Studies highlight need for tailored treatment options for women with peripheral artery disease

New clinical results highlight the need for inclusive approaches and comprehensive examinations of treatment options for peripheral artery disease (PAD), including endovascular therapy and revascularization. The data were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions.

Despite a lack of awareness, PAD, in which arteries in the extremities—often the legs—become narrowed, reducing or cutting off blood flow, contributes to 400 amputations performed each day. Additional data has emerged that highlights how disproportionately impacted underserved communities.

According to a December 2023 American College of Cardiology (ACC) statement, data from up to 20 years ago highlighted racial and sex-specific disparities in treatment for PAD. This underscores the need for more recent information on how PAD treatment impacts genders and races (medication, lifestyle changes, angioplasty and stent placement, or bypass surgery).

“PAD is a prevalent and debilitating disease with serious consequences, especially for advanced cases that may have progressed due to lack of treatment, which is something that many clinicians are seeing in their patients today. Evidence-based data on treatment outcomes for all are critically important for individualized care,” said SCAI President George D. Dangas, MD, Ph.D., MSCAI.

“SCAI and its PAD Pulse Alliance partners have worked to close these gaps through the Get a Pulse on PAD campaign, which kicked off this year with resources for physicians and patients.”

Late-breaking results support effectiveness and safety of endovascular therapy with stent implantation as an alternative to bypass surgery in both women and men with PAD

Endovascular therapy (EV) or procedures can be a safe and effective treatment option for some patients with PAD. The minimally invasive aspect of EV therapy can be advantageous to many patients, including those at too high of a risk for open surgery.

A literature search identified six randomized controlled trials comparing endovascular therapy (EVT) with stent implantation (bare-metal, drug-eluting, or covered stent) versus bypass surgery (BSx) with vein or prosthetic material in patients with symptomatic PAD involving the femoropopliteal segment.

The primary endpoint was major adverse limb events (MALE), a composite of all-cause death, major amputation, or re-intervention of the target limb. Other endpoints included amputation-free survival (AFS), the individual components of MALE, and primary patency. Early complications were defined as a composite of any bleeding, infection, or all-cause death within 30 days of the procedure.

Of 639 patients investigated, 185 (29.0%) were female. Baseline and procedural characteristics were comparable between patients randomized to EVT vs. BSx.

At two years, there was no significant difference in the incidence of MALE between EVT and BSx in women (40.6% vs. 42.1%, p=0.764; hazard ratio [HR] 0.93) and men (39.7% vs. 34.4%, p=0.963; HR 0.98). Similarly, there were no differences in amputation-free survival (AFS), individual components of MALE and primary patency between EVT and BSx regardless of sex.

EVT compared to BSx was associated with a significantly lower rate of early complications at 30 days (8.7% versus 25.96%, p=0.002 in women and 5.9% versus 21.5%, p<0.001 in men) and significantly shorter hospital stay in both women and men (3.7±5.7 vs. 7.2±4.3 days, p<0.001 and 2.8±3.2 versus 7.4±5.1, p<0.001).

“While the findings of the study are of value considering the scarce data on PAD treatment in women, they are also a strong reminder that we must do better in enrolling women in PAD trials. Women remain underrepresented in PAD trials and concerted efforts are warranted to achieve adequate representation of women to improve our understanding of the disease and its management in both women and men,” said Serdar Farhan, MD, FACC, FESC, Icahn School of Medicine at Mount Sinai, NY, and lead author of the study.

“Early diagnosis and guideline-directed medical therapy are key to improving outcomes of any treatment strategy for PAD.”

Women and Asian Americans less likely to undergo endovascular revascularization

In this analysis, Bayesian machine learning-augmented propensity score translational (BAM-PS) statistics with multivariable regression was conducted for the largest US all-payor inpatient dataset, the National Inpatient Sample (NIS), from 2016 to 2020.

Of 148,755,036 adult hospitalizations, there were 17,173,000 (11.54%) with PAD, of whom 680,025 (3.96%) underwent inpatient endovascular revascularization (ER).

ER prevalence from increased steadily (0.46% to 0.49%, p <0.001). In BAM-PS multivariable regression adjusting for several clinical and demographic variables, female sex (odds ratio, OR, 0.54) and Asian versus Caucasian race (OR 0.66) significantly decreased the odds of ER. Medicare versus commercial insurance (OR 1.17) significantly increased the odds of ER (p<0.001). There were no significant differences in ER mortality and cost when analyzed by sex, race, and income (p>0.05 for all).

“Although not surprising, it is frustrating to see women and Asian Americans are less likely to undergo procedures that may prevent amputations or even death,” said Awad Javaid MD, cardiologist at University of Nevada, and lead author of the study. “The results reinforce the need to change current practice by using a more inclusive and multidisciplinary approach to peripheral artery disease interventions.”