PMID- 33839885
OWN - NLM
STAT- MEDLINE
DCOM- 20211119
LR  - 20211119
IS  - 1861-0692 (Electronic)
IS  - 1861-0684 (Linking)
VI  - 110
IP  - 5
DP  - 2021 May
TI  - Incidence, predictors, and outcomes associated with acute kidney injury in 
      patients undergoing transcatheter aortic valve replacement: from the BRAVO-3 
      randomized trial.
PG  - 649-657
LID - 10.1007/s00392-020-01787-7 [doi]
AB  - BACKGROUND: Acute kidney injury (AKI) is not uncommon in patients undergoing 
      transcatheter aortic valve replacement (TAVR). OBJECTIVE: We examined the 
      incidence, predictors, and outcomes of AKI from the BRAVO 3 randomized trial. 
      METHODS: The BRAVO-3 trial included 802 patients undergoing transfemoral TAVR 
      randomized to bivalirudin vs. unfractionated heparin (UFH). The primary endpoint 
      of the trial was Bleeding Academic Research Consortium (BARC) type >/= 3b bleeding 
      at 48 h. Total follow-up was to 30 days. AKI was adjudicated using the modified 
      RIFLE (Valve Academic Research Consortium, VARC 1) criteria through 30-day 
      follow-up, and in a sensitivity analysis AKI was assessed at 7 days (modified 
      VARC-2 criteria). We examined the incidence, predictors, and 30-day outcomes 
      associated with diagnosis of AKI. We also examined the effect of procedural 
      anticoagulant (bivalirudin or unfractionated heparin, UFH) on AKI within 
      48 h after TAVR. RESULTS: The trial population had a mean age of 82.3 +/- 6.5 years 
      including 48.8% women with mean EuroScore I 17.05 +/- 10.3%. AKI occurred in 17.0% 
      during 30-day follow-up and was associated with greater adjusted risk of 30-day 
      death (13.0% vs. 3.5%, OR 5.84, 95% CI 2.62-12.99) and a trend for more BARC >/= 3b 
      bleeding (15.1% vs. 8.6%, OR 1.80, 95% CI 0.99-3.25). Predictors of 30-day AKI 
      were baseline hemoglobin, body weight, and pre-existing coronary disease. AKI 
      occurred in 10.7% at 7 days and was associated with significantly greater risk of 
      30-day death (OR 6.99, 95% CI 2.85-17.15). Independent predictors of AKI within 
      7 days included pre-existing coronary or cerebrovascular disease, chronic kidney 
      disease (CKD), and transfusion which increased risk, whereas post-dilation was 
      protective. The incidence of 48-h AKI was higher with bivalirudin compared to UFH 
      in the intention to treat cohort (10.9% vs. 6.5%, p = 0.03), but not in the 
      per-protocol assessment (10.7% vs. 7.1%, p = 0.08). CONCLUSION: In the BRAVO 3 
      trial, AKI occurred in 17% at 30 days and in 10.7% at 7 days. AKI was associated 
      with a significantly greater adjusted risk for 30-day death. Multivariate 
      predictors of AKI at 30 days included baseline hemoglobin, body weight, and prior 
      coronary artery disease, and predictors at 7 days included pre-existing vascular 
      disease, CKD, transfusion, and valve post-dilation. Bivalirudin was associated 
      with greater AKI within 48 h in the intention to treat but not in the 
      per-protocol analysis.
FAU - Chandrasekhar, Jaya
AU  - Chandrasekhar J
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, USA.
AD  - Department of Cardiology, Box Hill Hospital, Eastern Health Clinical School, 
      Monash University, Melbourne, Australia.
FAU - Sartori, Samantha
AU  - Sartori S
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, USA.
FAU - Mehran, Roxana
AU  - Mehran R
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, USA.
AD  - Mount Sinai Medical Center, One Gustave L. Levy Place, Box 1030, New York, NY, 
      10029, USA.
FAU - Aquino, Melissa
AU  - Aquino M
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, 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, USA.
FAU - Asgar, Anita W
AU  - Asgar AW
AD  - Institut de Cardiologie de Montreal, Montreal, Canada.
FAU - Webb, John G
AU  - Webb JG
AD  - St. Paul's Hospital, Vancouver, Canada.
FAU - Tchetche, Didier
AU  - Tchetche D
AD  - Clinic Pasteur of Toulouse, Toulouse, France.
FAU - Dumonteil, Nicolas
AU  - Dumonteil N
AD  - Clinic Pasteur of Toulouse, Toulouse, France.
FAU - Colombo, Antonio
AU  - Colombo A
AD  - San Raffaele Hospital of Milan (IRCCS), Milan, Italy.
FAU - Windecker, Stephan
AU  - Windecker S
AD  - Bern University Hospital, Bern, Switzerland.
FAU - Claessen, Bimmer E
AU  - Claessen BE
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, USA.
FAU - Ten Berg, Jurrien M
AU  - Ten Berg JM
AD  - St. Antonius Ziekenhuis, Nieuwegein, Netherlands.
FAU - Hildick-Smith, David
AU  - Hildick-Smith D
AD  - Sussex Cardiac Centre, Brighton, UK.
FAU - Wijngaard, Peter
AU  - Wijngaard P
AD  - The Medicines Company, Zurich, Switzerland.
FAU - Lefevre, Thierry
AU  - Lefevre T
AD  - Hopital Prive Jacques Cartier, Massy, France.
FAU - Deliargyris, Efthymios N
AU  - Deliargyris EN
AD  - The Medicines Company, Parsippany, NJ, USA.
FAU - Hengstenberg, Christian
AU  - Hengstenberg C
AD  - Munich Heart Alliance, Munich, Germany.
FAU - Anthopoulos, Prodromos
AU  - Anthopoulos P
AD  - The Medicines Company, Zurich, Switzerland.
FAU - Dangas, George D
AU  - Dangas GD
AD  - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine 
      at Mount Sinai, New York, USA. gdangas@crf.org.
AD  - Mount Sinai Medical Center, One Gustave L. Levy Place, Box 1030, New York, NY, 
      10029, USA. gdangas@crf.org.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210411
PL  - Germany
TA  - Clin Res Cardiol
JT  - Clinical research in cardiology : official journal of the German Cardiac Society
JID - 101264123
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  - Acute Kidney Injury/*epidemiology/etiology
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/*administration & dosage/adverse effects
MH  - Antithrombins/administration & dosage/adverse effects
MH  - Female
MH  - Follow-Up Studies
MH  - Hemorrhage/chemically induced/epidemiology
MH  - Heparin/administration & dosage/adverse effects
MH  - Hirudins/administration & dosage/adverse effects
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Peptide Fragments/administration & dosage/adverse effects
MH  - Postoperative Complications/*epidemiology
MH  - Recombinant Proteins/administration & dosage/adverse effects
MH  - Time Factors
MH  - Transcatheter Aortic Valve Replacement/*methods
OTO - NOTNLM
OT  - 30-day outcomes
OT  - Acute kidney injury
OT  - Transcatheter aortic valve replacement
EDAT- 2021/04/12 06:00
MHDA- 2021/11/20 06:00
CRDT- 2021/04/11 20:52
PHST- 2019/11/17 00:00 [received]
PHST- 2020/11/24 00:00 [accepted]
PHST- 2021/04/12 06:00 [pubmed]
PHST- 2021/11/20 06:00 [medline]
PHST- 2021/04/11 20:52 [entrez]
AID - 10.1007/s00392-020-01787-7 [pii]
AID - 10.1007/s00392-020-01787-7 [doi]
PST - ppublish
SO  - Clin Res Cardiol. 2021 May;110(5):649-657. doi: 10.1007/s00392-020-01787-7. Epub 
      2021 Apr 11.