{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T05:55:31Z","timestamp":1788155731948,"version":"build-2803163510"},"reference-count":23,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"23","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2019,12,3]]},"abstract":"\n Background<\/jats:title>\n \n The\n PROTECT<\/jats:styled-content>\n \u2010\n AF<\/jats:styled-content>\n (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) and\n PREVAIL<\/jats:styled-content>\n (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trials demonstrated noninferiority of left atrial appendage closure (\n LAAC<\/jats:styled-content>\n ) to warfarin for the composite end point of stroke, systemic embolism, or cardiovascular death. This study aims to quantify the net clinical benefit (\n NCB<\/jats:styled-content>\n ) of\n LAAC<\/jats:styled-content>\n versus warfarin, accounting for differences in clinical impact of different event types.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and Results<\/jats:title>\n \n We performed a post hoc analysis of the\n PROTECT<\/jats:styled-content>\n \u2010\n AF<\/jats:styled-content>\n and\n PREVAIL<\/jats:styled-content>\n trials, which randomized atrial fibrillation patients to\n LAAC<\/jats:styled-content>\n or warfarin in a 2:1 fashion. The trials enrolled patients in the United States and Europe between 2005 and 2012 with paroxysmal, persistent, or permanent atrial fibrillation and\n CHADS<\/jats:styled-content>\n 2<\/jats:sub>\n risk scores \u22651. Relative to an index weight for death (1.0), events were assigned weights based on their disabling effect: (1) stroke event weights were based on modified Rankin scores in the base case analyses, and (2) major bleed (0.05) and pericardial effusion (0.05).\n NCB<\/jats:styled-content>\n was calculated as the sum of weight\u2010adjusted events per 100\u00a0patient\u2010years. Among 1114 randomized subjects, the\n NCB<\/jats:styled-content>\n of\n LAAC<\/jats:styled-content>\n was 1.42% per year (95%\n CI<\/jats:styled-content>\n 0.01\u20132.82,\n P<\/jats:italic>\n =0.04) and a relative risk of 0.74 (95%\n CI<\/jats:styled-content>\n 0.56\u20131.00).\n NCB<\/jats:styled-content>\n point estimates favored warfarin early in follow\u2010up, but trended in favor of\n LAAC<\/jats:styled-content>\n after 1 to 2\u00a0years. The benefit of\n LAAC<\/jats:styled-content>\n was preserved across subgroups, with particular benefit observed in the subgroup of prior stroke and without diabetes mellitus.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n This analysis demonstrates long\u2010term\n NCB<\/jats:styled-content>\n of\n LAAC<\/jats:styled-content>\n with Watchman over warfarin therapy, as the upfront risk of periprocedural events is counterbalanced over time by reduced bleeding events and mortality.\n <\/jats:p>\n <\/jats:sec>\n \n Clinical Trial Registration<\/jats:title>\n \n UR<\/jats:styled-content>\n :\n http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n . Unique identifiers:\n NCT<\/jats:styled-content>\n 01182441 and\n NCT<\/jats:styled-content>\n 00129545.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/jaha.119.013525","type":"journal-article","created":{"date-parts":[[2019,11,22]],"date-time":"2019-11-22T10:00:24Z","timestamp":1574416824000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":33,"title":["Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT\u2010AF and PREVAIL Studies"],"prefix":"10.1161","volume":"8","author":[{"given":"Tom F.","family":"Brouwer","sequence":"first","affiliation":[{"name":"Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie\u2010Jos\u00e9e and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY"},{"name":"Department of Clinical and Experimental Cardiology Amsterdam Cardiovascular Sciences Amsterdam UMC University of Amsterdam, Heart Center Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Whang","sequence":"additional","affiliation":[{"name":"Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie\u2010Jos\u00e9e and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Kuroki","sequence":"additional","affiliation":[{"name":"Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie\u2010Jos\u00e9e and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan L.","family":"Halperin","sequence":"additional","affiliation":[{"name":"Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie\u2010Jos\u00e9e and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek Y.","family":"Reddy","sequence":"additional","affiliation":[{"name":"Mount Sinai Heart The Zena and Michael A. Wiener Cardiovascular Institute, and The Marie\u2010Jos\u00e9e and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.0000153002.56324.8c"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.1994.00420130036007"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw210"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/cir.0000000000000041"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-138-10-200305200-00011"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.04.025"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)61343-X"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.10.021"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehs292"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.04.029"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.109.561365"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-155-9-201111010-00004"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.10.010"},{"key":"e_1_3_2_15_2","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team","year":"2015","unstructured":"R Core Team . 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