Consequences of Inaccurate Assumptions in Coronary Stent Noninferiority Trials: A Systematic Review and Meta-analysis.

ABSTRACT:

Importance

The outcome and interpretation of noninferiority trials depend on the magnitude of the noninferiority margin and whether a relative or absolute noninferiority margin is used and may be affected by imprecision in event rate estimation.

Objective

To assess the consequence of imprecise event rate estimations on interpretation of peer-reviewed randomized clinical trials.

Data sources

PubMed/MEDLINE was searched for articles published between January 1, 2015, and April 30, 2021.

Study selection

Noninferiority randomized clinical trials of coronary stents published in selected journals with clinical events as the primary end point.

Data extraction and synthesis

Two reviewers (M.S. and F.V.) independently extracted data on trial characteristics, noni

SUBMITTER: Simonato M 

PROVIDER: S-EPMC8811709 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature