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

Abstract Background The current representation of females and racial and ethnic minorities in cardiovascular trials is unclear. We evaluated these groups' inclusion in US 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 transplant. This yielded 178 US trials (159 completed, 19 active but not recruiting) started between September 1998 and May 2017, with 237,132 participants. To examine females' and racial and ethnic minorities' representation in these trials, we calculated participation-to-prevalence ratios (PPR). Values of 0.8-1.2 reflect similar representation. Results All 178 trials reported sex distribution, whereas only 76 trials (42.7%) reported racial distribution and 52 trials (29.2%) reported ethnic (Hispanic vs non-Hispanic) distribution. Among all trials, participants were 28.3% female, 11.2% Hispanic/Latino, 4.0% African American, 10.4% Asian, and 2.3% Other. The CABG PPR for females was 0.64, Hispanics 0.72, African Americans 0.28, and Asians 3.20. Between 2008-2012 and 2013-2017, the CABG PPR decreased for females (0.67→0.50) and African Americans (0.37→0.17) but increased for Hispanics (0.38→1.32) and Asians (3.51→4.57). Conclusions Participation in cardiovascular trials by females and minorities (except Asians) remains low. Given that inherent differences among the abovementioned groups could affect outcomes, balance is clearly needed. The engagement of our surgical leadership, community, and industry to address these disparities is vitally important.