Disparities in reporting and representation by sex, race, and ethnicity in endovascular aortic device trials.

ABSTRACT:

Objective

Vulnerable populations, including women and racial and ethnic minorities, have been historically underrepresented in clinical trials. We, therefore, studied the demographics of patients enrolled in pivotal endovascular aortic device trials in the United States.

Methods

We queried the Food and Drug Administration (FDA) medical devices database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999 to November 2021. These included abdominal endovascular aortic repair (EVAR), thoracic EVAR (TEVAR), fenestrated EVAR (FEVAR) devices, and dissection stents. Multiple cases of approval for expanded indications were included separately. The primary outcomes included the proportion of trials reporting particip

SUBMITTER: Marcaccio CL 

PROVIDER: S-EPMC9613501 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature