Assessment of Noninferiority Margins in Cardiovascular Medicine Trials.

ABSTRACT:

Background

Noninferiority trials are increasingly common in cardiovascular medicine, but their reporting and interpretation are challenging, particularly when an absolute risk difference is used as noninferiority margin.

Objectives

This study aimed to investigate the effect of using absolute rather than relative noninferiority margins in cardiovascular trials.

Methods

We reviewed noninferiority trials presented at major cardiovascular conferences from 2015 to 2022 and published within the same period. Based on the actual versus anticipated event rates in the control group, we recalculated the absolute noninferiority margin and re-assessed the trial results. The primary outcome of interest was the proportion of trials with a different interpretation after recalculation

SUBMITTER: Greco A 

PROVIDER: S-EPMC11312784 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature