What we want versus what we can get: a closer look at failure time endpoints for cardiovascular studies.
In this article, we review the use of all-cause mortality and the composite endpoint as the primary endpoint and propose a recurrent composite endpoint as an alternative primary endpoint. Some general suggestions to trialists and practitioners are provided. In summary, the use of the composite endpoint is an issue that needs clarification.
Song
Rui
R
Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina 27599-7420, USA. rsong@bios.unc.edu
Cook
Thomas D
TD
Kosorok
Michael R
MR
D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000401:mortality*; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical; D016896:Treatment Outcome