The Vascular Quality Initiative Assessment of the Bard Lifestent® for the Treatment of Popliteal Artery Occlusive Disease
Journal of vascular surgery
BACKGROUND: The Bard LifeStent® self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery (SFA) 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 (SVS) Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) 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 one-year. The primary efficacy outcomes were freedom from target vessel revascularization (F-TVR) and freedom from target lesion revascularization (F-TLR) at one-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 TLR 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 (CLTI) in 72%. The SFA-popliteal artery was stented in 38% and popliteal 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 one- and two-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 CLTI. F-TLR was 86% and F-TVR was 84% at 12-months. At discharge, lesion treatment success was 99% and procedural success 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. CONCLUSION: 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 PVI devices can be successfully conducted within the SVS VQI registry.
Bertges DJ, Eldrup-Jorgensen J, Eskandari MK, et al. The Vascular Quality Initiative Assessment of the Bard Lifestent® for the Treatment of Popliteal Artery Occlusive Disease [published online ahead of print, 2023 Aug 28]. J Vasc Surg. 2023;S0741-5214(23)01936-5. doi:10.1016/j.jvs.2023.08.122