Fallacies of Using the Win Ratio in Cardiovascular Trials: Challenges and Solutions.

The win ratio was introduced into cardiovascular trials as a potentially better way of analyzing composite endpoints to account for the hierarchy of clinical significance of their components and to facilitate the inclusion of recurrent events. The basic concept of the win ratio is to define a hierarchy of clinical importance within the components of the composite outcome, form all possible pairs by comparing every subject in the treatment group with every subject in the control group, and then evaluate each pair for the occurrence of the components of the composite outcome in descending order of importance, starting at the most important and progressing down the hierarchy if the outcome does not result in a win in either pair until pairs are tied for the outcome after exhaustion of all components. Although the win ratio offers a novel method of depiction of outcomes in clinical trials, its advantages may be counterbalanced by several fallacies (such as ignoring ties and weighting each hierarchal component equally) and challenges in appropriate clinical interpretation (establishing clinical meaningfulness of the observed effect size). From this perspective, we discuss these and other fallacies and provide a suggested framework to overcome such limitations to enhance utility of this statistical method across the clinical trial enterprise.