Optimal endovascular treatment in women with PAD requires continued investigation

HOLLYWOOD, Fla. — There is a “gender-related disparity” in the diagnosis, management and treatment of peripheral artery disease, according to a speaker at the International Symposium on Endovascular Therapy, who called for increased awareness, detection and continued research in women.

“[PAD] is underdiagnosed in women. … We can change that: we can increase our awareness; we can detect it earlier in women; we can be more aggressive when it comes to endovascular therapies. When it comes to the world of drug-coated balloons, there doesn’t appear to be a class effect. But I think [there] is still an open question as to whether there is a gender-related difference, and it needs to be investigated further,” Maureen P. Kohi, MD, associate professor of clinical radiology in the vascular and interventional radiology division at University of California, San Francisco, said here.

Differences between women, men

The prevalence of PAD is similar between men and women. However, women have a longer life expectancy compared with men, and will be more disproportionately affected with PAD in the future as the population ages, according to Kohi.

To date, PAD remains underdiagnosed in women, and women have been underrepresented in contemporary trials of PAD revascularization strategies, she said.

Moreover, management and treatment strategies in women with PAD may differ from those in men. For example, women present with different comorbidities for PAD. Female-specific comorbidities include depression, hypothyroidism, arthritis, osteoporosis and inflammation, according to Kohi. In addition, compared with men, women are more likely to present with advanced disease such as chronic leg ischemia, she said.

Recent data

During the ISET 2017 presentation, Kohi focused on recent data showing outcomes after endovascular intervention.

In one retrospective study of 258 patients (31% women) with infrainguinal arterial obstructive disease who received endovascular treatment, women were older and more likely to present with critical limb ischemia, but there was no difference in major outcomes or mortality. However, with longer-follow-up, there was a slight increase in a trend toward poor outcomes in women.

In a registry study published in the Journal of the American College of Cardiology in 2014, researchers investigated the impact of morbidity and mortality rates after lower-extremity PAD intervention. Of 12,379 participants included, 41% were women. The findings showed a “unifying consistent theme,” according to Kohi: women who present with PAD are older, have more advanced disease and more critical limb ischemia. Technical success of balloon-only or atherectomy-plus-balloon revascularization was more common in these sicker, older patients compared with their male counterparts, she noted. There was no difference in mortality, stroke or MI, although women did have a higher rate of vascular complications.

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In a more recent registry study, in which 50% of the cohort was female, there was no difference in mortality between men and women with PAD, but women had a higher 12-month reintervention rate.

“Something is happening where women have a higher reintervention rate at long-term follow-up,” Kohi said. “This could be because of this vicious cycle: women [with PAD] are older, sicker, have more advanced disease and undergo fewer lower-extremity interventions in their lifetime for this disease.”

Drug-coated balloons

“This begs the question: Is there a device out on the market that promises better long-term outcomes for us in the world of PAD? The answer is yes, drug-coated balloons,” Kohi said.

She discussed follow-up data from the THUNDER trial, in which women and men had similar short-term improvement in outcomes after DCB. However, at 5 years, the TLR rate was no different in women after treatment with a DCB or standard angioplasty, whereas men experienced a dramatic improvement in outcomes with DCB.

Two-year follow-up data from the IN.PACT SFA trial showed a high rate of primary patency after treatment with DCB (IN.PACT Admiral, Medtronic) vs. standard angioplasty among women and men, with no difference between the two groups.

Information from the FDA executive summary of the LEVANT 2 trial of a DCB (Lutonix 035, Lutonix/Bard) vs. standard angioplasty showed that women in the U.S. cohort did better with standard angioplasty, but the opposite was true in men. In the German subgroup of this trial, however, women outperformed men when it came to DCB and the safety profile favored women.

Results of the ILLUMENATE trial presented at the Leipzig Interventional Course in January showed improvements in primary patency and TLR up to 390 days with the DCB (Stellarex) and no gender gap between women and men.

Future directions

In the future, more trials are needed to evaluate the risk factors that lead to PAD in women and early detection will be necessary to continue to raise awareness, Kohi said.

Reference:

Kohi MP. Session IX: Superficial Femoral Artery Intervention: Are We Getting Anywhere with Technique and Outcomes? Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

FDA Executive Summary. Prepared for the Jun. 12, 2014, meeting of the Circulatory System Devices Advisory Panel. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM400614.pdf. Accessed on March 12, 2017.

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Disclosure: Kohi reports no relevant financial disclosures.

Editor’s Note: On March 13, this story was updated to include additional information from the presenter.