Real-world use of vericiguat in Italian clinical practice: insights from the OpTIMa-HF registry

Background/Introduction Results from the VICTORIA trial, which enrolled 5050 symptomatic patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) showed that vericiguat reduced the risk of cardiovascular (CV) death or first HF hospitalization by 10% versus placebo. However, real-world data on vericiguat use remain limited. Purpose The aim of this analysis was to describe real-world use, titration patterns, and short-term clinical, biomarker and echocardiographic trajectories in patients with HFrEF treated with vericiguat in Italian outpatient care. Methods We retrospectively collected data from patients with a new prescription of vericiguat across 24 centers participating in the OpTIMa-HF registry. Clinical characteristics, background therapy, and laboratory parameters were recorded at baseline and subsequent follow-ups. Primary endpoints included changes in vericiguat doses, changes in clinical and laboratory parameters, and occurrence of clinical events (all-cause death; composite of death or HF hospitalization; worsening HF defined as hospitalization for HF and/or outpatient IV diuretics). Results A total of 685 patients were included (mean age 70.4 ± 11.3 years; 25.5% women). Comorbidity burden was high (hypertension 72.3%, diabetes 41.6%, atrial fibrillation/flutter 29.5%, chronic obstructive pulmonary disease 25.5%), and signs of congestion were common, with pulmonary congestion in 46.1% of patients and peripheral edema in 37.8%. The predominant aetiology was ischaemic (67.6%). Median left ventricular ejection fraction (LVEF) was 30.0% (IQR 25.0; 35.0), median NT-pro-BNP was 2000.0 (IQR 1,400.0; 5,740.0), and median BNP was 550.0 (IQR 455.0; 650.0). After a median follow-up of 6.7 months, background HF therapies were largely stable, whereas significant reductions in loop diuretic prescriptions were observed (76.2% to 68.5%, p<0.001). Vericiguat was titrated to 10 mg in 51.5% and to 5 mg in 25.4% of patients, while 23.1% remained on suboptimal dose or discontinued therapy. Median LVEF significantly increased (+3.7%), whereas natriuretic peptides (NT-proBNP −41.2%; BNP −46.2%) and systolic blood pressure (−2.5 mmHg) significantly decreased. NYHA class improved significantly (p<0.001), with fewer patients in class III (46.3% to 31.4%) and IV (5.3% to 1.3%) and more in class I (5.3% to 9.2%) and II (42.8% to 43.4%). All-cause death occurred in 7.9%, the composite of death or HF hospitalization in 24.7%, and worsening HF in 23.2% of patients. Conclusion(s) In this real-world Italian HFrEF cohort, vericiguat was frequently well tolerated and associated with improved NYHA class, higher LVEF, and lower natriuretic peptides, although a minority of patients remained on a suboptimal dose or discontinued.