Risk Model Validates Finerenone Effect in Heart Failure

TOPLINE:

The Prognostic Models for Mortality and Morbidity in Heart Failure With Preserved Ejection Fraction (PREDICT-HFpEF) tool effectively stratified cardiovascular risk, with risk being higher in the highest than in the lowest score quintile. Finerenone was consistently effective across risk levels in patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), with a large absolute benefit observed in high-risk patients.

METHODOLOGY:

• Researchers validated the performance of the PREDICT-HFpEF tool in the FINEARTS-HF trial (2020-2023), which assessed the efficacy and safety of finerenone in patients with HFmrEF/HFpEF.
• A total of 6001 participants (mean age, 72 years; 54.5% men) across 37 countries were included, all of whom had received diuretic treatment for ≥ 30 days before randomisation, had left ventricular ejection fraction ≥ 40%, and had elevated natriuretic peptide levels. Participants received either finerenone (titrated to 20 mg or 40 mg) or placebo.
• The PREDICT-HFpEF risk calculator used 16 independent predictors to evaluate 1- and 2-year outcomes, with model performance assessed using the Harrell C statistic.
• The PREDICT-HFpEF risk scores for the composite outcome of cardiovascular death or HF hospitalisation, cardiovascular death alone, and all-cause death were calculated and compared with observed outcomes.
• Patients were divided into quintiles according to their PREDICT-HFpEF score for cardiovascular death or HF hospitalisation.

TAKEAWAY:

• The PREDICT-HFpEF model performed well in predicting the composite of cardiovascular death or HF hospitalisation (C statistic, 0.71; 95% CI, 0.69-0.72), cardiovascular death alone (C statistic, 0.68; 95% CI, 0.66-0.71), and all-cause death (C statistic, 0.69; 95% CI, 0.67-0.71) at 2 years.
• The composite outcome occurred more frequently in the highest vs lowest risk quintile, with event rates of 23.1 (95% CI, 21.1-25.4) vs 2.6 (95% CI, 2.1-3.2) per 100 patient-years, aligning well with predicted risk.
• Relative risk reduction with finerenone remained consistent across risk quintiles for all outcomes.
• Absolute risk reduction with finerenone was greatest in high-risk patients, with the number needed to treat ranging from 200 in the lowest risk quintile to 21 in the highest risk quintile per 100 person-years of treatment.

IN PRACTICE:

“This analysis of the FINEARTS-HF trial reinforces the value of multivariable models in discriminating risk and highlights the discordance between physician assessment of the severity of HF and the risk of adverse outcomes,” the authors wrote.

SOURCE:

This study was led by Kirsty McDowell, MBChB, British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. It was published online on March 5, 2025, in JAMA Cardiology.

LIMITATIONS:

The study findings might not be applicable to all patients with HFmrEF/HFpEF, as participants were selected on the basis of specific clinical criteria. One variable was unavailable in the model for cardiovascular death or first HF hospitalisation. Other factors that could influence the outcomes were not included in the analysis.

DISCLOSURES:

The FINEARTS-HF trial received funding from Bayer AG. Several authors reported being employed by, receiving personal or consulting fees from, or having other financial ties with various pharmaceutical, biotechnology, and healthcare companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.