Results of the COMPASS trial analysed using win ratio compared with conventional analytic approaches.

Abstract

BackgroundWin ratio (WR) is a newer analytic approach for trials with composite endpoints that accounts for the relative importance of individual components. Our objective was to compare the results of the COMPASS trial analysed using WR compared with conventional statistical approaches. MethodsWe used an unmatched WR analysis for first and total (first plus recurrent) events to examine effects of rivaroxaban plus aspirin and rivaroxaban alone versus aspirin alone on primary efficacy (cardiovascular death, stroke, myocardial infarction), safety (modified International Society on Thrombosis and Haemostasis major bleeding), and net clinical benefit (primary efficacy plus fatal or critical organ bleeding) endpoints. We compared the WR results with those obtained using Cox proportional hazards regression model for first events and Anderson-Gill method for total events. We calculated the win difference to estimate absolute treatment effects. ResultsThe WR approach produced results consistent with those obtained using conventional statistical methods for the primary composite endpoint (first event: WR 1.32, 95% CI: 1.14 to 1.52; Cox HR 1.32, 95% CI: 1.16 to 1.52; total [first plus recurrent] events: WR 1.32, 95% CI: 1.14 to 1.52; Anderson-Gill HR 1.32, 95% CI: 1.16 to 1.54) as well as for main safety and NCB endpoints. The absolute benefits of the combination of rivaroxaban and aspirin compared with aspirin alone calculated using the win difference were greatest in those with multiple high-risk features. ConclusionRe-analysis of the COMPASS trial results using WR produced results that were consistent with those obtained by conventional statistical approaches.