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Win Ratio Analyses Using a Modified Hierarchical Composite Outcome: Insights From PARAGLIDE-HF
Satoshi Shoji1, Derek D Cyr2, Adrian F Hernandez2
1Duke Clinical Research Institute, Durham, NC; Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
American Heart Journal
|November 6, 2024
Summary
Sacubitril/valsartan demonstrated consistent benefits over valsartan in heart failure patients with ejection fraction >40% to 60%. Sensitivity analyses confirmed these findings, supporting sacubitril/valsartan
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- The win ratio (WR) is an evolving metric for composite outcomes, balancing significant events with surrogate measures.
- Limitations of WR include the influence of lower-tier outcomes, necessitating sensitivity analyses.
- The PARAGLIDE-HF trial investigated sacubitril/valsartan versus valsartan in heart failure with preserved ejection fraction.
Purpose of the Study:
- To conduct a sensitivity analysis of the win ratio (WR) using modified composite outcomes.
- To assess the efficacy of sacubitril/valsartan compared to valsartan in a specific heart failure subgroup.
- To evaluate the utility of WR sensitivity analysis in clinical trials.
Main Methods:
- Secondary analysis of the PARAGLIDE-HF trial data.
- Focus on patients with ejection fraction >40% to 60% (N=357).
- Performed WR sensitivity analyses by modifying the hierarchical composite outcome (excluding NT-proBNP, altering NT-proBNP thresholds, including renal outcomes) and calculating win odds (WO).
Main Results:
- All WR sensitivity analyses consistently favored sacubitril/valsartan over valsartan.
- Excluding NT-proBNP: WR 1.49 (95% CI, 1.00-2.22).
- Adjusting NT-proBNP thresholds and including renal outcomes also showed significant benefits for sacubitril/valsartan.
Conclusions:
- Multiple WR sensitivity analyses confirm a consistent treatment benefit of sacubitril/valsartan in this heart failure population.
- The findings support the use of sacubitril/valsartan in patients with ejection fraction >40% to 60%.
- Prespecifying WR sensitivity analyses in future trials is recommended for comprehensive treatment effect assessment.
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