LB-11 | Revascularization Strategies in Patients with Peripheral Arterial Disease Involving the Femoropopliteal Arteries: A Pooled Analysis of Individual Patient Data

Women are underrepresented in clinical trials on peripheral artery disease (PAD). No adequately powered study exists to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease in women. A literature search identified 6 randomized controlled trials comparing EVT with stent implantation (bare-metal, drug-eluting, or covered stent) versus BSx (vein or prosthetic material) in patients with symptomatic PAD involving the femoropopliteal segment. Principal investigators of 5 RCTs agreed to pool individual patient data. The primary endpoint was major adverse limb events (MALE), a composite of all-cause death, major amputation, or re-intervention of the target limb. Other endpoints included amputation-free survival (AFS), the individual components of MALE, and primary patency. Early complications were defined as a composite of any bleeding, infection, or all-cause death within 30 days of the procedure. Of a total of 639 patients investigated 185 (29.0%) were females. Baseline and procedural characteristics were comparable between patients randomized to EVT vs BSx. At 2 years, there was no significant difference in the incidence of MALE between EVT and BSx in women and men (40.6% vs 42.1%, p=0.764; hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.57-1.52 for women and 39.7% vs 34.4%, p=0.963; HR 0.98, 95% CI 0.69-1.39 for men, Pint=0.963). Similarly, there were no differences in AFS, individual components of MALE and primary patency between EVT and BSx regardless of sex. EVT compared to BSx was associated with a significantly lower rate of early complications at 30-days (8.7% versus 25.9.6%, p=0.002 in women and 5.9% versus 21.5%, p<0.001 in men; Pint=0.770) and significantly shorter hospital stay in both women and men (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). The findings of this pooled analysis of individual patient data support the efficacy and safety of EVT with stent implantation as an alternative to BSx in patients with symptomatic PAD involving the femoropopliteal segment regardless of sex.