Real-world one-year effectiveness and safety of vericiguat in patients with heart failure in Spain: results from the multicenter prospective VERISEC study

Introduction

The VICTORIA trial demonstrated that vericiguat, a soluble guanylate cyclase stimulator, reduces the risk of cardiovascular death and heart failure (HF) hospitalization in patients with HF and reduced ejection fraction (HFrEF) and recent decompensation. This study aims to assess the effectiveness and safety of vericiguat in patients with HFrEF in routine clinical practice.

Methods

VERISEC is a prospective, multicenter observational registry that consecutively enrolled patients who initiated vericiguat in addition to guideline-directed medical therapy. Data were collected from 41 Spanish centers over a 1-year follow-up period. Changes in functional class, biochemical markers, ventricular function, and clinical outcomes were analyzed.

Results

The enrolled population comprised 835 patients (78.9% male) with a mean age of 71.3 (SD: 11.2) years. Crucially, the patients were highly treated at baseline, with the majority receiving SGLT2 inhibitors (91.5%), beta-blockers (90.7%), RAASi (85.4%), and MRAs (79.8%). During the follow-up, the proportion of patients on quadruple therapy increased from 61.7% to 71.8% (p = 0.022).

Treatment with vericiguat was associated with significant improvements in cardiac status over 12 months (Figure 1). There was a clinically relevant decline in NT-proBNP levels, which fell from 5763.3 pg/mL (SD: 6704.1) to 4519.5 pg/mL (SD: 6460.1) (p < 0.001). Concurrently, the mean left ventricular ejection fraction increased from 30.3% (SD: 7.6) to 35.4% (SD: 11.1) (p < 0.001). Functional status also improved, with the percentage of patients in NYHA class II increasing from 55.6% to 62.2% (p < 0.001). Compared to the prior year, during treatment period follow-up a marked reduction in event rates was found. The mean number of HF decompensations requiring intravenous diuretics decreased from 1.34 (SD: 1.07) to 0.65 (SD: 1.32) (p < 0.001). Similarly, non-HF cardiovascular hospitalizations declined from 0.98 (SD: 1.44) to 0.39 (SD: 0.99) (p < 0.001) (Figure 2). Vericiguat was well tolerated, with a 13.4% discontinuation rate at 12 months, primarily due to symptomatic hypotension. Notably, higher baseline NT-proBNP predicted vericiguat withdrawal (OR: 1.06; 95% CI 1.03–1.08).

Conclusions

In this real-world cohort of patients with HFrEF and recent decompensation, vericiguat us was associated with favorable changes in functional class, natriuretic peptide levels, and ventricular function, as well as a lower incidence of HF events, with good tolerability.For image description, please refer to the figure legend and surrounding text.For image description, please refer to the figure legend and surrounding text.