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MedStar Health Research Institute is now enrolling patients with peripheral artery disease in an observational study of two devices used to treat the condition.
Diversity, equity, and inclusion (DEI) initiatives are the subject of focus throughout American society as governments, corporations, individuals, and medical researchers increasingly recognize the importance of including many different perspectives in their work. Research is the creation of new, generalized knowledge to advance health and every investigator wants their research to apply to all members of the community.
It’s no different for those studying peripheral artery disease (PAD), the narrowing or blockage of vessels that carry blood from the heart to the legs. A buildup of fatty tissue in the arteries, known as atherosclerosis, generally causes it.
There is an age-related increase in Americans living with PAD, with a prevalence of >20% in people older than 80. Given that the life expectancy of women exceeds the life expectancy of men, the overall atherosclerotic burden is likely to be higher in women. Although women make up roughly 50 percent of the U.S. population, they only make up approximately 33% of enrolling patients for medical device trials.
Among people of color, cardiovascular research imbalances are even higher. Black Americans develop peripheral artery disease at rates more than twice that of other ethnicities, yet they make up fewer than 7% of patients involved in research about PAD.
The reasons for such disparity are very complex and beyond the scope of this article. It involves social determinants of health, access to quality healthcare (such as transportation), and implicit bias known to exist in healthcare. Patient perception also plays a role since historical non-consensual medical experimentation has led to a reluctance to enroll in research.
At MedStar Health Research Institute, we’re not just talking about DEI; we’re doing something about it to improve the health of all our patients.
MedStar Health Research Institute studies are inclusive by design. The latest example of our focus on health equity is our strong participation in The Elegance Trial, This unique post-market study sets minimum enrollment goals of 40% women and 40% historically minoritized community members as it seeks to study the performance of devices to treat PAD in real-world conditions.
PAD: Twice as likely among Black people.
About 6.5 million people over 40 in the U.S. have PAD. Symptoms of PAD include pain in the legs with physical activity that goes away after resting, muscle weakness, hair loss, smooth skin that is cool to the touch, cold toes, or sores/wounds in the legs and feet that do not heal. Risk factors for developing PAD include:
- Age greater than 60
- Atherosclerosis (buildup of substances in the arteries)
- High blood pressure
- High cholesterol
Black men and women are about twice as likely to develop PAD as their white counterparts, yet Black Americans are less likely to be promptly diagnosed and treated. Treatment inequity can have serious consequences, including higher rates of amputation due to delays and more severe cardiovascular outcomes such as coronary artery disease and cerebrovascular disease, leading to heart attack and stroke.
The Elegance Trial is unique and essential because it assesses how treatments for PAD perform in patients in the real world and prioritizes the populations that need these treatments most.
The Elegance Trial: A focus on real-world equity.
The Elegance Trial is enrolling participants at clinical sites throughout the U.S. to study two devices that are used in clinical practice to help keep arteries open and blood flow in patients with peripheral artery disease: a drug-coated balloon and a drug-eluting stent, both designed to clear artery blockages and prevent them from coming back.
Enrolled patients are observed for five years, during which researchers collect data on their health, economics, and the performance of the PAD-treatment devices. Elegance seeks real-world data, so there are a few exclusion criteria—most interested patients with PAD treated with these devices can participate. This is vital as it allows patients with other conditions to participate in the trial, so researchers can learn how these devices function in the “real world.”
In an update delivered in November of 2022, investigators indicated their enrollment goals are finding success. So far, sites like MedStar Health Research Institute have enrolled 579 patients, 40% of whom are women and 41% of whom come from underrepresented backgrounds. More specifically, 20% of enrollees are Black, 9.5% are Asian American, and 8% are Latinx.
This early success is heartening, and here at MHRI, we’re seeing tremendous enthusiasm from patients of color and an eagerness to enroll. I attribute that excitement to the opportunity to be fairly represented in this unique trial. It is probably also beneficial that this study is a real-world, post-market analysis of approved devices that many patients would be treated with anyway, not an experimental new treatment being pushed to have increased enrollment in diverse populations.
From the perspective of understanding peripheral artery disease, this unique study is one of the first to take a systemic approach, ensuring that these products work well in all patients that are likely to receive them instead of most clinical trials that are disproportionately white males.
We continue to enroll patients in The Elegance Trial at MedStar Washington Hospital Center and MedStar Montgomery Medical Center. If you’re interested in getting involved, talk with your doctor about a referral.