PMID- 28498562
OWN - NLM
STAT- MEDLINE
DCOM- 20180717
LR  - 20180717
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Linking)
VI  - 90
IP  - 6
DP  - 2017 Nov 15
TI  - Effect of valve design and anticoagulation strategy on 30-day clinical outcomes 
      in transcatheter aortic valve replacement: Results from the BRAVO 3 randomized 
      trial.
PG  - 1016-1026
LID - 10.1002/ccd.27154 [doi]
AB  - BACKGROUND: 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-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] 
      type from the BRAVO-3 trial. METHODS: BRAVO-3 was a randomized multicenter trial 
      including 500 BE-TAVR and 282 non-BE 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 >/=3b 
      bleeding, major vascular complications and all ischemic outcomes at 30-days. 
      Outcomes were adjusted using logistic regression analysis. RESULTS: Of the trial 
      cohort, 63.9% were treated with BE valves (n = 251 bivalirudin vs. n = 249 UFH) 
      and 36.1% with non-BE valves (n = 140 bivalirudin vs. n = 142 UFH). Patients 
      treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there 
      were nonsignificant differences between the two valve types for adjusted risk of 
      all-cause death (HR 2.07, 95% CI 0.91-4.70, P = 0.084) and major vascular 
      complications (HR 1.78, 95% CI 0.97-3.26, P = 0.062) with non-BE 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-BE TAVR 
      (P-interaction = 0.039). CONCLUSIONS: Majority of patients in the BRAVO 3 trial 
      received BE valves. At 30-days, adjusted risk of clinical outcomes was similar 
      with non-BE 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-BE TAVR.
CI  - (c) 2017 Wiley Periodicals, Inc.
FAU - Linke, Axel
AU  - Linke A
AD  - Department of Internal Medicine/Cardiology, University of Leipzig, Heart Centre, 
      Germany.
FAU - Chandrasekhar, Jaya
AU  - Chandrasekhar J
AUID- ORCID: 0000-0001-8776-326X
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Sartori, Samantha
AU  - Sartori S
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Lefevre, Thierry
AU  - Lefevre T
AD  - Division of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Generale de 
      Sante, Massy, France.
FAU - van Belle, Eric
AU  - van Belle E
AD  - Department of Cardiology and INSERM UMR 1011, University Hospital, and CHRU 
      Lille, Lille, France.
FAU - Schaefer, Ulrich
AU  - Schaefer U
AD  - Division of Cardiologyy, University Heart Center, Hamburg, Germany.
AD  - Division of Cardiologyy, Asklepios Clinics St. Georg, Hamburg, Germany.
FAU - Tchetche, Didier
AU  - Tchetche D
AD  - Division of Cardiologyy, Clinique Pasteur Toulouse, France.
FAU - Sardella, Gennaro
AU  - Sardella G
AD  - Division of Cardiologyy, Policlinico Umberto I, Rome, Italy.
FAU - Webb, John
AU  - Webb J
AD  - Division of Cardiologyy, St. Paul's Hospital, Vancouver, British Columbia, 
      Canada.
FAU - Colombo, Antonio
AU  - Colombo A
AD  - Division of Cardiologyy, San Raffaele Hospital, Milan, Italy.
FAU - Windecker, Stephan
AU  - Windecker S
AD  - Department of Cardiology, Bern University Hospital, Switzerland.
FAU - Vogel, Birgit
AU  - Vogel B
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Farhan, Serdar
AU  - Farhan S
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Sorrentino, Sabato
AU  - Sorrentino S
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Sharma, Madhav
AU  - Sharma M
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Snyder, Clayton
AU  - Snyder C
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Asgar, Anita
AU  - Asgar A
AD  - Division of Cardiology, Montreal Heart Institute, Montreal, Canada.
FAU - Dumonteil, Nicolas
AU  - Dumonteil N
AD  - Division of Cardiologyy, Clinique Pasteur Toulouse, France.
FAU - Tamburino, Corrado
AU  - Tamburino C
AD  - Division of Cardiology, University of Catania, Italy.
FAU - Hink, Ulrich
AU  - Hink U
AD  - Cardiology Department, Johannes Gutenberg University Hospital, Mainz, Germany.
FAU - Violini, Roberto
AU  - Violini R
AD  - Division of Cardiology, Azienda Ospedaliera San Camillo-Forlanini di Roma, Italy.
FAU - Stella, Pieter
AU  - Stella P
AD  - Division of Cardiology, University Medical Center Utrecht, The Netherlands.
FAU - Bernstein, Debra
AU  - Bernstein D
AD  - Division of Cardiology, The Medicines Company, Parsippany, New Jersey.
FAU - Deliargyris, Efthymios
AU  - Deliargyris E
AD  - Division of Cardiology, The Medicines Company, Parsippany, New Jersey.
FAU - Hengstenberg, Christian
AU  - Hengstenberg C
AUID- ORCID: 0000-0002-8284-2994
AD  - Division of Cardiology, DZHK (German Centre for Cardiovascular Research), partner 
      site Munich Heart Alliance, Munich, Germany.
AD  - Division of Cardiologyy, Deutsches Herzzentrum Munchen, Technische Universitat 
      Munchen, Munich, Germany.
FAU - Baber, Usman
AU  - Baber U
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Mehran, Roxana
AU  - Mehran R
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
FAU - Anthopoulos, Prodromos
AU  - Anthopoulos P
AD  - Division of Cardiology, The Medicines Company, Zurich, Switzerland.
FAU - Dangas, George
AU  - Dangas G
AUID- ORCID: 0000-0001-7502-8049
AD  - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, 
      Icahn School of Medicine at Mount Sinai, New York.
CN  - BRAVO-3 Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170719
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 (Antithrombins)
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Aged, 80 and over
MH  - Antithrombins/administration & dosage
MH  - Aortic Valve/diagnostic imaging/surgery
MH  - Aortic Valve Stenosis/complications/diagnosis/*surgery
MH  - Cause of Death/trends
MH  - Dose-Response Relationship, Drug
MH  - Europe/epidemiology
MH  - Female
MH  - Fibrinolytic Agents/administration & dosage
MH  - Follow-Up Studies
MH  - Heart Valve Prosthesis
MH  - Heparin/*administration & dosage
MH  - Hirudins/*administration & dosage
MH  - Humans
MH  - Incidence
MH  - Infusions, Intravenous
MH  - Male
MH  - Peptide Fragments/*administration & dosage
MH  - *Practice Guidelines as Topic
MH  - Prosthesis Design
MH  - Recombinant Proteins/administration & dosage
MH  - Retrospective Studies
MH  - Survival Rate/trends
MH  - Thrombolytic Therapy/*methods
MH  - Thrombosis/epidemiology/etiology/*prevention & control
MH  - Time Factors
MH  - Transcatheter Aortic Valve Replacement/*standards
MH  - Treatment Outcome
MH  - United States/epidemiology
OTO - NOTNLM
OT  - balloon expandable versus non-balloon expandable valves
OT  - bivalirudin or unfractionated heparin
OT  - major vascular complications
OT  - transcatheter aortic valve replacement
EDAT- 2017/05/13 06:00
MHDA- 2018/07/18 06:00
CRDT- 2017/05/13 06:00
PHST- 2017/04/11 00:00 [received]
PHST- 2017/04/30 00:00 [accepted]
PHST- 2017/05/13 06:00 [pubmed]
PHST- 2018/07/18 06:00 [medline]
PHST- 2017/05/13 06:00 [entrez]
AID - 10.1002/ccd.27154 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2017 Nov 15;90(6):1016-1026. doi: 10.1002/ccd.27154. 
      Epub 2017 Jul 19.