11.2 Health Equity

These proceedings summarize the educational activity of the 17th Biennial Meeting of the International Andreas Gruentzig Society held January 30 to February 2, 2024 in Chiang Rai, Thailand.

Faculty Disclosures     Vendor Acknowledgments

2024 IAGS Summary Document

Statement of the problem or issue

Studies show that patients in minority populations are not accessing specialty care due to barriers in our healthcare system. We have data demonstrating racial and ethnic under-representation in clinical trials, and particularly in cardiovascular clinical trials. It’s not that doctors and caregivers exclude certain patients on purpose; there are many factors involved. Some of it is due to unconscious bias; some of it is trust. There are many people of color who do not go to doctors from a lack of trust. These factors all combine to produce inequality in health care. We are all called to action to work together and close the gaps. There is a famous quote by Martin Luther King: “Of all the forms of inequality, injustice in health care is the most shocking and inhumane.” 

Gaps in current knowledge

For Black patients with peripheral arterial disease (PAD), they are twice as likely to undergo an amputation and less likely to have a revascularization procedure first. For Hispanics, they are 15% less likely to undergo a PCI procedure when presenting with heart attack symptoms. Among patients with atrial fibrillation, if you're a black patient, you account for less than 4% of left atrial appendage closure devices. In patients with heart failure, Black and Hispanic patients are less likely to receive CRT and ICD therapies. Our population is 51% female. Yet, females only represent ≈33% of patients enrolled in clinical trials. African Americans represent ≈14% of the population, yet they represent <7% of patients enrolled in clinical trials. Hispanics represent less than 6% of enrollees in clinical trials. So, we must get more demographically diverse patients engaged in clinical trials in order for them to begin to trust what is going on.

Possible solutions and future directions

At Boston Scientific we started a trial called Platinum Diversity (NCT02240810).¹ One of the myths we dispelled was that enrolling ethnically diverse patients would slow down enrollment. In fact, it was the second fastest enrolling trial in Boston Scientific history. Another myth: It’s hard to find diverse physician investigators (PIs). Well, with Platinum Diversity and the Elegance registry (which is focused on PAD), we not only had outstanding PIs that were a diverse group, but our entire steering committee was diverse, composed of women and people of color.² So, another myth: Diverse patient enrollment will create higher rates of loss to follow-up. Yet, in both of these studies, Platinum and Elegance, rates of loss to follow-up were comparable for minorities and white men. Diverse enrollment is not going to hurt your trial. Final myth for today: Enrollment caps will delay trials, and investigators don’t like them. In Elegance, enrollment caps haven’t delayed the trial at all. It’s a fast-enrolling trial, and we’ve received extremely positive feedback on enrollment caps. And, in addition, we’re doing a trial right now for left atrial appendage closure, and the strategy earlier was to first enroll 500 patients, and then at the 500-patient mark, stop that portion of the trial and switch enrollment to people of color only. We did just that. We plan to enroll 200 additional patients, and we’re enrolling them faster in the 200-patient arm than we did in the 500-patient arm. So, slower trial enrollment from patient caps is just another myth.

References

1. Avaliable at: clintrials.gov/study/NCT02240810. Accessed 01 May 2024.
2. Kohi MP, Secemsky EA, Kirksey L, Greenberg-Worisek AJ, Jaff MR. The ELEGANCE registry: Working to achieve equity in clinical research design. NEJM Catal Innov Care Deliv. 2023;4(8). DOI: 10.1056/CAT.23.0010