Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights.

ABSTRACT:

Background

The real impact of the degree of association (DoA) between endpoint components of a composite endpoint (CE) on sample size requirement (SSR) has not been explored. We estimate the impact of the DoA between death and acute myocardial infarction (AMI) on SSR of trials using use the CE of major adverse cardiac events (MACE).

Methods

A systematic review and quantitative synthesis of trials that include MACE as the primary outcome through search strategies in MEDLINE and EMBASE electronic databases. We limited to articles published in journals indexed in the first quartile of the Cardiac & Cardiovascular Systems category (Journal Citation Reports, 2015-2020). The authors were contacted to estimate the DoA between death and AMI using joint probability and correlation. W

SUBMITTER: Marsal JR 

PROVIDER: S-EPMC9769015 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature