Reporting Of Race, Ethnicity And Sex In Endovascular Aortic Device Trials
Thomas FX O'Donnell, MD1, Christina L. Marcaccio, MD, MPH1, Kirsten D. Dansey, MD, MPH1, Priya B. Patel, MD, MPH1, Ruby Lo, MD, MPH2, Marc L. Schermerhorn, MD1.
1Beth Israel Deaconess Medical Center, Boston, MA, USA, 2Brown Surgical Associates, Providence, RI, USA.
OBJECTIVES: Recent attention has focused on the composition of clinical trials with respect to sex, race, and ethnicity. We therefore studied the demographics of patients enrolled in pivotal aortic device trials.
METHODS: We queried the United States Food and Drug Administrationís (FDA) Medical Devices Database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from 1999-2021. These included abdominal and thoracic endovascular aneurysm repair devices (EVAR and TEVAR), fenestrated devices (FEVAR) and aortic dissection stents. Multiple approvals for expanded indications based on new trial data were included separately. We then recorded the demographic data from the primary clinical study for each device, as reported in the FDAís Summary of Safety and Effectiveness Data.
RESULTS: There were 27 approvals for 23 aortic endovascular devices; 15 EVAR (56%), 10 TEVAR (37%), 1 FEVAR (4%) and 1 Dissection stent (4%). These trials comprised a total of 3,826 patients. Of the 27 approvals, all reported on sex, with rates of female enrollment ranging from 6.5% to 50%. EVAR trials enrolled the lowest rates of female participants (median 11% [IQR 8.8-13%]), compared with 37% [26-42%] in TEVAR trials, 21% for FEVAR, and 34% for the dissection stent. Only 41% of trials reported the four most common racial/ethnic groups (White, Black, Asian, Hispanic), and 48% reported no racial/ethnic groups or only reported the rate of White vs non-White participants. TEVAR trials were the most likely to report all 4 racial/ethnic groups (70%). EVAR trials had the lowest rates, with only 2 (13%) reporting all 4, and 12 (80%) reporting either no race/ethnicity data or White vs non-White only. The median proportion of Black patients was 9.9% (where reported); FEVAR: 0%, EVAR: 2.5%, TEVAR: 12%, dissection stent 25% (P<.01 for difference). No trial before 2008 reported more than one race/ethnicity, but since 2013 only 50% of trials reported all 4. CONCLUSIONS: Non-White racial and ethnic minority groups are under-represented and under-reported 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, and the need for improved minority and female engagement in future trials.
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