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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.
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