New study findings underscore gaps in clinical trial representation of women and Hispanics for peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI) research. All studies were presented today at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions,

Severe PAD that leads to CLTI affects two million patients in the United States, with 25% of them requiring an amputation within a year after diagnosis. Despite an uptick in recent research associated with PAD diagnosis and treatment, 41.2% of clinical trial participants are women and 11% identify as Hispanic—creating a gap in evidence-based conclusions on the effect of PAD and the best treatment options for these patient populations. .

“Regarding the management of PAD and CLTI, we’ve observed minimal progress in the accessibility of resources over time. There’s a pressing need for enhanced screenings and greater education of PAD, its risk factors, symptoms, and treatment among all genders and races, ” said George D. Dangas, MD, Ph.D., MSCAI, SCAI President.

“Our goal is for all patients to receive equitable care tailored to address these conditions effectively, and we believe sharing these findings is a first step in bringing awareness and addressing the startling gap. In addition, SCAI and its partners began the Get a Pulse on PAD campaign this year with the goal of working to address these disparities.”

Less than 5% of participants in trials evaluating the usage of DCB for the treatment of PAD identify as Hispanic.

Compared to non-Hispanic white adults with PAD, Hispanic adults with PAD are 80% more likely to be admitted to the hospital through the emergency room and experience longer hospital stays with higher treatment costs. There is also a correlation between Hispanic people facing disproportionately higher death rates from some health conditions, including diabetes, and a higher prevalence of obesity and uncontrolled high blood pressure—all of which can contribute to heart disease. Although increased efforts have been made to evaluate disparities in PAD, few studies have focused on identifying growing gaps among the Hispanic population, which accounts for about 19% of the nation’s population.

The study aimed to investigate the demographic participation of the Hispanic population while evaluating the usage of durg-coated balloon (DCB) for the treatment of PAD. Studies registered on ClinicalTrials.gov that explored the use of DCB in PAD were reviewed and recorded.

Out of all the studies reviewed, only four trials were identified based on the inclusion criteria, which includes initial US-based studies comparing the use of DCB against standard balloon angiography, and three reported race and or ethnicity information. Of 1,816 total participants, only 3.74% identified as Hispanics. When compared to the US Census and the estimated PAD prevalence data from 2000, Hispanics were inadequately represented among the clinical trials collected.

“The Hispanic population largely remains underrepresented in studies involving treatment devices for PAD despite being a dominant minority population affected by the debilitating disease,” said Anthony Pham, MD candidate at Texas Tech School of Medicine, and study presenter. “Moving forward, this lack of representation necessitates purposeful efforts from all health care providers to actively recruit participants utilizing culturally sensitive tools in order to achieve equitable participation of Hispanics in clinical research.”

Analysis highlights only 34% of all clinical trial participants are women when evaluating usage of drug-coated balloons for treatment in PAD

DCBs provide a relatively new treatment option for those with PAD that has the potential to reduce the rate of using stents, and thus reduce the rate of restenosis of the artery, creating greater effectiveness. There are many studies that demonstrate the benefits of DCBs; however, minimal research is available on the effect of treatment with DCBs in women with PAD.

A review of all US-based studies investigating DCBs in PAD registered on ClinicalTrials.gov with results was recorded. Of the trials identified, four investigated the efficacy of DCBs in PAD. Of 1,816 total participants, only 34% were female while the majority (66%) were male. Compared to the 2020 US Census and a 2000 study of estimated PAD prevalence in the US, the representation of women in such clinical studies are significantly disproportionate to males on all points.

“Women in studies evaluating the usage of DCB for PAD are grossly underrepresented. These findings bring to question the real-world validity of such studies in the peripheral endovascular space,” said Pham. “Engaging the clinical community is essential to bolster women’s involvement in PAD trials, furthering the aim of research findings to enhance health outcomes for individuals with PAD/CLTI.”

Data unveils potential underdiagnosis of PAD in women based on lower mortality and amputation rate than that of men.

While PAD and CLTI are present in most adults older than 50 years of age, women commonly manifest claudication symptoms (such as aching, cramping or pain in calves) or no symptoms at all. These easily ignored symptoms can lead to a greater chance of a missed diagnosis or delayed treatment in women.

The prevalence of PAD based on sex is analyzed using the Trinetx database. From January 2015 to October 2023, 1,189,435 PAD cases were recorded. The number of females with PAD was higher (604,430) compared to that of males with PAD (585,005). To address group disparities, within the study, a 1:1 propensity match was conducted, resulting in 526,227 matched pairs. The study examined both sexes for cardiology and vascular comorbidities. Findings indicate a lower mortality rate from PAD in females (6.4%) compared to males (7.7%, P<0.001) within a one-year timeframe. Additionally, amputation rates were higher in males (2.6% vs. 1.3%, P<0.001), as were incidences of acute myocardial infarction (AMI) (7.3% vs. 5.2%, P<0.001).

“It was surprising to see women tend to have less severe outcomes than men, which suggests we need to pay attention to diagnosing and treating PAD in women, who might be underdiagnosed due to being asymptomatic or having less severe symptoms,” said Jordyn O’ Dell, MD candidate at Charleston Area Medical Center and study presenter. “These findings advocate for a more nuanced approach to screening and treatment for PAD, emphasizing the need for gender-specific research to enhance the diagnosis of women with asymptomatic vascular conditions.”