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The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities
Stuart J Pocock1, Cono A Ariti, Timothy J Collier
1Department of Medical Statistics, London School of Hygiene and Tropical Medicine, UK. stuart.pocock@lshtm.ac.uk
European Heart Journal
|September 9, 2011
Summary
The win ratio offers a superior method for analyzing composite endpoints in clinical trials, prioritizing more critical events like mortality. This approach enhances the reporting of treatment effects for better clinical decision-making.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Cardiovascular Research
Background:
- Conventional composite endpoints in clinical trials often prioritize less critical events.
- This can obscure the true treatment effect on more significant outcomes, such as mortality.
Purpose of the Study:
- Introduce and validate the win ratio as a novel method for reporting composite endpoints.
- To provide a more clinically relevant prioritization of events within composite endpoints.
Main Methods:
- The win ratio method involves forming matched pairs of patients from treatment and control groups based on risk profiles.
- Events are ranked by clinical importance (e.g., cardiovascular death before heart failure hospitalization).
- The win ratio is calculated as the number of 'winners' (superior outcomes) divided by the number of 'losers', with statistical significance assessed via confidence intervals and P-values.
Main Results:
- The win ratio method was successfully applied to re-analyses of the EMPHASIS-HF, PARTNER B, and CHARM trials.
- This approach effectively prioritizes more clinically important events, such as mortality, over less critical ones.
Conclusions:
- The win ratio is an intuitive and effective method for reporting composite endpoints in clinical trials.
- It offers a clinically meaningful way to assess treatment effects by appropriately weighting event importance.
- Widespread adoption of the win ratio in future trial reports is encouraged.
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