Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry.

PURPOSE: To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment. METHODS: Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months. RESULTS: The primary patency rate was 99(95%CI 98-100)% at 1 month, 86(80-92)% at 6 months and 81(74-88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86-96)% at 6 months and 88(82-94)% at 12 months and a secondary patency of 94(90-98)% at 6 months and 90(84-95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency. CONCLUSIONS: The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.