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LONG BEACH, California — Because women are underrepresented in clinical trials evaluating endovascular therapy with stent implantation and bypass surgery for symptomatic femoropopliteal peripheral artery disease (PAD), interventionalists have scant clinical evidence on which approach is best for their female patients. 

Now, a pooled analysis of data from the REVIVE study has shown that both procedures have similar outcomes in women and men, with endovascular therapy having an edge in some metrics.

"In patients with symptomatic PAD involving the femoropopliteal segment, endovascular therapy with stent implantation vs bypass surgery was associated with a similar rate of 2-year major adverse limb events and amputation-free survival, but a lower rate of complications and significantly lower lengths of hospitalization, regardless of sex," Serdar Farhan, MD, assistant professor at the Icahn School of Medicine at Mount Sinai in New York City, reported here at the Society for Cardiovascular Angiography and Intervention (SCAI) 2024 Scientific Sessions.

"This pooled analysis of individual patient data further supports the efficacy and safety of endovascular therapy with stent implantation as an alternative to bypass surgery in both women and men," he said.

The analysis drew on individual patient data for 639 participants in the REVIVE study.

The data came from five randomized controlled trials comparing the two procedures; of the participants, 185 (29%) were women. 

The goal, Farhan said, was to evaluate 2-year rates of major adverse limb events and other key outcomes such as amputation-free survival and primary patency. Shorter-term endpoints were 30-day complications related to a composite of bleeding, infection, and death as well as bleeding and infection as singular findings.

Where Are the Women in PAD Trials? 

"Women are underrepresented in PAD revascularization trials and, so far, no robust data exist on sex-specific outcomes related to revascularization strategy," Farhan said when he presented the results. "The optimal revascularization strategy for women with symptomatic PAD remains unknown, and the treatment recommendations are mainly based on clinical trial data, which predominantly enrolled men." 

At 2 years, the rates of major adverse limb events with endovascular therapy and bypass surgery were not significantly different for the two sexes, at 40.6% and 42.1% (P = .764), respectively, in women and at 39.7% and 34.4% (P = .963), respectively, in men. 

Rates of major adverse limb events, individual components of major adverse limb events, and primary patency were similar for the two procedures, regardless of sex. Endovascular therapy had significantly lower 30-day complication rates than did bypass surgery — 8.7% vs 25.9% (P = .002) in women and 5.9% vs 21.5% (P = .770) in men — along with significantly shorter hospital stays for both women (3.7 ± 5.7 vs 7.2 ± 4.2 days; P = .001) and men (2.8 ± 3.2 vs 7.4 ± 5.1 days; P = .001).

Farhan also reported 23 cases of technical failure in the endovascular arms — a rate of 2.9% (n = 3) for women and 9% (n = 20) for men — whereas none were reported in the bypass surgery arms.

Other key outcomes of endovascular therapy vs bypass surgery were: 

• A composite of bleeding, infection, and death: 8.7% vs 25.9%, respectively, in women (P = .002) and 5.9% vs 21.5%, respectively, in men (P < .001)
• Bleeding: 5.8% vs 14.8%, respectively, in women (P = .04) and 4.5% vs 8.2%, respectively, in men (P < .11)
• Infection: 2.9% vs 16%, respectively, in women (P = .001) and 0.9% vs 15%, respectively, in men (P < .001)
• Death: 1% vs 0%, respectively, in women (P = NA) and 0.5% vs 0.4%, respectively, in men (P < .96).

"Ideally, this means an operator has the choice to offer two strategies to the patient that are similarly effective," Farhan explained after his presentation.

"Interestingly, we saw that the composite of bleeding, infections, or death within 30 days is significantly less with endovascular therapy in both sexes," he added, noting that the rate of bleeding in women who had endovascular therapy was one third the rate in those who had bypass surgery, whereas in men, the bleeding rate with endovascular therapy was half that of bypass.

"It means that there might be a signal toward a lower risk of bleeding in the early phase in women than in men when we apply endovascular therapy with stent implantation instead bypass surgery," Farhan added. "However, we need larger studies to validate this."

Call for Broader Studies

This pooled analysis of REVIVE data reinforces the efficacy and safety of endovascular therapy for PAD for both sexes, said Ethan Korngold, MD, chair of structural and interventional cardiology at Providence Health Institute in Portland, Oregon.

However, he added, future studies of endovascular therapy for PAD should broaden their scope.

"It's notable that this trial focused on patients treated with stents," Korngold said. "I would love to see future research focus on other techniques that we use to treat PAD, whether it's drug-coated balloons or atherectomy, just to encompass the full range of endovascular treatments, but it's very encouraging that both sexes benefited from it and both did very well."

That focus on one specific therapy is perhaps the study's primary limitation, he said. "But I think these are great data, and we need to be doing more of this type of research to see the patients that we're reaching and to see how they benefit from this," Korngold added.