Studies Show Need for Inclusive Approaches in Treatment of PAD

May 7, 2024—The Society for Cardiovascular Angiography & Interventions (SCAI) announced new clinical results highlighting the need for inclusive approaches and comprehensive examinations of treatment options for peripheral artery disease (PAD), including endovascular therapy and revascularization.

The studies are:

• “Revascularization Strategies in Patients with Peripheral Arterial Disease Involving the Femoropopliteal Arteries: A Pooled Analysis of Individual Patient Data” by Serdar Farhan, MD, et al
• “Disparities in Peripheral Artery Disease Inpatient Endovascular Interventions” by Awad Javaid, MD, et al

The findings were presented at the SCAI 2024 scientific sessions held May 2-4 in Long Beach, California. The abstracts are available online in JSCAI.

According to SCAI, the late-breaking results from the first study support the effectiveness and safety of endovascular therapy (EVT) with stent implantation as an alternative to bypass surgery (BSx) in both women and men with PAD.

Dr. Farhan et al conducted a literature search that identified six randomized controlled trials comparing EVT with stent implantation (bare-metal, drug-eluting, or covered stent) versus BSx with vein or prosthetic material in patients with symptomatic PAD involving the femoropopliteal segment.

As summarized in the SCAI press release, 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%) were female. Baseline and procedural characteristics were comparable between patients randomized to EVT versus BSx.

At 2 years, there was no significant difference in the incidence of MALE between EVT and BSx in women (40.6% vs 42.1%; P = .764; hazard ratio [HR], 0.93) and men (39.7% vs 34.4%; P = .963; HR, 0.98). Similarly, there were no differences in 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 (women, 8.7% vs 25.96%; P = .002; men, 5.9% vs 21.5%; P < .001) and significantly shorter hospital stay in both women and men (3.7 ± 5.7 vs 7.2 ± 4.3 days; P < .001 and 2.8 ± 3.2 vs 7.4 ± 5.1; P < .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,” commented Dr. Farhan in the SCAI press release. “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.”

Dr. Farhan, who is from the Icahn School of Medicine at Mount Sinai in New York, New York, continued, “Early diagnosis and guideline-directed medical therapy are key to improving outcomes of any treatment strategy for PAD.”

In the second study, Dr. Javaid et al found that women and Asian Americans were less likely to undergo endovascular revascularization (ER) compared to men and Caucasian patients.

“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,” commented Dr. Javaid in the SCAI press release. “The results reinforce the need to change current practice by using a more inclusive and multidisciplinary approach to PAD interventions.” Dr Javaid is a cardiologist at University of Nevada, Las Vegas in Las Vegas, Nevada.

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

As summarized in the SCAI press release, of the 148,755,036 adult hospitalizations, there were 17,173,000 (11.54%) with PAD, of which 680,025 (3.96%) underwent inpatient ER.

ER prevalence increased steadily from 2016 to 2020 (0.46% to 0.49%; P < .001). In BAM-PS multivariable regression adjusting for several clinical and demographic variables, female versus male 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 < .001). There were no significant differences in ER mortality and cost when analyzed by sex, race, and income (P > .05 for all).

SCAI President George D. Dangas, MD, stated in the press release, “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, 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.”