Sex, Racial, and Ethnic Disparities in U.S. Cardiovascular Trials in More Than 230,000 Patients.

Background: The current representation of female patients and racial and ethnic minorities in cardiovascular trials is unclear. We evaluated these groups' inclusion in U.S. cardiovascular trials.

Methods: Using publicly available data from ClinicalTrials.gov, we evaluated cardiovascular trials pertaining to coronary artery bypass grafting (CABG), heart valve disease, aortic aneurysm, ventricular assist devices, and heart transplantation. This yielded 178 U.S. trials (159 completed, 19 active but not recruiting) started between September 1998 and May 2017, with 237,132 participants. To examine female patients' and racial and ethnic minorities' representation in these trials, we calculated participation-to-prevalence ratios (PPRs). Values of 0.8 to 1.2 reflect similar representation.

Results: All 178 trials reported sex distribution, whereas only 76 (42.7%) trials reported racial distribution and 52 (29.2%) trials reported ethnic (Hispanic vs non-Hispanic) distribution. Among all trials, participants were 28.3% female, 11.2% were Hispanic/Latino, 4.0% were African American, 10.4% were Asian, and 2.3% were other. The CABG PPR for female patients was 0.64, for Hispanic patients was 0.72, for African American patients was 0.28, and for Asian patients was 3.20. Between 2008-2012 and 2013-2017, the CABG PPR decreased for female patients (0.67→0.50) and African American patients (0.37→0.17) but increased for Hispanic patients (0.38→1.32) and Asian patients (3.51→4.57).

Conclusions: Participation in cardiovascular trials by female patients and minorities (except Asian patients) remains low. Given that inherent differences among the previously mentioned groups could affect outcomes, balance is clearly needed. The engagement of our surgical leadership, community, and industry to address these disparities is vitally important.