Studies Reveal Underrepresentation of Women and Hispanic Populations in PAD Treatment

May 7, 2024—The Society for Cardiovascular Angiography & Interventions (SCAI) announced that new study findings underscore gaps in clinical trial representation of women and Hispanic populations for peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI) research.

According to SCAI, despite an increase in recent research associated with PAD diagnosis and treatment, gaps in evidence-based conclusions on the effect of PAD and the best treatment options are present, with only 41.2% of clinical trial participants who are women and 11% who identify as Hispanic.

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

Dr. Dangas continued, “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.”

These three study results were presented at the SCAI 2024 scientific sessions held May 2-4 in Long Beach, California, with the abstracts available online in JSCAI:

• “The Existing Disparities Among the Hispanic Population in Clinical Studies Evaluating Drug-Coated Balloon for Treatment in PAD/CLTI” by Anthony Pham et al. The lead investigator was Mohammad M. Ansari, MD, from Texas Tech Health Science Center School of Medicine in Lubbock, Texas. Pham, the study presenter, is an MD candidate at Texas Tech School of Medicine.
• “The Gender Gaps Among Clinical Studies Evaluating Drug-Coated Balloon for Treatment in PAD/CLTI” by Anthony Pham et al.
• “Sex Comparison in Peripheral Artery Disease: Unveiling the Asymptomatic Profile in Women” by Jordyn O’Dell and Frank Annie, PhD. O’Dell, the study presenter at SCAI, is an MD candidate at Charleston Area Medical Center in Charleston, West Virginia.

As summarized in the SCAI press release, the first study aimed to investigate the demographic participation of the Hispanic population while evaluating the usage of drug-coated balloons (DCBs) for the treatment of PAD.

The press release noted that 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 compared to non-Hispanic White adults with PAD. 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.

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 approximately 19% of the nation’s population.

According to the SCAI press release, the investigators reviewed and recorded studies registered on clinicaltrials.gov that explored the use of DCB in PAD. Out of all the studies reviewed, only four trials were identified based on the inclusion criteria, which included initial United States-based studies comparing DCBs against standard balloon angiography, and three reported race and or ethnicity information.

Of 1,816 total patients, only 3.74% identified as Hispanics. When compared to the United States Census and the estimated PAD prevalence data from 2000, Hispanics were inadequately represented among the clinical trials collected, concluded the investigators.

“The Hispanic population largely remains underrepresented in studies involving treatment devices for PAD despite being a dominant minority population affected by the debilitating disease,” commented Pham in the SCAI press release. “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.”

The second analysis noted that in evaluations of DCB usage for the treatment of PAD, only 34% of all clinical trial patients were women.

All United States–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 United States Census and a 2000 study of estimated PAD prevalence in the United States, the representation of women in such clinical studies was significantly disproportionate to males on all points.

Pham stated, “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. 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.”

The third study unveiled potential underdiagnosis of PAD in women compared to men based on lower mortality and amputation rates.

The investigators analyzed the prevalence of PAD based on sex using the Trinetx database. From January 2015 to October 2023, the database recorded 1,189,435 PAD cases (females, n = 604,430; males, n = 585,005). To address group disparities, a 1:1 propensity match was conducted, resulting in 526,227 matched pairs.

The study examined both sexes for cardiology and vascular comorbidities. The findings indicated a lower mortality rate from PAD in females compared to males (6.4% vs 7.7%; P < .001) within a 1-year timeframe. However, amputation rates were higher in males (2.6% vs 1.3%; P < .001) as were rates of acute myocardial infarction (7.3% vs 5.2%; P < .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,” stated O’Dell in the SCAI press release. “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.”