u2009days\u00b159.3\u2009days, respectively,\n              <jats:italic>P<\/jats:italic>\n              =0.88).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">DAOH did not identify a treatment difference between patients randomized to rivaroxaban versus warfarin. This may be driven in part by the low overall event rates in atrial fibrillation anticoagulation trials, which leads to substantial left skew in measures of DAOH.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.122.028951","type":"journal-article","created":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T12:18:31Z","timestamp":1716466711000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Assessment of Days Alive Out of Hospital as a Possible End Point in Trials of Stroke Prevention for Atrial Fibrillation: A ROCKET AF Analysis"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5169-117X","authenticated-orcid":false,"given":"Josephine","family":"Harrington","sequence":"first","affiliation":[{"name":"Duke Clinical Research Institute, Duke University Durham NC USA"},{"name":"Division of Cardiology, Department of Medicine Duke University School of Medicine Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0919-4502","authenticated-orcid":false,"given":"Anne S.","family":"Hellkamp","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3791-2148","authenticated-orcid":false,"given":"Kenneth W.","family":"Mahaffey","sequence":"additional","affiliation":[{"name":"Stanford Center for Clinical Research, Department of Medicine Stanford School of Medicine Stanford CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7574-8900","authenticated-orcid":false,"given":"G\u00fcnter","family":"Breithardt","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine University Hospital M\u00fcnster M\u00fcnster Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8318-5471","authenticated-orcid":false,"given":"Jonathan L.","family":"Halperin","sequence":"additional","affiliation":[{"name":"The Cardiovascular Institute, Mount Sinai Medical Center New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6044-7328","authenticated-orcid":false,"given":"Graeme J.","family":"Hankey","sequence":"additional","affiliation":[{"name":"Medical School, Faculty of Health and Medical Sciences The University of Western Australia Perth WA Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9878-7707","authenticated-orcid":false,"given":"Richard C.","family":"Becker","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Health and Diseases University of Cincinnati Heart, Lung &amp; Vascular Institute Cincinnati OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6396-7022","authenticated-orcid":false,"given":"Christopher C.","family":"Nessel","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Janssen, Pharmaceutical Companies of Johnson &amp; Johnson Raritan PA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9428-4408","authenticated-orcid":false,"given":"Scott D.","family":"Berkowitz","sequence":"additional","affiliation":[{"name":"CPC Clinical Research and University of Colorado School of Medicine Denver CO USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0140-2752","authenticated-orcid":false,"given":"Keith A. A.","family":"Fox","sequence":"additional","affiliation":[{"name":"Centre for Cardiovascular Science University of Edinburgh Edinburgh Scotland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6145-4848","authenticated-orcid":false,"given":"Daniel E.","family":"Singer","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine Massachusetts General Hospital Boston MA USA"},{"name":"Harvard Medical School Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8068-2440","authenticated-orcid":false,"given":"Shaun G.","family":"Goodman","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine, St. Michael\u2019s Hospital Canadian Heart Research Centre, University of Toronto Toronto Ontario Canada"},{"name":"Department of Medicine, Canadian VIGOUR Centre University of Alberta Edmonton Alberta Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2393-0855","authenticated-orcid":false,"given":"Manesh R.","family":"Patel","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University Durham NC USA"},{"name":"Division of Cardiology, Department of Medicine Duke University School of Medicine Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0772-2404","authenticated-orcid":false,"given":"Jonathan P.","family":"Piccini","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University Durham NC USA"},{"name":"Division of Cardiology, Department of Medicine Duke University School of Medicine Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_1_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1107039"},{"key":"e_1_3_1_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009638"},{"key":"e_1_3_1_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0905561"},{"key":"e_1_3_1_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1310907"},{"key":"e_1_3_1_6_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000041"},{"key":"e_1_3_1_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rec.2016.11.033"},{"key":"e_1_3_1_8_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu205"},{"key":"e_1_3_1_9_2","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6947-13-S2-S14"},{"key":"e_1_3_1_10_2","doi-asserted-by":"publisher","DOI":"10.1160\/TH13-05-0424"},{"key":"e_1_3_1_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-017-0440-8"},{"key":"e_1_3_1_12_2","doi-asserted-by":"publisher","DOI":"10.1160\/TH16-10-0787"},{"key":"e_1_3_1_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/ehjqcco\/qcaa040"},{"key":"e_1_3_1_14_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.118.004755"},{"key":"e_1_3_1_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2021.03.016"},{"key":"e_1_3_1_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2011.08.003"},{"key":"e_1_3_1_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2009.11.025"},{"key":"e_1_3_1_18_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2010.03975.x"},{"key":"e_1_3_1_19_2","doi-asserted-by":"publisher","DOI":"10.1177\/1536867X1101100106"},{"key":"e_1_3_1_20_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/eht483"},{"key":"e_1_3_1_21_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-049933"},{"key":"e_1_3_1_22_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-151-5-200909010-00003"},{"key":"e_1_3_1_23_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehr352"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.122.028951","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,4]],"date-time":"2024-06-04T16:36:29Z","timestamp":1717518989000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.122.028951"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,4]]},"references-count":22,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,6,4]]}},"alternative-id":["10.1161\/JAHA.122.028951"],"URL":"https:\/\/doi.org\/10.1161\/jaha.122.028951","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,4]]},"assertion":[{"value":"2022-11-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-16","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e028951"}}