Highlights
In nine pivotal U.S. coronary stent premarket approval (PMA) trials spanning 2003 to 2018, racial and ethnic minority participants were substantially underrepresented, and women were also enrolled below their expected share of the intended-use population (IUP).
Site geography and surrounding community demographics were strongly linked to minority enrollment. In contrast, female enrollment showed much weaker site-level patterning, suggesting that improving sex representation will likely require strategies beyond site selection alone.
