One Year Results in the Endovascular Treatment of the Femoro-Popliteal Segment with the Tigris® Stent in Patients with Critical Limb Ischemia

Abstract

Introduction: The endovascular treatment with stenting in the femoro-popliteal arterial segment is particularly challenging due to certain anatomical features and biomechanical forces to which it may be exposed. The purpose of this study is to report our 1-year results in term of efficacy of the dual stent (TIGRIS®) in the femoro-popliteal region in patients with critical limb ischemia (CLI). Methods: We included patients classified as Rutherford grade ≥4 that required Tigris stent implantation in the femoro-popliteal region from January 2012 to January 2018 in one center. Two groups were analyzed: Group A, patients receiving Tigris stent in the superficial femoral artery [SFA] (n=24) and Group B, in the popliteal artery (n=21). The stenting indication in group A was primary stenting in 14 cases and angioplasty (ATP) failure in 10 cases. All cases included in group B were due to primary ATP failure (residual stenosis >50%, dissection or recoil). Technical success, primary patency, secondary patency and limb salvage are described for the entire cohort and both groups. The follow-up visits consisted of clinical examination and color-doppler ultrasound at 3, 6,12 months. Kaplan-Meyer analysis was used to estimate outcomes measures at 3,6 and 12 months. The groups were compared using the log-rank text. Results: Sixty-one Tigris® stent were implanted in 45 patients with mean age 74,67± 1,6 years. More than 40% were classified as Rutherford V. Occlusion rate was 57,8%. The median follow-up was 12,02 months (range 3-72 months). For the entire series, technical success was 100%. Primary patency at 3 and 6 months was 91,1% and 84,4% at 12 months. Secondary patency at 3,6 and 12 months was, 95,6%, 93,3% and 86,7%, respectively. Limb salvage was 86,7% at 12-month analysis. The 2 groups were comparable for preoperative comorbidities. Patients in Group A had longer lesions (15,8mm vs 7,9mm, p=0,044) requiring longer and more stents (124,2mm vs 82,9mm, p=0,001). No difference in primary or secondary patency and limb salvage between both groups was found during follow-up. No stent fractures were reported. Conclusion: The Tigris® stent in the femoro-popliteal region has demonstrated high primary patency and limb salvage rate during the first year follow-up in complex cases such as those with CLI. No difference in patency rates regarding sector location of the stent was found. It is necessary to validate these results in the long term.