Heart failure & cardiomyopathiesSecondary analysis
The Efficacy of Finerenone on Hierarchical Composite Endpoint Analysed Using Win Statistics in Patients with Heart Failure and Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of FINEARTS-HF
- Secondary analysis of the FINEARTS-HF randomised trial
- prespecified analysis
- win statistics
Authors' conclusion
Finerenone treatment led to a significant improvement in a composite hierarchical outcome that incorporated cardiovascular death, total HF hospitalizations, and total urgent HF visits, with early onset of benefit.
Study context
- Population
- Patients with heart failure (HF) and mildly reduced or preserved EFanalysed
- Participants
- 6,001 patients
- Comparison
- Finerenone vs placebo
- Finerenonen = 3,003
- Placebon = 2,998reference
- Primary endpoint
- Hierarchical composite:
- CV death (tier 1)
- Total HF hospitalizations (tier 2)
- Total urgent HF visits (tier 3)
- Follow-up
- 24 months
Primary result
As reported in the abstract
Hierarchical composite endpoint
Finerenone
825
events
Placebo
1012
events
Each group vs placeboWin ratio (95% CI)P value
Finerenone
1.17(1.04–1.32)
P = 0.010- Finerenone
- win odds 1.05 (95% CI 1.01–1.09)
- Finerenone
- net benefit 2.6% (95% CI 0.6–4.5%)
Further findings
Win odds at 12 months
- Win odds at 12 months
- 1.04 (95% CI 1.01-1.08)
- Win odds with KCCQ total symptom score added to the hierarchical endpoint as a continuous variable
- 1.07
- almost identical to the win ratio due to the decrease in ties
Win ratio over time
- Win ratio remained above 1.0 from 60 days after randomization and reached a plateau after approximately 12 months
Contribution of components
- HF hospitalizations contributed more to the overall results than CV death
Original publication
The Efficacy of Finerenone on Hierarchical Composite Endpoint Analysed Using Win Statistics in Patients with Heart Failure and Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of FINEARTS-HF. Eur J Heart Fail. Published 29 April 2025. doi:10.1002/ejhf.3669
Summarised from the published abstract; every number is checked against it