{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T23:53:22Z","timestamp":1781222002486,"version":"3.54.1"},"reference-count":33,"publisher":"Georg Thieme Verlag KG","issue":"08","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Semin Thromb Hemost"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The prevalence of both atrial fibrillation (AF) and obesity has steadily increased. Nonvitamin K antagonist oral anticoagulants (NOACs) have been shown to be more effective and safer than vitamin K antagonists (VKAs) for long-term stroke prevention in patients with nonvalvular AF. There are still limited data in the literature regarding performance of NOACs in obese patients with AF in the \u201creal world.\u201d The aim of our study was to compare the safety and effectiveness of NOACs versus well-controlled VKA therapy in obese AF patients in a \u201creal-world\u201d setting. Here, we have considered patients with AF and obesity (body mass index [BMI]\u2009&gt;\u200930\u2009kg\/m2) on NOAC or VKA therapy included in the multicenter Atrial Fibrillation Research Database (NCT03760874). The occurrence of major bleedings (MBs) and thromboembolic events (composite of ischemic stroke, transient ischemic attack, and systemic embolism) was respectively considered primary safety and effectiveness outcomes. We identified 1,047 AF patients with obesity who received NOAC (n\u2009=\u2009272) or VKA (n\u2009=\u2009775) treatment. After propensity score matching analysis, 248 NOAC and 496 VKA recipients with similar clinical characteristics, including BMI (34.8\u2009\u00b1\u20093.4 in NOAC vs. 35.1\u2009\u00b1\u20093.8 in the VKA group; p\u2009=\u20090.50), were evaluated. The mean follow-up was 39\u2009\u00b1\u20097 months. The incidence rate of thromboembolic events was 1.10 per 100 person-years (0.67 in NOAC vs. 1.28 in the VKA group; hazard ratio [HR]: 0.52; 95% confidence interval [CI]: 0.22\u20131.22; p\u2009=\u20090.19). The incidence rate of MB was 1.9 per 100 person-years (1.1 in NOAC vs. 2.28 in the VKA group; HR: 0.46; 95% CI: 0.24\u20130.88; p\u2009=\u20090.04). The incidence rate of intracranial hemorrhage was 0.4 per 100 person-years (0.27 in NOAC vs. 0.47 in the VKA group; HR: 0.57; 95% CI: 0.12\u20132.73; p\u2009=\u20090.48). A positive net clinical benefit (NCB) of NOACs over VKAs was found (+0.91). Presence of anemia (HR: 1.75; p\u2009=\u20090.003) and concomitant use of antiplatelet drugs (HR: 2.41; p\u2009=\u20090.001) were found to be independent predictors of MB; moreover, age (HR: 1.65; p\u2009=\u20090.003) was an independent predictor of thromboembolic events. Our data support the hypothesis of safe and effective use of NOACs in patients with AF and obesity, justified by a statistically significant lower incidence of MB and a favorable NCB over VKAs.<\/jats:p>","DOI":"10.1055\/s-0040-1715792","type":"journal-article","created":{"date-parts":[[2020,10,26]],"date-time":"2020-10-26T23:50:01Z","timestamp":1603756201000},"page":"970-976","source":"Crossref","is-referenced-by-count":14,"title":["Clinical Performance of Nonvitamin K Antagonist Oral Anticoagulants in Real-World Obese Patients with Atrial Fibrillation"],"prefix":"10.1055","volume":"46","author":[{"given":"Vincenzo","family":"Russo","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Translational Medical Sciences, University of Campania \u201cLuigi Vanvitelli,\u201d Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta","family":"Bottino","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Translational Medical Sciences, University of Campania \u201cLuigi Vanvitelli,\u201d Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Rago","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea Antonio","family":"Papa","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Biagio","family":"Liccardo","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"D'Onofrio","sequence":"additional","affiliation":[{"name":"Departmental Unit of Electrophysiology, Evaluation, and Treatment of Arrhythmias, Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Golino","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Translational Medical Sciences, University of Campania \u201cLuigi Vanvitelli,\u201d Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerardo","family":"Nigro","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Translational Medical Sciences, University of Campania \u201cLuigi Vanvitelli,\u201d Monaldi Hospital, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2020,10,26]]},"reference":[{"issue":"01","key":"ref1","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1016\/S0735-1097(03)00500-X","article-title":"The prevalence of atrial fibrillation in incident stroke cases and matched population controls in Rochester, Minnesota: changes over three decades","volume":"42","author":"T S Tsang","year":"2003","journal-title":"J Am Coll Cardiol"},{"issue":"05","key":"ref3","doi-asserted-by":"crossref","first-page":"e418","DOI":"10.1161\/STROKEAHA.109.576967","article-title":"Excess body weight and incidence of stroke: meta-analysis of prospective studies with 2 million participants","volume":"41","author":"P Strazzullo","year":"2010","journal-title":"Stroke"},{"issue":"22","key":"ref4","doi-asserted-by":"crossref","first-page":"2557","DOI":"10.1001\/archinte.162.22.2557","article-title":"Body mass index and the risk of stroke in men","volume":"162","author":"T Kurth","year":"2002","journal-title":"Arch Intern Med"},{"issue":"13","key":"ref5","doi-asserted-by":"crossref","first-page":"1420","DOI":"10.1001\/archinte.167.13.1420","article-title":"Body mass index, waist circumference, and waist-hip ratio on the risk of total and type-specific stroke","volume":"167","author":"G Hu","year":"2007","journal-title":"Arch Intern 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Yatsuya","year":"2010","journal-title":"Stroke"},{"issue":"05","key":"ref9","doi-asserted-by":"crossref","first-page":"F817","DOI":"10.1152\/ajprenal.2000.278.5.F817","article-title":"Glomerular hemodynamics in severe obesity","volume":"278","author":"A Chagnac","year":"2000","journal-title":"Am J Physiol Renal Physiol"},{"issue":"06","key":"ref10","doi-asserted-by":"crossref","first-page":"1308","DOI":"10.1111\/jth.13323","article-title":"Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH","volume":"14","author":"K Martin","year":"2016","journal-title":"J Thromb Haemost"},{"issue":"01","key":"ref11","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1007\/s11239-012-0811-x","article-title":"Comparison of initial warfarin response in obese patients versus non-obese patients","volume":"36","author":"J L Wallace","year":"2013","journal-title":"J Thromb Thrombolysis"},{"issue":"10","key":"ref12","first-page":"637","article-title":"Effect of body weight on dose of vitamin K antagonists","volume":"108","author":"T H Self","year":"2015","journal-title":"South Med J"},{"issue":"12","key":"ref13","doi-asserted-by":"crossref","first-page":"1139","DOI":"10.1056\/NEJMoa0905561","article-title":"Dabigatran versus warfarin in patients with atrial fibrillation","volume":"361","author":"S J Connolly","year":"2009","journal-title":"N Engl J Med"},{"issue":"10","key":"ref14","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1056\/NEJMoa1009638","article-title":"Rivaroxaban versus warfarin in nonvalvular atrial fibrillation","volume":"365","author":"M R Patel","year":"2011","journal-title":"N Engl J Med"},{"issue":"11","key":"ref15","doi-asserted-by":"crossref","first-page":"981","DOI":"10.1056\/NEJMoa1107039","article-title":"Apixaban versus warfarin in patients with atrial fibrillation","volume":"365","author":"C B Granger","year":"2011","journal-title":"N Engl J 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pharmacokinetics","volume":"1","author":"S J Barsam","year":"2017","journal-title":"Res Pract Thromb Haemost"},{"issue":"06","key":"ref20","doi-asserted-by":"crossref","first-page":"908","DOI":"10.1111\/bcp.12114","article-title":"Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects","volume":"76","author":"V V Upreti","year":"2013","journal-title":"Br J Clin Pharmacol"},{"key":"ref21","first-page":"1199","article-title":"Relationship between body mass index and outcomes in 21,028 patients with atrial fibrillation treated with edoxaban or warfarin in ENGAGE AF-TIMI 48 trial","volume":"37","author":"G Boriani","year":"2016","journal-title":"Eur Heart J"},{"issue":"12","key":"ref22","doi-asserted-by":"crossref","first-page":"1989","DOI":"10.1016\/j.amjcard.2017.03.028","article-title":"Relation of risk of stroke in patients with atrial fibrillation to body mass index (from patients treated with rivaroxaban and warfarin in the rivaroxaban once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation trial)","volume":"119","author":"S R Balla","year":"2017","journal-title":"Am J Cardiol"},{"issue":"38","key":"ref23","doi-asserted-by":"crossref","first-page":"2869","DOI":"10.1093\/eurheartj\/ehw124","article-title":"The 'obesity paradox' in atrial fibrillation: observations from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial","volume":"37","author":"R K Sandhu","year":"2016","journal-title":"Eur Heart J"},{"key":"ref24","first-page":"1111","article-title":"The use of dabigatran according to body mass index: the RE-LY experience","volume":"35","author":"M E Ezekowitz","year":"2014","journal-title":"Eur Heart J"},{"issue":"08","key":"ref25","doi-asserted-by":"crossref","first-page":"565","DOI":"10.1007\/s00392-017-1102-5","article-title":"The 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A systematic review and meta-analysis of non-vitamin K antagonist oral anticoagulant trials","volume":"48","author":"M Proietti","year":"2017","journal-title":"Stroke"},{"issue":"07","key":"ref27","doi-asserted-by":"crossref","first-page":"1322","DOI":"10.1111\/jth.13701","article-title":"Association of body weight with efficacy and safety outcomes in phase III randomized controlled trials of direct oral anticoagulants: a systematic review and meta-analysis","volume":"15","author":"K Boonyawat","year":"2017","journal-title":"J Thromb Haemost"},{"issue":"02","key":"ref28","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1177\/1060028018796604","article-title":"Comparing the efficacy and safety of direct oral anticoagulants with warfarin in the morbidly obese population with atrial fibrillation","volume":"53","author":"K Kido","year":"2019","journal-title":"Ann Pharmacother"},{"key":"ref29","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/j.ijcard.2018.03.060","article-title":"Impact of BMI on clinical outcomes of NOAC therapy in daily care - results of the prospective Dresden NOAC Registry (NCT01588119)","volume":"262","author":"L Tittl","year":"2018","journal-title":"Int J Cardiol"},{"issue":"11","key":"ref30","doi-asserted-by":"crossref","first-page":"2119","DOI":"10.1111\/jth.13140","article-title":"Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH","volume":"13","author":"S Kaatz","year":"2015","journal-title":"J Thromb Haemost"},{"issue":"05","key":"ref31","doi-asserted-by":"crossref","first-page":"297","DOI":"10.7326\/0003-4819-151-5-200909010-00003","article-title":"The net clinical benefit of warfarin anticoagulation in atrial fibrillation","volume":"151","author":"D E Singer","year":"2009","journal-title":"Ann Intern Med"},{"issue":"09","key":"ref32","doi-asserted-by":"crossref","first-page":"963","DOI":"10.1586\/14779072.2015.1071665","article-title":"Nonsteroidal anti-inflammatory drugs and bleeding risk in anticoagulated patients with atrial fibrillation","volume":"13","author":"G Y Lip","year":"2015","journal-title":"Expert Rev Cardiovasc Ther"},{"issue":"03","key":"ref33","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1016\/j.jacc.2018.04.063","article-title":"Concomitant oral anticoagulant and nonsteroidal anti-inflammatory drug therapy in patients with atrial fibrillation","volume":"72","author":"A P Kent","year":"2018","journal-title":"J Am Coll Cardiol"},{"issue":"07","key":"ref34","doi-asserted-by":"crossref","first-page":"e359","DOI":"10.1016\/S2352-3026(19)30086-9","article-title":"Efficacy and safety of direct oral factor Xa inhibitors compared with warfarin in patients with morbid obesity: a single-centre, retrospective analysis of chart data","volume":"6","author":"M Kushnir","year":"2019","journal-title":"Lancet Haematol"}],"container-title":["Seminars in Thrombosis and Hemostasis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0040-1715792.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,12,23]],"date-time":"2020-12-23T23:46:09Z","timestamp":1608767169000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/s-0040-1715792"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,26]]},"references-count":33,"journal-issue":{"issue":"08","published-online":{"date-parts":[[2020,12,23]]},"published-print":{"date-parts":[[2020,11]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0040-1715792","relation":{},"ISSN":["0094-6176","1098-9064"],"issn-type":[{"value":"0094-6176","type":"print"},{"value":"1098-9064","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,26]]}}}