Heart failure & cardiomyopathies
The Win Ratio Method in Heart Failure Trials: Lessons Learnt from EMPULSE
Primary result · Hierarchical composite: death, number of HF events, time to first HF event, ≥5-point difference in KCCQ total symptom score changeResult — go to the resultUnstratified win ratio 1.38 95% CI 1.11–1.71Authors' conclusion
The EMPULSE trial findings illustrate how deaths, clinical events and patient-reported outcomes can be integrated into a win ratio analysis strategy that yields clinically meaningful findings of patient benefit.
Study context
- Population
- Patients with acute heart failure (HF) after initial stabilization
- Participants
- 530 patients
- Comparison
- Empagliflozin vs placebo
- Primary endpoint
- Hierarchical composite of:
- Death
- Number of HF events
- Time to first HF event
- ≥5-point difference in KCCQ total symptom score change
- Follow-up
- 90 days
Methodological detailsmethodological analysis, stratified win ratio, placebo-controlled
- Methodological analysis
- Stratified win ratio
- Placebo-controlled
Primary result
As reported in the abstract
Hierarchical composite:
- Death
- Number of HF events
- Time to first HF event
- ≥5-point difference in KCCQ total symptom score change
Unstratified win ratio
1.38
95% CI 1.11–1.71
P = 0.0036
Empagliflozinvs Placebo
unstratified win ratio 1.38 (95% CI 1.11–1.71); P = 0.0036
- Win ratio, de novo acute HF
- 1.29
- Win ratio, decompensated chronic HF
- 1.39
Further findings
Win ratio by stratum (de novo acute HF; decompensated chronic HF) · 90 days
- De novo acute HF win ratio
- 1.29
- Decompensated chronic HF win ratio
- 1.39
Alternative hierarchy constructions
- Including both number of HF events and time to first HF event appears an unnecessary complication
- 5-point margin for Kansas City Cardiomyopathy Questionnaire (KCCQ) paired comparisons not statistically necessary
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
The Win Ratio Method in Heart Failure Trials: Lessons Learnt from EMPULSE. Eur J Heart Fail. Published 23 April 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →