Clinical Outcome Predictions for the VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) Trial
Section snippets
Patient Cohort and Trial Overview
The VICTORIA trial design, baseline characteristics, and outcomes have been previously reported elsewhere.5,7,8 Briefly, VICTORIA was a multicenter, international, randomized, placebo-controlled trial that investigated the efficacy and safety of the soluble guanylate cyclase stimulator, vericiguat, on a background of evidence-based medical and device therapy in 5050 patients with chronic HFrEF (New York Heart Association [NYHA] functional class II–IV) and a recent worsening HF event. Eligible
Results
Table 1 presents the baseline characteristics of the study population. The median age of participants was 68 years, 23.9% were female, and 64.1% were White. The majority of patients were in NYHA functional classification II (59.3%) or III (39.4%) at the time of randomization with a median N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) of 2821 pg/mL. Supplemental Table 2 presents the numbers missing for the different variables with most variables having less than 2% missing data.
Discussion
The VICTORIA model identifies key prognostic variables for the high-risk cohort of patients with HFrEF with recent clinical worsening. These variables include many of those that are routinely known or collected at the time of HF hospitalization or outpatient worsening. Specifically, the clinical characteristics with independent prognostic usefulness for the primary end point of HF hospitalization or cardiovascular death included HF characteristics (longer HF duration and worse NYHA functional
Conclusions
Predictive models developed in a large diverse clinical trial with extensive clinical and laboratory data—including novel measures—performed well in high-risk patients with HF who were receiving excellent guideline-based clinical care. These models refining patient prognosis may further guide clinical decision-making and future clinical trial design.
Disclosures
The VICTORIA trial was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Bayer.
Dr Mentz reports research support and honoraria from Bayer and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Hillary Mulder has nothing to report. Dr Mosterd has nothing to report. Dr Sweitzer reports consulting fees from Merck. Dr. Senni has nothing to report. Dr Butler reports consulting fees from Bayer, Merck, Amgen, AstraZeneca,
Funding
The VICTORIA trial was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and Bayer AG, Wuppertal, Germany.
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