PMID- 37036268
OWN - NLM
STAT- MEDLINE
DCOM- 20230511
LR  - 20230511
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Linking)
VI  - 101
IP  - 6
DP  - 2023 May
TI  - Impact of coronary artery disease on clinical outcomes after TAVR: Insights from 
      the BRAVO-3 randomized trial.
PG  - 1134-1143
LID - 10.1002/ccd.30647 [doi]
AB  - OBJECTIVE: To determine the prognostic impact of coronary artery disease (CAD) in 
      patients randomized to bivalirudin or unfractionated heparin (UFH) during 
      transcatheter aortic valve replacement (TAVR). BACKGROUND: CAD is a common 
      comorbidity among patients undergoing TAVR and studies provide conflicting data 
      on its prognostic impact. METHODS: The Bivalirudin on Aortic Valve Intervention 
      Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH 
      in 802 high-surgical risk patients undergoing transfemoral TAVR for severe 
      symptomatic aortic stenosis. Patients were stratified according to the presence 
      or absence of history of CAD as well as periprocedural anticoagulation. The 
      coprimary endpoints were net adverse cardiac events (NACE; a composite of 
      all-cause mortality, myocardial infarction, stroke, or major bleeding) and major 
      Bleeding Academic Research Consortium (BARC) bleeding >/=3b at 30 days 
      postprocedure. RESULTS: Among 801 patients, 437 (54.6%) had history of CAD of 
      whom 223 (51.0%) received bivalirudin. There were no significant differences in 
      NACE (adjusted odds ratio [OR]: 1.04; 95% confidence interval [CI]: 0.69-1.58) or 
      BARC >/= 3b bleeding (adjusted OR: 0.84; 95% CI: 0.51-1.39) in patients with vs 
      without CAD at 30 days. Among CAD patients, periprocedural use of bivalirudin was 
      associated with similar NACE (OR: 0.80; 95% CI: 0.47-1.35) and BARC >/= 3b bleeding 
      (OR: 0.64; 95% CI: 0.33-1.25) compared with UFH, irrespective of history of CAD 
      (p-interaction = 0.959 for NACE; p-interaction = 0.479 for major bleeding). 
      CONCLUSION: CAD was not associated with a higher short-term risk of NACE or major 
      bleeding after TAVR. Periprocedural anticoagulation with bivalirudin did not show 
      any advantage over UFH in patients with and without CAD.
CI  - (c) 2023 Wiley Periodicals LLC.
FAU - Feldman, Daniel
AU  - Feldman D
AUID- ORCID: 0000-0002-9249-3468
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
AD  - Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New 
      York, USA.
FAU - Cao, Davide
AU  - Cao D
AUID- ORCID: 0000-0001-7755-4069
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
AD  - Department of Biomedical Sciences, Humanitas University, Milan, Italy.
FAU - Sartori, Samantha
AU  - Sartori S
AUID- ORCID: 0000-0003-0618-9409
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
FAU - Zhang, Zhongjie
AU  - Zhang Z
AUID- ORCID: 0000-0002-9615-0518
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
FAU - Hengstenberg, Christian
AU  - Hengstenberg C
AD  - Department of Internal Medicine II, Division of Cardiology, Medical University of 
      Vienna, Vienna, Austria.
FAU - Tron, Christophe
AU  - Tron C
AD  - Division of Cardiology, Rouen University Hospital, Rouen, France.
FAU - Anthopoulos, Prodromos
AU  - Anthopoulos P
AD  - European Medical, Arena Pharmaceuticals Inc, Zurich, Switzerland.
FAU - Widder, Julian D
AU  - Widder JD
AD  - Department of Medicine, Cardiology and Angiology, Municipial Hospital Karlsruhe, 
      Karlsruhe, Germany.
FAU - Meneveau, Nicolas
AU  - Meneveau N
AD  - Department of Cardiology, University Hospital Jean Minjoz, Besancon, France.
FAU - Stella, Pieter R
AU  - Stella PR
AD  - Department of Cardiology, University Medical Center Utrecht, Utrecht, the 
      Netherlands.
FAU - Ferrari, Markus
AU  - Ferrari M
AD  - Division of Interventional Cardiology, Helios Dr. Horst Schmidt Kliniken 
      Wiesbaden, Wiesbaden, Germany.
FAU - Jeger, Raban
AU  - Jeger R
AD  - Department of Cardiology, Triemli Hospital, Zurich, Switzerland.
AD  - Department of Cardiology, University Hospital Basel, Basel, Switzerland.
FAU - Violini, Roberto
AU  - Violini R
AD  - Department of Interventional Cardiology, Azienda Ospedaliera S.Camillo Forlanini, 
      Rome, Italy.
FAU - Dumonteil, Nicolas
AU  - Dumonteil N
AD  - Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
FAU - Chen, Shiwei
AU  - Chen S
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
FAU - Yan, Ruiqi
AU  - Yan R
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
FAU - Nicolas, Johny
AU  - Nicolas J
AUID- ORCID: 0000-0002-3015-3361
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
FAU - Razuk, Victor
AU  - Razuk V
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
AD  - Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New 
      York, USA.
FAU - Spirito, Alessandro
AU  - Spirito A
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
FAU - Vogel, Birgit
AU  - Vogel B
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, New York, USA.
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, USA.
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, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230410
PL  - United States
TA  - Catheter Cardiovasc Interv
JT  - Catheterization and cardiovascular interventions : official journal of the 
      Society for Cardiac Angiography & Interventions
JID - 100884139
RN  - 9005-49-6 (Heparin)
RN  - 0 (Antithrombins)
RN  - J718M71A7A (tetrachloroisophthalonitrile)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Humans
MH  - Heparin/adverse effects
MH  - *Coronary Artery Disease/complications/diagnostic imaging/therapy
MH  - *Transcatheter Aortic Valve Replacement/adverse effects
MH  - Antithrombins/adverse effects
MH  - Treatment Outcome
MH  - Hirudins/adverse effects
MH  - Hemorrhage/chemically induced
MH  - Peptide Fragments/adverse effects
MH  - Recombinant Proteins/adverse effects
OTO - NOTNLM
OT  - TAVR
OT  - aortic stenosis
OT  - coronary artery disease
OT  - outcomes
EDAT- 2023/04/11 06:00
MHDA- 2023/05/11 06:42
CRDT- 2023/04/10 09:22
PHST- 2023/02/15 00:00 [revised]
PHST- 2022/11/18 00:00 [received]
PHST- 2023/03/08 00:00 [accepted]
PHST- 2023/05/11 06:42 [medline]
PHST- 2023/04/11 06:00 [pubmed]
PHST- 2023/04/10 09:22 [entrez]
AID - 10.1002/ccd.30647 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2023 May;101(6):1134-1143. doi: 10.1002/ccd.30647. 
      Epub 2023 Apr 10.