Bayer has shared new data from the VICTOR Phase III vericiguat heart failure trial in patients with HFrEF who have not had a recent heart failure event. The results were presented at the ESC Congress 2025 and published in The Lancet, adding important context to the evidence base for vericiguat (Verquvo™).
VICTOR Phase III vericiguat heart failure: primary and secondary outcomes
In VICTOR, vericiguat added to guideline-directed medical therapy (GDMT) did not reach statistical significance for the primary composite endpoint of cardiovascular death or heart failure hospitalisation compared with placebo on top of GDMT. The study enrolled a very well-treated HFrEF population: the majority of participants received multiple background therapies and nearly half had no prior hospitalisation for heart failure.
Notably, secondary endpoints suggested fewer events of cardiovascular death and all-cause mortality in the vericiguat group versus placebo. While these findings are descriptive and the primary endpoint was not met, they provide clinically relevant insight into outcomes for a stable, well-managed HFrEF cohort.
Pooled analysis with VICTORIA strengthens the evidence base
A pre-specified pooled analysis across VICTORIA and VICTOR (11,155 patients) showed a statistically significant reduction in the composite of cardiovascular death or heart failure hospitalisation, and in its individual components, with vericiguat. This analysis supports the therapy’s role across a broad spectrum of patients with HFrEF.
Approved indication unchanged
The positive benefit–risk profile of vericiguat in its approved indication—patients with HFrEF following a recent heart failure event—remains unchanged based on the pivotal Phase III VICTORIA trial. VICTOR adds context for a stable HFrEF population without a recent event and underscores the importance of patient selection when considering therapy.
