The VICTORIA trial: Transcatheter aortic-valve replacement versus surgery [Classics Series]

This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials

1. This study found that patients with chronic heart failure and reduced ejection fraction who received vericiguat had lower rates of composite cardiovascular death and first hospitalization for heart failure (35.5%) compared to controls (38.5%).

2. Rates of symptomatic hypotension and syncope did not differ between the those on vericiguat as compared to placebo.

Original Date of Publication: May 2020

Study Rundown: The Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction (VICTORIA) trial assessed the impact of the novel oral soluble guanylate cyclase stimulator vericiguat on cardiovascular outcomes in patients with chronic heart failure and ejection fraction of less than 45%. The primary outcome of composite cardiovascular death and first hospitalization due to heart failure was significantly lower in patients in the vericiguat group. Syncope and hypotension were slightly higher in the vericiguat group, although results were not statistically significant. The study had a limited follow-up time (median of 10.8 months) although differences between groups were seen starting at three months after baseline. In summary, the VICTORIA trial as the first multinational trial to evaluate the efficacy of vericiguat in reducing cardiovascular mortality and hospitalization in patients with severe heart failure.

Click to read the study in NEJM

In-Depth [randomized control trial]: In the VICTORIA trial, patients with New York Heart Association class II, III, or IV, an ejection fraction of less than 45%, and an elevated natriuretic peptide level were randomized to either receive vericiguat (n = 2526) or a placebo (n = 2524). The VICTORIA trial was double-blinded, and outcomes were adjudicated by a blinded independent clinical-events committee. The composite endpoint of cardiovascular death and initial hospitalization for heart failure occurred in 35.5% of the vericiguat group as compared to 38.5% of the placebo group (HR 0.90; 95%CI 0.82-0.98). The secondary endpoints did not differ significantly between groups, including symptomatic hypotension (p = 0.12) and syncope (p = 0.30). Although, anemia occurred in a higher proportion of vericiguat patients (7.6%) as compared to placebo (5.7%).

Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, et al. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. New England Journal of Medicine. 2020 May 14;382(20):1883–93.

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