PMID- 31808295
OWN - NLM
STAT- MEDLINE
DCOM- 20210405
LR  - 20210405
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Print)
IS  - 1522-1946 (Linking)
VI  - 96
IP  - 3
DP  - 2020 Sep 1
TI  - 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.
PG  - E377-E386
LID - 10.1002/ccd.28642 [doi]
AB  - OBJECTIVES: 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). 
      BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
CI  - (c) 2019 The Authors. Catheterization and Cardiovascular Interventions published by 
      Wiley Periodicals, Inc.
FAU - Zilberszac, Robert
AU  - Zilberszac R
AUID- ORCID: 0000-0002-8226-6149
AD  - Department of Cardiology, Medical University of Vienna, Vienna, Austria.
FAU - Chandiramani, Rishi
AU  - Chandiramani R
AUID- ORCID: 0000-0001-8659-6850
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York.
FAU - Hengstenberg, Christian
AU  - Hengstenberg C
AD  - Department of Cardiology, Medical University of Vienna, Vienna, Austria.
FAU - Sartori, Samantha
AU  - Sartori S
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York.
FAU - Cao, Davide
AU  - Cao D
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York.
FAU - Chandrasekhar, Jaya
AU  - Chandrasekhar J
AUID- ORCID: 0000-0001-8776-326X
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York.
FAU - Schafer, Ulrich
AU  - Schafer U
AUID- ORCID: 0000-0002-9684-320X
AD  - Department of Cardiology, University Heart Center, Hamburg, Germany.
AD  - Department of Cardiology, Asklepios Clinics St. Georg, Hamburg, Germany.
FAU - Tchetche, Didier
AU  - Tchetche D
AD  - Department of General and Interventional Cardiology, Groupe CardioVasculaire 
      Interventionnel, Clinique Pasteur, Toulouse, France.
FAU - Violini, Roberto
AU  - Violini R
AD  - Interventional Cardiology Unit, San Camillo Hospital, Rome, Italy.
FAU - Jeger, Raban
AU  - Jeger R
AD  - Department of Cardiology, University Hospital Basel, University of Basel, 
      Switzerland.
FAU - Van Belle, Eric
AU  - Van Belle E
AD  - Department of Cardiology and INSERM UMR 1011, University Hospital and CHRU Lille, 
      Lille, France.
FAU - Boekstegers, Peter
AU  - Boekstegers P
AD  - Department of Cardiology, Helios Heart Center Siegburg, Siegburg, Germany.
FAU - Hambrecht, Rainer
AU  - Hambrecht R
AD  - Department of Cardiology, Klinikum Links der Weser, Bremen, Germany.
FAU - Tron, Christophe
AU  - Tron C
AD  - Department of Cardiology, Rouen University Hospital, Rouen, France.
FAU - Dumenteil, Nicolas
AU  - Dumenteil N
AD  - Department of General and Interventional Cardiology, Groupe CardioVasculaire 
      Interventionnel, Clinique Pasteur, Toulouse, France.
FAU - Linke, Axel
AU  - Linke A
AD  - Department of Cardiology, Universitat Leipzig, Herzzentrum, Leipzig, Germany.
FAU - Ten Berg, Jurrien M
AU  - Ten Berg JM
AD  - Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands.
FAU - Deliargyris, Efthymios N
AU  - Deliargyris EN
AD  - PLx Pharma Inc., Sparta, New Jersey.
FAU - Anthopoulos, Prodromos
AU  - Anthopoulos P
AD  - Division of Cardiology, The Medicines Company, Zurich, Switzerland.
FAU - Mehran, Roxana
AU  - Mehran R
AUID- ORCID: 0000-0002-5546-262X
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York.
FAU - Dangas, George
AU  - Dangas G
AUID- ORCID: 0000-0001-7502-8049
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20191205
PL  - United States
TA  - Catheter Cardiovasc Interv
JT  - Catheterization and cardiovascular interventions : official journal of the 
      Society for Cardiac Angiography & Interventions
JID - 100884139
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Antithrombins/adverse effects/*therapeutic use
MH  - Aortic Valve Stenosis/complications/diagnosis/mortality/*surgery
MH  - *Catheterization, Peripheral/adverse effects/mortality
MH  - Cerebrovascular Disorders/etiology/mortality
MH  - Europe
MH  - Female
MH  - *Femoral Artery
MH  - Hemorrhage/chemically induced/mortality
MH  - Heparin/adverse effects/*therapeutic use
MH  - Hirudins/adverse effects
MH  - Hospital Mortality
MH  - Humans
MH  - Male
MH  - Myocardial Infarction/etiology/mortality
MH  - North America
MH  - Peptide Fragments/adverse effects/*therapeutic use
MH  - Peripheral Arterial Disease/*complications/diagnosis/mortality
MH  - Punctures
MH  - Randomized Controlled Trials as Topic
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - *Transcatheter Aortic Valve Replacement/adverse effects/mortality
MH  - Treatment Outcome
PMC - PMC7540270
OTO - NOTNLM
OT  - TAVR
OT  - bivalirudin
OT  - heparin
OT  - peripheral artery disease
EDAT- 2019/12/07 06:00
MHDA- 2021/04/07 06:00
PMCR- 2020/10/07
CRDT- 2019/12/07 06:00
PHST- 2019/06/28 00:00 [received]
PHST- 2019/09/18 00:00 [revised]
PHST- 2019/11/21 00:00 [accepted]
PHST- 2019/12/07 06:00 [pubmed]
PHST- 2021/04/07 06:00 [medline]
PHST- 2019/12/07 06:00 [entrez]
PHST- 2020/10/07 00:00 [pmc-release]
AID - CCD28642 [pii]
AID - 10.1002/ccd.28642 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2020 Sep 1;96(3):E377-E386. doi: 10.1002/ccd.28642. 
      Epub 2019 Dec 5.