The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease.

OBJECTIVE: The Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. METHODS: A single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. RESULTS: The mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. CONCLUSIONS: In this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Three-Year Clinical Outcomes Following Implantation of LifeStent Self-Expanding Nitinol Stents in Patients With Femoropopliteal Artery Lesions.

The aim of this study was to evaluate midterm clinical outcomes after implantation of LifeStent self-expanding nitinol stents for the treatment of femoropopliteal lesions. This retrospective, multicenter, non-randomized study examined 260 femoropopliteal lesions in 250 consecutive patients with peripheral artery disease implanted with LifeStents from April 2016 to April 2017. The prevalence of chronic total occlusion (CTO), lesion length ≥25 cm, and distal reference vessel diameter (RVD) <5 mm was 58%, 35%, and 50%, respectively. The 3-year restenosis rate in the overall population was estimated to be 72.9% and a major adverse limb event was observed in 36.9%. Multivariate analysis revealed that chronic limb-threatening ischemia (CLTI) (odds ratio [OR]: 8.04; 95% confidence interval [CI]: 1.86-34.7), CTO (OR: 4.87; 95% CI: 1.43-16.6), lesion length ≥25 cm (OR: 5.95; 95% CI: 1.11-32.0), and distal RVD <5 mm (OR: 4.43; 95% CI: 1.34-14.6) were independent risk factors for 3-year restenosis. The present study demonstrated the midterm clinical outcomes and risk factors for restenosis after implantation of the LifeStent in femoropopliteal artery lesions. CLTI, CTO, lesion length ≥25 cm, and distal RVD <5 mm predicted decreased patency after a 3-year follow-up.