The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities

医学 临床终点 置信区间 临床试验 随机对照试验 心力衰竭 事件(粒子物理) 区间(图论) 内科学 组合数学 数学 量子力学 物理
作者
SJ Pocock,Cono Ariti,Timothy Collier,Dee Dee Wang
出处
期刊:European Heart Journal [Oxford University Press]
卷期号:33 (2): 176-182 被引量:522
标识
DOI:10.1093/eurheartj/ehr352
摘要

The conventional reporting of composite endpoints in clinical trials has an inherent limitation in that it emphasizes each patient's first event, which is often the outcome of lesser clinical importance. To overcome this problem, we introduce the concept of the win ratio for reporting composite endpoints. Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. Consider a primary composite endpoint, e.g. cardiovascular (CV) death and heart failure hospitalization (HF hosp) in heart failure trials. For each matched pair, the new treatment patient is labelled a ‘winner’ or a ‘loser’ depending on who had a CV death first. If that is not known, only then they are labelled a ‘winner’ or ‘loser’ depending on who had a HF hosp first. Otherwise they are considered tied. The win ratio is the total number of winners divided by the total numbers of losers. A 95% confidence interval and P-value for the win ratio are readily obtained. If formation of matched pairs is impractical then an alternative win ratio can be obtained by comparing all possible unmatched pairs. This method is illustrated by re-analyses of the EMPHASIS-HF, PARTNER B, and CHARM trials. The win ratio is a new method for reporting composite endpoints, which is easy to use and gives appropriate priority to the more clinically important event, e.g. mortality. We encourage its use in future trial reports.
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