PMID- 34216757
OWN - NLM
STAT- Publisher
LR  - 20240222
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
DP  - 2021 May 26
TI  - Clinical Outcome Predictions for the VerICiguaT Global Study in Subjects With 
      Heart Failure With Reduced Ejection Fraction (VICTORIA) Trial: VICTORIA Outcomes 
      Model.
LID - S1071-9164(21)00206-2 [pii]
LID - 10.1016/j.cardfail.2021.05.016 [doi]
AB  - BACKGROUND: Prediction of outcomes in patients with heart failure (HF) may inform 
      prognosis, clinical decisions regarding treatment selection, and new trial 
      planning. The VICTORIA trial included high-risk patients with HF and reduced 
      ejection fraction and a recent worsening HF event. The study participants had an 
      unusually high event rate despite usage of contemporary guideline-based 
      therapies. To provide generalizable predictive data for a broad population with a 
      recent worsening HF event, we focused on risk prognostication in the placebo 
      group. METHODS: Data from 2524 participants randomized to placebo with chronic HF 
      (New York Heart Association class [NYHA] II-IV) and ejection fraction <45% were 
      studied and backward variable selection was used to create Cox proportional 
      hazards models for clinical endpoints, selecting from 66 candidate predictors. 
      Final model results were produced, accounting for missing data, non-linearities, 
      and interactions with treatment. Optimism-corrected c-indices were calculated 
      using 200 bootstrap samples. RESULTS: During a median follow-up of 10.4 months, 
      the primary outcome of HF hospitalization or cardiovascular death occurred in 972 
      (38.5%) patients. Independent predictors of increased risk for the primary 
      endpoint included HF characteristics (longer HF duration and worse NYHA class), 
      medical history (prior myocardial infarction), and laboratory values (higher 
      N-terminal pro-hormone B-type natriuretic peptide, bilirubin, urate; lower 
      chloride and albumin). Optimism-corrected c-indices were 0.68 for the HF 
      hospitalization/cardiovascular death model, 0.68 for HF hospitalization/all-cause 
      death, 0.72 for cardiovascular death, and 0.73 for all-cause death. CONCLUSIONS: 
      Predictive models developed in a large diverse clinical trial with comprehensive 
      clinical and laboratory baseline data-including novel measures-performed well in 
      high-risk HF patients who were receiving excellent guideline-based clinical care. 
      CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier, NCT02861534. LAY 
      SUMMARY: Patients with heart failure may benefit from tools that help clinicians 
      better understand patient's risk for future events like hospitalization. 
      Relatively few risk models have been created after worsening of heart failure in 
      a contemporary cohort. We provide insights on risk factors for clinical events 
      from a recent large, global trial of patients with worsening heart failure to 
      help clinicians better understand and communicate prognosis and select treatment 
      options.
CI  - Copyright (c) 2021. Published by Elsevier Inc.
FAU - Mentz, Robert J
AU  - Mentz RJ
AD  - Duke Clinical Research Institute, Duke University, Durham, NC. Electronic 
      address: robert.mentz@duke.edu.
FAU - Mulder, Hillary
AU  - Mulder H
AD  - Duke Clinical Research Institute, Duke University, Durham, NC.
FAU - Mosterd, Arend
AU  - Mosterd A
AD  - Meander Medical Center, Amersfoort, the Netherlands.
FAU - Sweitzer, Nancy K
AU  - Sweitzer NK
AD  - University of Arizona, Sarver Heart Center, Tucson, AZ.
FAU - Senni, Michele
AU  - Senni M
AD  - ASST Papa Giovanni XXIII Bergamo, Bergamo, Italy.
FAU - Butler, Javed
AU  - Butler J
AD  - The University of Mississippi Medical Center, Jackson, MS.
FAU - Ezekowitz, Justin A
AU  - Ezekowitz JA
AD  - University of Alberta, Canadian VIGOUR Centre, Edmonton, Canada.
FAU - Lam, Carolyn S P
AU  - Lam CSP
AD  - National Heart Centre Singapore, Duke-National University of Singapore, 
      Singapore.
FAU - Pieske, Burkert
AU  - Pieske B
AD  - Charite - Campus Virchow-Klinikum (CVK), German Heart Center, Berlin, Germany.
FAU - Ponikowski, Piotr
AU  - Ponikowski P
AD  - The Cardiology Department, Wroclaw Medical University, Wroclaw, Poland.
FAU - Voors, Adriaan A
AU  - Voors AA
AD  - University of Groningen, Groningen, the Netherlands.
FAU - Anstrom, Kevin J
AU  - Anstrom KJ
AD  - Duke Clinical Research Institute, Duke University, Durham, NC.
FAU - Armstrong, Paul W
AU  - Armstrong PW
AD  - University of Alberta, Canadian VIGOUR Centre, Edmonton, Canada.
FAU - O'Connor, Christopher M
AU  - O'Connor CM
AD  - Inova Heart and Vascular Institute, Falls Church, VA.
CN  - VICTORIA Study Group
AD  - Duke Clinical Research Institute, Duke University, Durham, NC.
LA  - eng
SI  - ClinicalTrials.gov/NCT02861534
PT  - Journal Article
DEP - 20210526
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
SB  - IM
OTO - NOTNLM
OT  - heart failure with reduced ejection fraction
OT  - outcomes
OT  - predictive models
OT  - prognosis
EDAT- 2021/07/04 06:00
MHDA- 2021/07/04 06:00
CRDT- 2021/07/03 20:12
PHST- 2021/02/11 00:00 [received]
PHST- 2021/05/03 00:00 [revised]
PHST- 2021/05/04 00:00 [accepted]
PHST- 2021/07/03 20:12 [entrez]
PHST- 2021/07/04 06:00 [pubmed]
PHST- 2021/07/04 06:00 [medline]
AID - S1071-9164(21)00206-2 [pii]
AID - 10.1016/j.cardfail.2021.05.016 [doi]
PST - aheadofprint
SO  - J Card Fail. 2021 May 26:S1071-9164(21)00206-2. doi: 
      10.1016/j.cardfail.2021.05.016.