aFor patients with multiple events, only the first event contributing to the composite endpoint is counted.
bHR (VERQUVO over placebo) and CI from a Cox proportional hazards model.
cFrom the log-rank test.
dBackground therapy included beta blocker, ACE inhibitor, ARB, MRA, or a combination of an ARNI.
eTotal patients with an event per 100 patient years at risk.
fARR, calculated as difference (placebo - VERQUVO) in event rate per 100 patient years.
Study Design
VICTORIA was a Phase 3, randomized, parallel-group, placebo-controlled, double-blind, event-driven, multicenter trial comparing VERQUVO to placebo when added to background HF therapy in 5,050 adult patients with NYHA class II-IV chronic HF and LVEF <45% following a worsening HF event (defined as HF hospitalization within 6 months before randomization or use of outpatient IV diuretics for HF within 3 months before randomization). Patients were treated up to the target maintenance dose of VERQUVO 10 mg once daily or matching placebo. The primary endpoint was a composite of time to first event of CV death or HF hospitalization.1
Definitions:
ACE = angiotensin-converting enzyme; ARB = angiotensin II receptor blocker; ARNI = combination of an angiotensin receptor and neprilysin inhibitor; ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; HFH = heart failure hospitalization; HR = hazard ratio; LVEF = left ventricular ejection fraction; MRA = mineralocorticoid receptor antagonist; N = number of patients in Intent-to-Treat (ITT) population; n = number of patients with an event; NNT = number needed to treat; NYHA = New York Heart Association; RRR = relative risk reduction; VICTORIA = Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.
Reference:
1. Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020;382(20):1883-1893.