13Apr 2023
The Win Ratio Method in Heart Failure Trials: Lessons Learnt From Empulse

The Win Ratio Method in Heart Failure Trials: Lessons Learnt From Empulse

The EMPULSE trial evaluated the clinical benefit of empagliflozin versus placebo in 530 patients with acute heart failure using the stratified win ratio approach. The primary outcome was a hierarchical composite of death, number of heart failure events, time-to-first HF event, or a 5-point + difference in KCCQ-TSS change at 90 days. The unstratified win ratio analysis showed a ratio of 1.38 (95% CI 1.11, 1.71) P = 0.0036. The stratified win ratio analysis yielded a very similar result, with a ratio of 1.36 (95% CI 1.09, 1.68) P = 0.0054. Alternative ways of including HF events and KCCQ scores in the clinical hierarchy are presented, leading to recommendations for their use in future trials. The EMPULSE trial findings demonstrate how a win ratio analysis strategy can integrate deaths, clinical events, and patient-reported outcomes to yield clinically meaningful findings of patient benefit.

  • #cardiology

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