Disparities in Reporting and Representation by Sex, Race, and Ethnicity in Endovascular Aortic Device Trials

By FYH News Team

Published on June 1, 2022

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J Vasc Surg. 2022 May 24:S0741-5214(22)01590-7. doi: 10.1016/j.jvs.2022.05.003. Online ahead of print.

ABSTRACT

OBJECTIVE: Vulnerable populations including women and racial and ethnic minorities are 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’s (FDA) Medical Devices Database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999-November 2021. These included abdominal and thoracic endovascular aortic repair devices (EVAR and TEVAR), fenestrated devices (FEVAR), and dissection stents. Multiple approvals for expanded indications were included separately. Primary outcomes included the proportion of trials reporting participant sex, race, and ethnicity and the proportion of enrolled participants across sex, racial, and ethnic groups.

RESULTS: There were 29 FDA approvals for 24 devices: 15 EVAR (52%), 12 TEVAR (41%), 1 FEVAR (3.4%), and 1 Dissection stent (3.4%). These trials included a total of 4,046 patients. Of the 29 approvals, all reported on sex, and median female enrollment was 21% [IQR 11-34%]. EVAR trials had the lowest female enrollment (11% [8.7-13%]), compared with 41% [27-45%] in TEVAR trials, 21% for the FEVAR trial, and 34% for the dissection stent trial (P<.01 for difference). Only 52% of trials reported the 3 most common racial groups (White, Black, Asian), and only 48% reported Hispanic ethnicity. TEVAR trials were the most likely to report all 3 racial groups and Hispanic ethnicity (92% and 75%, respectively), while EVAR trials had the lowest reporting rates (13% and 20%). Where reported, median enrollment of racial and ethnic groups across trials was as follows: Black patients 9.8% (FEVAR: 0%, EVAR: 1.9%, TEVAR: 12%, dissection stent: 25%; P=.01); Asian patients 2.4% (EVAR: 0.6%, FEVAR: 2.4%, TEVAR: 2.5%, dissection stent: 11%; P=.24); Hispanic patients 3.8% (EVAR 1.3%, FEVAR: 2.4%, TEVAR: 3.9%, dissection stent: 4.1%; P=.75).

CONCLUSIONS: Racial and ethnic minority groups are underrepresented and underreported in pivotal aortic device trials that led to FDA approval. Female patients are also under-represented in aortic trials, especially for EVAR. These data suggest the need for standardization of reporting practices as well as minimum thresholds for minority and female participation in pivotal trials to promote equitable representation.

PMID:35623599 | DOI:10.1016/j.jvs.2022.05.003

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