Use of the Gore Tigris Vascular Stent in Advanced Femoropopliteal Peripheral Arterial Disease

Abstract

Purpose: To prospectively evaluate the safety and efficacy of using the Tigris vascular stent (Gore, Flagstaff, Arizona) alone or in combination with the Viabahn stent (Gore) for revascularizing femoropopliteal Trans-Atlantic Intersociety Consensus (TASC) type B-D lesions with varying degrees of calcification.

Materials and methods: Patients with Rutherford stage ≥ 3 and TASC type ≥ B were included in the study. From January 2015 to April 2017, 31 segments in 31 patients (21 men, ovarall mean age 73.3 ± 9.2 years) were treated. The breakdown by TASC type and Rutherford stage were TASC B (n = 12), C (n = 6), and D (n = 13), and Rutherford 3 (n = 28) and 4 (n = 3). The lesions were located in the common femoral artery (n = 1), superficial femoral artery (SFA; n = 20), distal SFA to P1 (n = 3), popliteal P1 (n = 1), popliteal P1-3 (n = 3), popliteal P2-3 (n = 2), and 1 femoropopliteal bypass. There were 18 occlusions (58.1%) and 13 stenoses (41.9%). The mean diseased segment length was 15.5 ± 9.9 cm with 80.6% of moderate/severe calcification. The follow-up consisted of color Doppler ultrasound and clinical assessment at 1, 3, 6, 9, 12, and 15 months.

Results: Technical success was 100%. There were no periprocedural or postprocedural complications. The mean stented lesion length was 17.2 ± 10.5 cm with a mean follow-up of 13.1 ± 6.9 months. Primary patency rates at 6, 9, 12, and 15 months were, respectively, 100% (24/31 patients), 90.5% (21/31 patients), 88.9% (20/31 patients), and 80% (15/31 patients). The median postprocedural Rutherford stage was 1. Three occlusions occurred at 7, 9, and 14 months, leading to a target lesion revascularization of 9.7% and a secondary patency of 100% at 15 months. Logistic analysis results demonstrated that lesion length (P = .003) was associated with reocclusion. Amputation-free survival at 15 months was 100%. Intrastent restenosis was observed in four cases (12.9%) but none were associated with worsening of symptoms. No stent fractures were observed.

Conclusions: The Tigris stent used alone or in combination with a Viabahn stent for femoropopliteal TASC B-D lesions demonstrated acceptable 12-month primary patency with a low reintervention rate.