SGLT2 inhibitors and vericiguat in real-world patients admitted for worsening heart failure

Abstract

Abstract Introduction Worsening heart failure (WHF) is an emerging concept that is defined by escalating signs and symptoms of heart failure (HF) in patients with chronic heart failure (CHF) despite stable therapy. After a WHF event, there is a vulnerable period in which the risk of hospitalization and mortality is high. Sodium-glucose-co-transporter inhibitors (SGLT2i) and vericiguat, a soluble guanylate cyclase stimulator (sGCs), have been investigated in patients with WHF bother during hospitalization (EMPULSE) and right after the discharge (VICTORIA and SOLOIST-WHF) in the management of this condition with positive results. Aims This study aims to investigate the eligibility of VICTORIA, SOLOIST-WHF and EMPULSE in real-world population of patients admitted for worsening heart failure (WHF) and to analyze the differences between these groups of patients. Material and methods In this retrospective cohort study, 275 patients admitted for worsening heart failure in our cardiology department between 2017 and 2022 were enrolled. The percentages of eligible patients according to VICTORIA, SOLOIST-WHF and EMPULSE inclusion and exclusion criteria were analyzed, then the differences between the characteristics of our population and trials population were evaluated. Results 83 patients (30,2%) were eligible according to VICTORIA trial criteria, 35 patients (12,7%) according to SOLOIST-WHF and 186 patients (67,6%) according to EMPULSE. Limiting factors were ejection fraction (EF) > 45% in VICTORIA, the presence of diabetes in SOLOIST-WHF and the cut-off levels of NT-proBNP and BNP. Our patients were older (mean 78 years and median 80 years) than trials populations (67 years; 69 years; 71 years). EF was higher (mean 38% and median 35%) than VICTORIA (29%) and than EMPULSE (31%), but similar compared to SOLOIST-WHF (35%). Estimated glomerular filtration rate (eGFR) was lower compared to VICTORIA (56,0 ml/min vs 61,5 ml/min) whereas higher compared to EMPULSE and SOLOIST (54,0 ml/min vs 49,2 ml/min vs 50,0 ml/min). Diabetes was less common in our population (32,7% vs 47,1% vs 100% vs 46,8%); on the other hand, there were higher levels of NT-proBNP (median 5080 pg/ml) in our population compared to trials (3377 pg/ml; 1816,8 pg/ml; 3299 pg/ml). Conclusion SGLT2i and vericiguat are important drugs in the management of WHF. At the moment, vericiguat can be used only in patients with EF < 45% and this is the most limiting factor, whereas SGLT2i can be used regardless of EF. These data show that their applicability is high in patients with WHF and that the characteristics of trials populations reflect a real-world population. More data are needed about the use of vericiguat and SGLT2i, mostly in the first days of hospitalization. Recommendations for how to manage patients with WHF must be defined, national and international registries of HF hospitalizations may resolve this issue.Eligibility of vericiguat and SGLT2iComparison of baseline characteristics