Effect of Vericiguat on Heart Failure Hospitalization Events in Ambulatory Patients With HFrEF: VICTOR Trial Prespecified Analysis

Dr. Butler:
Hello from Heart Failure Society of America 2025 here in Minneapolis. I am Dr. Javed Butler, and today I will be reviewing data from a prespecified analysis of the VICTOR trial regarding the effects of vericiguat on heart failure hospitalization events in patients with heart failure and reduced ejection fraction.

By way of background, vericiguat, a soluble guanylate cyclase stimulator, was assessed in a trial previously in patients with worsening heart failure. And in that trial showed us that in those patients with heart failure and reduced ejection fraction who had recent worsening event, either a hospitalization within the past 6 months or outpatient IV diuretic within the past 3 months, those patients had a significant reduction in cardiovascular mortality or heart failure hospitalization.

And on the basis of those results, the drug was approved and was available for clinical use. However, we also wanted to get the data on the rest of the patient population that was not studied in the VICTORIA trial, and that led to the VICTOR trial.

VICTOR trial had patients with heart failure and reduced ejection fraction who did not have a recent worsening heart failure event. In other words, they were not hospitalized within the past 6 months or required outpatient IV diuretics within the past 3 months. Over 6,000 patients were studied.

What we did find in this study was a pretty remarkable result that cardiovascular mortality and all-cause mortality was reduced, but heart failure hospitalizations were not reduced. Now we have not seen this in a heart failure trial previously, so that was interesting. So we dug a little bit deeper into this to try to understand these results.  

So the first thing that we understood was that if you look at the baseline medical therapy—remember, we have never done a trial like this, but the baseline therapy is so good, 80% of the patients have NYHA Class II and 85% of the patients have never been hospitalized or had hospitalization really in the remote past.  

So what we found was that baseline medical therapy was related to those patients who were on quadruple therapy. They did not benefit as much as if the patients were not on very good background medical therapy. So that would make sense. But then here at the HFSA, we also did analysis based on recency of previous hospitalizations.

And what we found is that if you look at those patients that are hospitalization between 6 to 12 months, greater than 12 months, and those that were never hospitalized, those that had hospitalization, the 15% between 6 and 12 months, there was actually a significant benefit, numerically speaking, in terms of cardiovascular death, heart failure hospitalization.

So again, a little bit closer to the worsening we were seeing benefit. But interestingly, there was no difference in terms of the mortality benefit, which was seen across the spectrum. So these are really interesting results if you couple them by the fact that while the heart failure hospitalizations were not reduced, the outpatient worsening heart failure requiring changes in diuretic therapy was statistically significantly reduced.

Soa lot more to learn. But in summary, the overall worsening heart failure events were reduced, but the heart failure hospitalizations were not, and the mortality benefit was seen consistently. 

So from the Heart Failure Society of America 2025, I am Dr. Javed Butler, and thank you for listening.