Coronary disease & ACSMeta-analysis
Aligning Coronary Stent Trial Enrollment With the U.S. Intended-Use Population
- Pooled analysis of pivotal coronary stent premarket approval studies
- multivariable regression
- modelling of site selection scenarios
Authors' conclusion
Coronary stent PMA studies do not fully reflect the IUP, owing to marked underrepresentation of minority participants and modest underrepresentation of women.
Study context
- Population
- US participants in pivotal coronary stent premarket approval (PMA) studies (2003–2018) across 196 sites
- Participants
- 8,859 participants · 9 studies
- Outcome
- Site characteristics predicting enrollment of minority and female participants; representation of the intended-use population (participant-to-prevalence ratio)
Pooled result
As reported in the abstract
- Minority participants (underrepresented)
- 12%; PPR = 0.48
- Women (underrepresented)
- 30%; PPR = 0.77
- Minority enrollment predicted by West and South regions, county minority population, population density, per-capita income
- R2 = 0.50; P < 0.001
- Female enrollment poorly predicted by site characteristics and site principal investigator (PI) gender (non-VA status only)
- R2 = 0.095; P < 0.001
- Female PIs
- <6%
Further pooled results
Modelled reallocation of enrollment from low to high minority-enrolling sites
- Black and Hispanic representation normalised
- Participant-to-prevalence ratios (PPRs) ≥0.80
- Non-Hispanic Whites representation maintained
- PPR = 1.00
Original publication
Aligning Coronary Stent Trial Enrollment With the U.S. Intended-Use Population. J Am Coll Cardiol. Published 28 April 2026. doi:10.1016/j.jacc.2026.01.088
Summarised from the published abstract; every number is checked against it