{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T10:04:29Z","timestamp":1745834669539,"version":"3.37.3"},"reference-count":41,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,7,19]],"date-time":"2017-07-19T00:00:00Z","timestamp":1500422400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100015237","name":"The Medicines Company","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015237","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2017,11,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Selection of valve type and procedural anticoagulant may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non\u2010BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO\u20103 trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>BRAVO\u20103 was a randomized multicenter trial including 500 BE\u2010TAVR and 282 non\u2010BE TAVR patients, randomized to bivalirudin versus UFH. Selection of valve type was at the discretion of the operator but randomization was stratified according to valve type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium type \u22653b bleeding, major vascular complications and all ischemic outcomes at 30\u2010days. Outcomes were adjusted using logistic regression analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the trial cohort, 63.9% were treated with BE valves (<jats:italic>n<\/jats:italic>\u2009=\u2009251 bivalirudin vs. <jats:italic>n<\/jats:italic>\u2009=\u2009249 UFH) and 36.1% with non\u2010BE valves (<jats:italic>n<\/jats:italic>\u2009=\u2009140 bivalirudin vs. <jats:italic>n<\/jats:italic>\u2009=\u2009142 UFH). Patients treated with non\u2010BE valves were older, with higher euroSCORE I. At 30 days, there were nonsignificant differences between the two valve types for adjusted risk of all\u2010cause death (HR 2.07, 95% CI 0.91\u20134.70, <jats:italic>P<\/jats:italic>\u2009=\u20090.084) and major vascular complications (HR 1.78, 95% CI 0.97\u20133.26, <jats:italic>P<\/jats:italic>\u2009=\u20090.062) with non\u2010BE compared with BE valves, but all other outcomes were similar. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared with UFH in non\u2010BE TAVR (<jats:italic>P<\/jats:italic>\u2010interaction\u2009=\u20090.039).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Majority of patients in the BRAVO 3 trial received BE valves. At 30\u2010days, adjusted risk of clinical outcomes was similar with non\u2010BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non\u2010BE TAVR.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.27154","type":"journal-article","created":{"date-parts":[[2017,5,12]],"date-time":"2017-05-12T15:02:43Z","timestamp":1494601363000},"page":"1016-1026","source":"Crossref","is-referenced-by-count":7,"title":["Effect of valve design and anticoagulation strategy on 30\u2010day clinical outcomes in transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial"],"prefix":"10.1002","volume":"90","author":[{"given":"Axel","family":"Linke","sequence":"first","affiliation":[{"name":"Department of Internal Medicine\/Cardiology University of Leipzig, Heart Centre  Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8776-326X","authenticated-orcid":false,"given":"Jaya","family":"Chandrasekhar","sequence":"additional","affiliation":[{"name":"Division of Cardiology The Zena and Michael A. 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