ESC

ECS 2025: Vericiguat falls short on primary endpoint but cuts CV death risk in HFrEF

September 3, 2025

The phase 3 VICTOR trial evaluated vericiguat in 6,105 ambulatory patients with heart failure and reduced ejection fraction (HFrEF) who had no recent worsening events and were receiving guideline-directed medical therapy. Over a median follow-up of 18.5 months, vericiguat didn't meet its primary endpoint—a composite of cardiovascular death or heart failure hospitalization (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.83–1.04; p=0.22).

However, key secondary outcomes showed promise: vericiguat significantly reduced cardiovascular death (9.6% vs. 11.3%; HR, 0.83; 95% CI, 0.71–0.97) and all-cause mortality (12.3% vs. 14.4%; HR, 0.84; 95% CI, 0.74–0.97) compared with placebo. No significant reduction was observed in HF hospitalizations (HR, 0.95; 95% CI, 0.82–1.10).

The findings suggest that vericiguat may offer mortality benefits in stable HFrEF patients, despite the lack of impact on hospitalization rates. A pooled analysis with the VICTORIA trial, also presented at ESC Congress 2025, confirmed consistent reductions in CV death and HF hospitalization across a broader spectrum of HFrEF severity.

Source:

(2025, August 30). European Society of Cardiology. Vericiguat did not meet its primary endpoint but lowered the risk of cardiovascular death in patients with heart failure. [Press release]. https://www.escardio.org/The-ESC/Press-Office/Press-releases/Vericiguat-did-not-meet-its-primary-endpoint-but-lowered-the-risk-of-cardiovascular-death-in-patients-with-heart-failure#