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Clinical outcomes after TAVR with heparin or bivalirudin as periprocedural anticoagulation in patients with and without peripheral arterial disease: Results from the BRAVO-3 randomized trial.

  • Zilberszac, Robert1
  • Chandiramani, Rishi2
  • Hengstenberg, Christian1
  • Sartori, Samantha2
  • Cao, Davide2
  • Chandrasekhar, Jaya2
  • Schafer, Ulrich3, 4
  • Tchetche, Didier5
  • Violini, Roberto6
  • Jeger, Raban7
  • Van Belle, Eric8
  • Boekstegers, Peter9
  • Hambrecht, Rainer10
  • Tron, Christophe11
  • Dumenteil, Nicolas5
  • Linke, Axel12
  • Ten Berg, Jurriën M13
  • Deliargyris, Efthymios N14
  • Anthopoulos, Prodromos15
  • Mehran, Roxana2
  • And 1 more
  • 1 Department of Cardiology, Medical University of Vienna, Vienna, Austria. , (Austria)
  • 2 The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
  • 3 Department of Cardiology, University Heart Center, Hamburg, Germany. , (Germany)
  • 4 Department of Cardiology, Asklepios Clinics St. Georg, Hamburg, Germany. , (Germany)
  • 5 Department of General and Interventional Cardiology, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France. , (France)
  • 6 Interventional Cardiology Unit, San Camillo Hospital, Rome, Italy. , (Italy)
  • 7 Department of Cardiology, University Hospital Basel, University of Basel, Switzerland. , (Switzerland)
  • 8 Department of Cardiology and INSERM UMR 1011, University Hospital and CHRU Lille, Lille, France. , (France)
  • 9 Department of Cardiology, Helios Heart Center Siegburg, Siegburg, Germany. , (Germany)
  • 10 Department of Cardiology, Klinikum Links der Weser, Bremen, Germany. , (Germany)
  • 11 Department of Cardiology, Rouen University Hospital, Rouen, France. , (France)
  • 12 Department of Cardiology, Universität Leipzig, Herzzentrum, Leipzig, Germany. , (Germany)
  • 13 Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands. , (Netherlands)
  • 14 PLx Pharma Inc., Sparta, New Jersey. , (Jersey)
  • 15 Division of Cardiology, The Medicines Company, Zurich, Switzerland. , (Switzerland)
Published Article
Catheterization and Cardiovascular Interventions
Wiley (John Wiley & Sons)
Publication Date
Sep 01, 2020
DOI: 10.1002/ccd.28642
PMID: 31808295


This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO-3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH). PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH. BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE. The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in-hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days. Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications. © 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.

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