Proportion of guideline-directed drug and gadget remedy throughout up to date coronary heart failure with lowered ejection fraction trials. Credit score: European Journal of Coronary heart Failure (2025). DOI: 10.1002/ejhf.3598
Vericiguat didn’t scale back the danger of cardiovascular mortality and coronary heart failure (HF) hospitalizations in ambulatory sufferers with HF and lowered ejection fraction (HFrEF) with out latest worsening, in keeping with late-breaking analysis offered August 30 in a Scorching Line session at ESC Congress 2025. The analysis was revealed earlier this yr within the European Journal of Coronary heart Failure.
Vericiguat is an oral soluble guanylate cyclase stimulator that restores the impaired nitric oxide signaling that could be a hallmark of HFrEF. Vericiguat is authorised for the therapy of worsening HF, primarily based on a discount in cardiovascular demise or hospitalization within the VICTORIA trial revealed in 2020.
“Given the positive results from the VICTORIA trial in patients with a recent worsening event, we designed the VICTOR trial to evaluate vericiguat in HFrEF patients without recent worsening who received more contemporary background HF therapy,” commented Professor Faiez Zannad from the Université de Lorraine, Vandoeuvre-Les-Nancy, France.
VICTOR was a randomized, double-blind, placebo-controlled part III trial carried out at 616 facilities in 42 international locations. Members have been adults with left ventricular ejection fraction (LVEF) ≤40%, New York Coronary heart Affiliation (NYHA) class II−IV signs on optimally tolerated guideline-directed medical remedy and no latest hospitalization for HF inside six months or outpatient intravenous diuretic use inside three months.
N-terminal pro-B-type natriuretic peptide (NT-proBNP) ranges have been required to be 600–6,000 pg/ml for sufferers in sinus rhythm and 900–6,000 pg/ml for these in atrial fibrillation. Members with estimated glomerular filtration fee (eGFR) 2 have been excluded.
Members have been randomized 1:1 to vericiguat (beginning dose of two.5 mg titrated to a 10-mg goal dose) or to matching placebo. The first endpoint was a composite of cardiovascular demise or hospitalization for HF. The examine was powered for cardiovascular demise.
The 6,105 randomized sufferers had a imply age of 67 years and 23.6% have been feminine. In complete, 47.5% of sufferers had no prior hospitalization for HF and solely 14% had a historical past of hospitalization between 6 to 12 months previous to randomization. General, 79% of contributors had NYHA class II signs and the imply LVEF was 30%.
Over 18.5 months median follow-up, major end result occasion—cardiovascular demise or HF hospitalization—occurred in 18.0% of sufferers within the vericiguat group and 19.1% of sufferers within the placebo group (hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.83 to 1.04; p=0.22).
Cardiovascular demise occurred in 9.6% of sufferers within the vericiguat group and 11.3% of sufferers within the placebo group (HR 0.83; 95% CI 0.71 to 0.97), whereas hospitalization for HF occurred in 11.4% and 11.9% of sufferers, respectively (HR 0.95; 95% CI 0.82 to 1.10). All-cause demise occurred in 12.3% of sufferers with vericiguat and in 14.4% of sufferers with placebo (HR 0.84; 95% CI 0.74 to 0.97). The consequences of vericiguat have been constant throughout prespecified subgroups.
Severe adversarial occasions occurred in 23.5% and 24.6% of sufferers within the vericiguat and placebo teams, respectively.
Discussing the primary findings, Professor Zannad mentioned, “Though vericiguat didn’t enhance the first composite of cardiovascular demise or hospitalization for HF, there have been fewer cardiovascular deaths with vericiguat and this translated into fewer all-cause deaths.
“The risk of HF hospitalization was not reduced, which may be due, at least in part, to the high use of contemporary HF therapies and the low proportion of recent hospitalizations in this population. Overall, these findings support the use of vericiguat in ambulatory patients with HFrEF on top of contemporary therapies.”
Outcomes from a pooled evaluation of VICTORIA and VICTOR, throughout the vary of HF severity, have been offered in the identical Scorching Line session. Further outcomes from prespecified analyses on mortality and HF hospitalization from the VICTOR trial have been offered at ESC Congress 2025 on Monday, Sept. 1.
Extra info:
Clara I. Saldarriaga et al, Baseline traits of up to date trial contributors with coronary heart failure and lowered ejection fraction: The VICTOR trial, European Journal of Coronary heart Failure (2025). DOI: 10.1002/ejhf.3598
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European Society of Cardiology
Quotation:
Vericiguat didn’t meet major endpoint however lowered threat of cardiovascular demise in sufferers with coronary heart failure (2025, September 2)
retrieved 2 September 2025
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