Heart failure with reduced ejection fraction (HFrEF) occurs when the left ventricle of the heart is unable to pump out blood effectively. Despite current treatment strategies, there continues to be a high risk of adverse outcomes for HFrEF patients, particularly those who have had a worsening heart failure (HF) event.
The VICTORIA trial demonstrated that the drug vericiguat reduced the risk of cardiovascular death or HF hospitalization in patients with worsening HFrEF. In a recent secondary analysis of the trial published in JACC: Heart Failure, researchers sought to characterize the treatment benefit of vericiguat in this unique patient population by examining the link between vericiguat and recurrent hospitalizations, as well as mortality following HF hospitalization.
Utilizing the Andersen-Gill method, a model evaluating time to recurrent events, the researchers examined the total HF hospitalizations and cardiovascular death based on treatment group (vericiguat or placebo). The analysis also factored in the levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP, a protein produced by the heart and blood vessels) at the beginning of the trial to account for a varied treatment effect across the four prespecified ranges of NT-proBNP.
Among the 2,526 patients in the vericiguat treatment group, there were a total of 1,222 HF hospitalizations and cardiovascular deaths, and among the 2,524 patients in the placebo group there were 1,336 total events. While there was a slight indication of a benefit with vericiguat, study findings conclude there was no statistically significant reduction in either HF hospitalization or cardiovascular death. In view of the fact that rates of mortality remain high after HF hospitalization, the researchers emphasize the importance of identifying additional medical therapies that can improve outcomes for high-risk patients with HF.
“We continue to learn from the rich data set acquired in the VICTORIA study,” says Dr. Paul W. Armstrong, co-author and VICTORIA Study Chair. “Remarkably in this ancillary evaluation, nearly one-third of surviving patients had a repeat hospitalization during follow up: their mortality was more than twice that of the overall population despite good concomitant guideline based therapy. This gives us more incentive to be creative in planning for future studies to address the unmet needs for this high risk population.”
This research, conducted on behalf of the VICTORIA study group, was led by Robert Mentz, MD from the Duke Clinical Research Institute. CVC authors include Paul W. Armstrong, MD and Justin Ezekowitz, MBBCh, MSc.
