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Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction
Paul W Armstrong1, Burkert Pieske1, Kevin J Anstrom1
1From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).
Insights
Vericiguat significantly reduced the risk of cardiovascular death or heart failure hospitalization in high-risk patients. This novel soluble guanylate cyclase stimulator offers a new treatment option for chronic heart failure.
Area of Science:
- Cardiology
- Pharmacology
Background:
- The efficacy of vericiguat, an oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction (HFrEF) who have recently been hospitalized or received intravenous diuretics was previously unclear.
- High-risk HFrEF patients often experience recurrent hospitalizations and mortality, necessitating novel therapeutic strategies.
Purpose of the Study:
- To evaluate the effect of vericiguat, in addition to guideline-based medical therapy, on the composite outcome of cardiovascular death or heart failure hospitalization in high-risk HFrEF patients.
- To assess the safety and tolerability of vericiguat in this patient population.
Main Methods:
- A Phase 3, randomized, double-blind, placebo-controlled trial (VICTORIA) involving 5050 patients with chronic heart failure (NYHA class II-IV) and ejection fraction <45%.
- Patients received either vericiguat (10 mg once daily) or placebo, alongside standard medical therapy.
- The primary endpoint was the composite of death from cardiovascular causes or first hospitalization for heart failure.
Main Results:
- The primary outcome event occurred in 35.5% of patients receiving vericiguat versus 38.5% receiving placebo (hazard ratio [HR], 0.90; 95% CI, 0.82 to 0.98; P=0.02).
- Hospitalization for heart failure occurred in 27.4% of the vericiguat group and 29.6% of the placebo group (HR, 0.90; 95% CI, 0.81 to 1.00).
- Rates of symptomatic hypotension and syncope were similar between the vericiguat and placebo groups.
Conclusions:
- Vericiguat significantly reduced the composite incidence of cardiovascular death or heart failure hospitalization in high-risk patients with chronic heart failure.
- The findings support vericiguat as a valuable therapeutic option for select HFrEF patients, improving outcomes beyond guideline-based therapy.
Background:
The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.
Methods:
In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.
Results:
Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P = 0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P = 0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P = 0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P = 0.30).
Conclusions:
Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo. (Funded by Merck Sharp & Dohme [a subsidiary of Merck] and Bayer; VICTORIA ClinicalTrials.gov number, NCT02861534.).
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