ALPS RESEARCH HIGHLIGHT INTERVIEW – In the groundbreaking BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial, a surprising and important observation emerged: female patients had fewer limb amputations than their male counterparts.
Dr. Katharine McGinigle, vascular surgeon-scientist and a board member of the American Limb Preservation Society (ALPS), led the gender-based secondary analysis of the trial.
Reflecting on the work, she shared:
“After the initial trial was published, many of the investigators formed working groups to analyze specific subgroups. I was fortunate to lead the gender-based research group. We wanted to deeply understand what was happening with the female participants — something all too often overlooked in large trials.”
Historical underrepresentation of women
Historically, women have been underrepresented in cardiovascular and vascular research, and many studies fail to report gender-stratified outcomes.
Yet gender can profoundly influence both disease progression and surgical outcomes.
“There are very few female-specific studies,” McGinigle noted. “We know that atherosclerosis risk changes dramatically pre- and post-menopause, and that women and men face different risks and technical challenges during vascular surgery.”
In their analysis, the team found that women with chronic limb-threatening ischemia (CLTI) who had autologous saphenous vein available for bypass surgery fared significantly better with open surgery than with endovascular treatment — mirroring the overall trial findings.
But more intriguingly, when compared with male patients, women had lower amputation rates, even though their comorbidity profiles and reintervention rates were similar.
“That was a really interesting and encouraging finding,” McGinigle explained. “It suggests that, within a high-quality care framework like BEST-CLI, we might be mitigating some of the disparities in outcomes that have been seen in prior retrospective studies.”
This finding could reflect the benefits of participating in a structured, protocol-driven care model and being treated at experienced, multidisciplinary centers.
“If females are plugged into a good healthcare regimen — like those at BEST-CLI centers — we may be able to reduce some of the gender disparities that exist in vascular outcomes. That’s our hypothesis,” said McGinigle.
Why It Matters
This work reinforces the importance of inclusive research and gender-stratified reporting in vascular surgery. It also highlights the need for patient-centered decision-making, ensuring that women are not overlooked when evaluating treatment strategies for limb-threatening ischemia.
“Our study isn’t definitive — it wasn’t powered for these subgroup analyses — but it’s a powerful signal. It shows us the direction we need to go,” McGinigle said.
Full author group: Katharine L McGinigle, Gheorghe Doros, Olamide Alabi, Benjamin S Brooke, Ageliki Vouyouka, Jade Hiramoto, Kristofer Charlton-Ouw, Michael B Strong, Kenneth Rosenfield, Matthew T Menard, Alik Farber, Kristina A Giles.
Read the full study here: https://pubmed.ncbi.nlm.nih.gov/39368637/
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