title: Sex-based differences in outcomes with bivalirudin or unfractionated heparin for transcatheter aortic valve replacement: Results from the BRAVO-3 randomized trial.
abstract: BACKGROUND
  Women comprise almost 50% of patients undergoing transcatheter aortic valve replacement (TAVR) and previous studies have indicated higher rates of procedural complications and bleeding in women compared to men. It is unknown whether men and women demonstrate a differential response to bivalirudin versus unfractionated heparin (UFH) in TAVR. We sought to evaluate outcomes by sex and type of anticoagulant from the Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement (BRAVO-3) trial of transfemoral TAVR.
  
  
  METHODS
  BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). The primary endpoint was 48 h major bleeding defined as Bleeding Academic Research Consortium (BARC) type ≥3b. Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or stroke. Net adverse cardiovascular events (NACE) were a composite of BARC ≥3b bleeding or 30-day MACE. We examined the outcomes in men and women.
  
  
  RESULTS
  The total cohort included 49% women (n = 391, 195 received bivalirudin and 196 UFH) and 51% men (n = 411, 209 received bivalirudin and 202 UFH). Women were older than men with fewer comorbidities including coronary artery disease, atrial fibrillation, diabetes but similar EuroSCORE I. Women received smaller sheath and device sizes compared with men without differences in the use of vascular closure devices. At 48-hr post-TAVR there was no difference in bleeding or vascular complications in women compared to men. The use of bivalirudin did not result in significantly lower bleeding at 48 hr or 30-days compared to UFH.
  
  
  CONCLUSIONS
  There was no difference in early outcomes with bivalirudin versus UFH in men or women undergoing contemporary TAVR. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Division of Cardiology, Montreal Heart Institute, Montreal, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Asgar
authors.affiliation: Icahn School of Medicine at Mount Sinai, The Zena and Michael a. Wiener Cardiovascular Institute, New York, New York.
authors.forename: J
authors.initials: J
authors.lastname: Chandrasekhar
authors.affiliation: Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom.
authors.forename: G
authors.initials: G
authors.lastname: Mikhail
authors.affiliation: Division of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Webb
authors.affiliation: Ramsay Générale De Santé, Institut Hospitalier Jacques Cartier, Massy, France.
authors.forename: T
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: Department of Cardiology, University of Catania, Catania, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Sussex Cardiac Centre-Brighton & Sussex University Hospitals NHS Trust, Brighton, East Sussex, United Kingdom.
authors.forename: D
authors.initials: D
authors.lastname: Hildick-Smith
authors.affiliation: Department of Cardiology and Angiology, Klinikum Links Der Weser, Bremen, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Hambrecht
authors.affiliation: Centre Hospitalier Universitaire De Lille, Lille, France.
authors.forename: E
authors.initials: E
authors.lastname: Van Belle
authors.affiliation: Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Widder
authors.affiliation: Department of Cardiology, Rangueil University Hospital, Toulouse, France.
authors.forename: N
authors.initials: N
authors.lastname: Dumonteil
authors.affiliation: Cardiology Department, Johannes Gutenberg University Hospital, Mainz, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Hink
authors.affiliation: Department of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Jeger
authors.affiliation: Department of Internal Medicine/Cardiology, University of Leipzig, Heart Centre, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Linke
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: E
authors.initials: E
authors.lastname: Deliargyris
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: P
authors.initials: P
authors.lastname: Gao
authors.affiliation: Icahn School of Medicine at Mount Sinai, The Zena and Michael a. Wiener Cardiovascular Institute, New York, New York.
authors.forename: R
authors.initials: R
authors.lastname: Mehran
authors.affiliation: DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany, and Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Hengstenberg
authors.affiliation: The Medicines Company, Zurich, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Anthopoulos
authors.affiliation: Icahn School of Medicine at Mount Sinai, The Zena and Michael a. Wiener Cardiovascular Institute, New York, New York.
authors.forename: G
authors.initials: G
authors.lastname: Dangas
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D005060:Europe; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000209:etiology; D009656:North America; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D012737:Sex Factors; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: bivalirudin or unfractionated heparin; early outcomes; sex-based differences; transcatheter aortic valve replacement