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Use of Win Statistics to Analyze Outcomes in the DAPA-HF and DELIVER Trials
Toru Kondo1,2, Samvel B Gasparyan3, Pardeep S Jhund1
1British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
NEJM Evidence
|February 6, 2024
Summary
Dapagliflozin significantly improved composite heart failure outcomes, including patient-reported symptoms and total events, in the DAPA-HF and DELIVER trials. This analysis highlights the benefits of dapagliflozin for heart failure patients.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Heart failure (HF) trials typically use composite endpoints focusing on initial events and cardiovascular death.
- Patient-reported outcomes like symptoms and quality of life are crucial but often analyzed separately.
- Win statistics offer a method to integrate diverse outcomes hierarchically into a single composite endpoint.
Purpose of the Study:
- To evaluate the effect of dapagliflozin versus placebo on a hierarchical composite outcome in patients with heart failure.
- To assess the impact of dapagliflozin on cardiovascular death, total HF hospitalizations, urgent HF visits, and patient-reported symptom scores (KCCQ-TSS).
- To demonstrate the utility of win statistics in comprehensively analyzing treatment effects in HF trials.
Main Methods:
- Analysis of pooled data from the DAPA-HF (n=4744) and DELIVER (n=6263) trials.
- Inclusion of patients with New York Heart Association class II-IV HF and specific ejection fraction criteria or cardiac biomarkers.
- Examination of a hierarchical composite outcome including cardiovascular death, total HF hospitalizations/visits, and KCCQ-TSS change at 8 months.
Main Results:
- The win ratio for the composite outcome was 1.30 in the pooled cohort, indicating a benefit for dapagliflozin.
- Win odds (1.19) and net benefit (8.7%) favored dapagliflozin in the overall patient population.
- Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) accounted for the majority of wins and losses (52.4%) in the pooled analysis.
Conclusions:
- Dapagliflozin demonstrated significant improvement in integrated composite outcomes in both DAPA-HF and DELIVER trials.
- The drug effectively addressed patient-reported outcomes alongside cardiovascular events and deaths.
- Win statistics provide a flexible and comprehensive approach to presenting treatment effects in heart failure.
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