FINEARTS-HF Trial: Finerenone Offers Significant Benefits for HF Patients Following Recent Worsening Events

"An analysis of the time since a patient's worsening heart failure (WHF) event indicated that the efficacy of finerenone in reducing the primary composite outcome was most pronounced when patients were enrolled within seven days of the WHF event (relative risk [RR] 0.74 compared to placebo). The effectiveness decreased as time elapsed, reaching a nonsignificant low for those enrolled more than three months after the WHF event (RR 0.99)," the researchers reported. However, this observed pattern did not achieve statistical significance as a treatment-by-time interaction.

Patients with heart failure (HF) who have experienced a recent worsening heart failure event are recognized as being at a significantly increased risk of recurrent hospitalization and mortality, regardless of their ejection fraction. Considering this, Akshay S. Desai, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA, and colleagues aimed to investigate the safety and efficacy of the nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone with the recency of a WHF event.

FINEARTS-HF trial was a randomized, double-blind, placebo-controlled study assessing finerenone in patients with heart failure and a left ventricular ejection fraction of ≥40%. In the prespecified analysis, the researchers evaluated the risk of cardiovascular (CV) events and the response to finerenone compared to placebo, focusing on the time interval from WHF to randomization (during or within seven days, seven days to 3 months, over three months, or with no prior WHF). The primary outcome was a composite of total (first and recurrent) WHF events and CV death, analyzed using a proportional rates method.

Based on the study, the researchers reported the following findings:

• Of 6,001 patients validly randomized to finerenone or placebo, 20.3% were enrolled during (12.5%) or within seven days (7.8%), 33.8% between 7 days and three months, and 15.6% >3 months from a WHF event; 30.3% had no prior history of WHF.
• Rates of the primary composite outcome varied inversely with time since WHF, with >2-fold higher risk in those enrolled during or within seven days of WHF compared with those enrolled >3 months from WHF or without prior WHF (risk ratio [RR]: 2.13).
• Compared to placebo, finerenone appeared to lower the risk of the primary composite to a greater extent in those enrolled within seven days of WHF (RR: 0.74) or between 7 days and three months of WHF (RR: 0.79) than in those >three months from WHF or without prior WHF (RR: 0.99); however, no definitive treatment-by-time interaction could be confirmed.
• Greater absolute risk reductions with finerenone were accordingly seen in those with recent WHF.
• The risk of adverse events, including hyperkalemia and worsening renal function, among patients assigned to finerenone did not increase in those with recent WHF.

The findings showed that patients with HFmrEF or HFpEF who experience a worsening heart failure event—regardless of the treatment setting—are at a higher risk for subsequent hospitalizations and mortality compared to those without a recent WHF event. However, they seem to benefit more significantly from finerenone.

"Since the risk of adverse events associated with finerenone does not appear to increase in individuals with recent WHF, and the absolute risk reductions are greater, this population could be an especially promising target for using finerenone in clinical practice," the researchers concluded.

Reference:

Desai A, et al "Finerenone in patients with a recent worsening heart failure event: The FINEARTS-HF trial" J Am Coll Cardiol 2024; DOI: 10.1016/j.jacc.2024.09.004.