ACCESSING HEALTH EQUITY
An elegant solution
The importance of patient demographics in trial design By Hope Racine
enrollment criteria and endpoints, these include establishing a collaborative leadership team and enrolling diverse patient sites. To that end, many physician scientists are adding another crucial consideration into their trial design: patient demographics.
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That’s the genesis behind the ELEGANCE trial, led by Maureen P. Kohi, MD, FSIR, and sponsored by Boston Scientific. The ELEGANCE registry will look at outcomes in patients with peripheral arterial disease (PAD) who have undergone intervention for lesions in the peripheral vasculature using Boston Scientific drug-eluting devices—while pledging to enroll at least 40% women and 40% underrepresented minorities into the registry.
16 IRQ | WINTER 2023
esigning a successful clinical trial requires strategic thinking regarding all aspects of the study. Beyond
The problem with PAD data PAD is an extremely common and fast-growing disease worldwide. In the United States, it is estimated that 4–10% of adults aged 40 or over are affected by PAD, and the incidence increases with age.1
Current data estimates that
over 200 million people worldwide are impacted by PAD.2
Emerging data indicate that women may have different outcomes following
“Recent data demonstrate that women have a higher incidence and prevalence of PAD compared to men. Interestingly, women in their mid-80s are more likely
to die of PAD compared to similar-aged men.” —MAUREEN P. KOHI, MD, FSIR
“Since 1990, there has been a significant increase in the absolute numbers of PAD worldwide,” said Dr. Kohi. “This translates into approximately 75,000 annual deaths, half a million years lived with disability and over a million years of life lost.”
According to Dr. Kohi, there has been a longstanding belief that PAD is a “man’s disease.” “This myth is simply not true,” she said. “Recent data demonstrate that women have a higher incidence and prevalence of PAD compared to men. Interestingly, women in their mid-80s are more likely to die of PAD compared to similar-aged men.”
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