Recent publications on Residual Risk

Composite endpoints are conventionally used in clinical outcomes studies to increase statistical power and precision. More recent outcomes studies in diabetes have tended to predominantly use a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (i.e. major adverse cardiovascular events or MACE), with or without the addition of hospitalization for unstable angina. This report argues that inclusion of this additional endpoint may be problematic, specifically with respect to subjective variability in its ascertainment and a lower prognostic relevance compared with the MACE outcomes, and thus the MACE outcomes may be more clinically relevant when evaluating treatment effects. Ultimately, there is no gold standard for a specific endpoint (either single or composite) for cardiovascular outcomes studies.