Endovascular therapy outcomes for PAD similar vs. bypass, regardless of sex
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Key takeaways:
- Endovascular therapy confers similar outcomes and lower complication rates vs. bypass surgery for femoropopliteal peripheral artery disease.
- Outcomes were similar regardless of sex for each strategy.
Endovascular therapy with stent implantation confers similar outcomes and lower complication rates vs. vascular bypass surgery for symptomatic femoropopliteal peripheral artery disease, regardless of sex, a speaker reported.
The results of a pooled subanalysis of the REVIVE study were presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
“Women are underrepresented in PAD revascularization trials, and so far, no robust data exists on sex-specific outcomes related to revascularization strategy,” Serdar Farhan, MD, interventional cardiologist at Icahn School of Medicine at Mount Sinai, said during a press conference. “The optimal revascularization strategy in women with symptomatic PAD remains unknown and the treatment recommendations are mainly based on clinical trial data which predominantly enroll men.”
For the pooled REVIVE study, Farhan and colleagues assessed major clinical outcomes after endovascular therapy (EVT) with stent implantation compared with vascular bypass for symptomatic femoropopliteal PAD. REVIVE was an individual=patient-data analysis incorporating five separate clinical trials, including a total of 639 patients.
As previously published in the Journal of the American College of Cardiology, in the main results of REVIVE, there was no significant difference between EVT and vascular bypass for major adverse limb events, amputation-free survival and the other secondary endpoints except for primary patency, which was lower in the EVT group. EVT was also associated with lower early complication rates and shorter hospital stay compared with vascular bypass.
For the present analysis, Farhan and colleagues evaluated sex differences in outcomes of EVT compared with vascular bypass for symptomatic femoropopliteal PAD.
The cohort included 185 women and 454 men.
The primary endpoint was major adverse limb events at 2 years. The secondary endpoint was a composite of amputation-free survival, individual components of major adverse limb events and primary patency at 2 years. The main safety endpoint was a composite of death, bleeding or infection at 30 days.
The majority of lesions in both sex groups and intervention arms were complex, classified as TASC class D in more than 64% of the patients in each group.
Concomitant common femoral artery treatment was more common in the vascular bypass group compared with EVT for men (P < .001), but not for women (P = .412).
Technical failure was also more common among men undergoing EVT compared with vascular bypass (P < .001) when compared with women (P = .258).
Farhan and colleagues reported that the 2-year rates of the primary endpoint (P log-rank = .484) and composite secondary outcome (P log-rank = .834) were similar in the EVT and bypass groups both among men and women.
For the individual components of the primary endpoint, including all-cause death, major amputation, target limb reintervention and loss of patency, the researchers observed comparable rates in both treatment strategies in both men and women (P for interaction for all > .05).
30-day bleeding and infection was significantly higher among both men and women undergoing EVT compared with vascular bypass, and there was no significant interaction by sex.
Moreover, length of hospital stay was similar between men and women and significantly lower with EVT compared with vascular bypass (P < .001 for both sexes).
“In patients with symptomatic PAD involving the femoropopliteal segment, EVT with stent implantation vs. bypass surgery was associated with similar rates of 2-year major adverse limb event and amputation-free survival, lower rates of early complications and shorter length of hospitalization regardless of sex,” Farhan said during the press conference. “This pooled analysis of patient-level data further supports the efficacy and safety of endovascular therapy with stent implantation as an alternative to bypass surgery in women and men.”
Reference:
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Farhan S, et al. Featured clinical research part 2. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 2-4, 2024; Long Beach, California.
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