Noninferiority margins exceed superiority effect estimates for mortality in cardiovascular trials in high-impact journals

OBJECTIVES: To determine, in a sample of noninferiority trials, the noninferiority margins (NIMs) and their relation to effect estimates in superiority trials, the rationale being that in general NIMs should be no larger than effects declared important in superiority trials. STUDY DESIGN AND SETTING: To identify cardiovascular trials published in high-impact journals with a statistically significant primary outcome involving mortality, we …