One-year multicenter prospective real-world study of vericiguat effectiveness and safety in Spain

To evaluate the effectiveness and safety of vericiguat in patients with heart failure and reduced ejection fraction (HFrEF) following recent decompensation in routine clinical practice in Spain.

VERISEC is a prospective, multicentre registry of 835 consecutive patients initiating vericiguat at 41 centres in Spain. Functional class, biochemical markers, ventricular function, and clinical events were analysed during a 1-year follow-up.

Patients (age 71.3 years [SD: 11.2], 78.9% male) received highly optimized baseline therapy: 91.5% SGLT2i, 90.7% beta-blockers, 85.4% RAASi, and 79.8% MRAs. Quadruple therapy remained stable (61.7% baseline to 63.0% at 12 months; P = .526). At 1-year follow-up, significant improvements were observed. NT-proBNP decreased from 3532.0 (IQR: 1689.3-6974.5) to 2291.5 pg/ml (IQR: 1063.0-5076.3; P < .001) and LVEF increased from 30.3% (SD: 7.6) to 35.4% (SD: 11.1; P < .001). NYHA class improved, with class II patients increasing from 55.6% to 62.2% (P < .001). Mean HF decompensations requiring intravenous diuretics decreased from 1.34 (SD: 1.1) in the preceding year to 0.65 (SD: 1.3) during follow-up. Non-HF cardiovascular hospitalizations decreased from 0.98 (SD: 1.4) to 0.39 (SD: 1.0). Vericiguat was discontinued in 13.4% of patients, primarily due to symptomatic hypotension (49.4%). Higher baseline NT-proBNP (per 1000-pg/ml increase) independently predicted discontinuation (OR: 1.06; 95% CI: 1.03-1.08; P < .001).

Vericiguat added to optimized quadruple therapy was associated with reverse remodelling, reduced NT-proBNP, improved functional class, and a numerical reduction in HF-related events in real-world HFrEF patients. These findings confirm the clinical utility and safety of vericiguat in routine practice.