Abstract
Abstract
Aims
Hierarchical composite endpoints (HCE) analyzed using generalized pairwise comparisons (GPC) have been increasingly adopted in cardiovascular trials. Stratified, but not covariate-adjusted, win statistics have been frequently presented. We apply methods to a post hoc HCE for the randomized 100-patient CORTAHF pilot trial of short-term corticosteroid therapy in acute heart failure (AHF).
Methods and Results
The HCE comprised 90-day death, 90-day HF readmission, 30-day worsening HF, and 30-day change in EQ-5D visual analogue scale (EQ-VAS) score from baseline. Win statistics and patient ranks from worst to best outcome were derived from GPC. These ranks were used to produce site-stratified and baseline EQ-VAS-adjusted win odds.
Analysis of individual components suggested beneficial prednisone effects on 90-day HF readmission and 30-day WHF adverse events, with little effect on 30-day change in EQ-VAS. The win ratio and win odds were 1.82 and 1.71, respectively (both p
Conclusions
Patients’ ranks can be derived from GPC and used to estimate stratified and covariate-adjusted win statistics as well as to visualize the treatment effect. Use of a well-constructed HCE in a small pilot trial should be considered; a positive signal may support further examination of the treatment. A full analysis can aid in interpretation.