Why is this study important? 

Peripheral artery disease (PAD) has a widespread impact on the general population, with more than two million patients in the U.S. afflicted. Despite its prevalence, women are underrepresented in peripheral vascular disease clinical trials. The optimal revascularization strategy for women with femoropopliteal disease remains unknown. 

What question was this study supposed to answer?   

Review of six prior randomized controlled trials (RCTs) comparing endovascular therapy of the (EVT) with stent implantation versus surgical bypass in patients with symptomatic PAD involving the femoropopliteal segment, specifically. The primary endpoint was major adverse limb events (MALE), a composite of all-cause death, major amputation, or re-intervention of the affected limb. Secondary endpoints included amputation-free survival (AFS), individual components of the composite primary endpoint, and primary patency. 

What did the study show?   

Endovascular therapy had similar rates of MALE and AFS when compared to bypass at two years, regardless of sex. The EVT group was found to have significantly lower rates of early complications at 30 days (8.7% versus 25.96%, p=0.002 in women and 5.9% versus 21.5%, p<0.001 in men) and shorter hospitalization in men and women (3.7±5.7 vs. 7.2±4.3 days, p<0.001 and 2.8±3.2 versus 7.4±5.1, p<0.001). 

This pooled individual patient-level data further supports the safety and efficacy of endovascular therapy in patients with femoropopliteal disease. Furthermore, it suggests that the benefit extends equally to women, a population that is underrepresented in many clinical trials.