Purpose: To report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.
Materials and methods: This was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford-Becker stage 3-6; P1-P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan-Meier (K-M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.
Results: From August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford-Becker stage was five at baseline and 37/50 (74.0%) were chronic total occlusions. Technical success was achieved in all cases (100%). Stented lesion length was 114.2 ± 36.9 mm (range 6-20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2% with an 86.1 ± 5.9% freedom from TLR and 87 ± 5.0% AFS (K-M estimates).
Conclusion: The TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.