French multicenter experience with the GORE TIGRIS Vascular Stent in superficial femoral and popliteal arteries.

BACKGROUND: Preliminary results in small single-center studies after stenting with the GORE TIGRIS Vascular Stent (W. L. Gore & Associates, Flagstaff, Ariz) show promising short-term primary patency rates, but larger, multicenter studies are needed. This study therefore investigated the performance of the GORE TIGRIS Vascular Stent at three different centers in France in patients with symptomatic peripheral artery disease. METHODS: This retrospective, single-arm, multicenter cohort study included 215 patients with peripheral artery disease (Rutherford-Becker category 2-6) who were treated with the GORE TIGRIS Vascular Stent, a dual-component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. The efficacy end point was primary patency defined by freedom from binary restenosis as derived by duplex ultrasound imaging until 2 years after the intervention. Primary, secondary, and primary assisted patency rates at 3, 6, 12, 18, and 24 months were estimated by Kaplan-Meier analysis. RESULTS: The GORE TIGRIS Vascular Stent was used to successfully treat 239 lesions, of which 141 lesions were located in the superficial femoral artery and 98 in the popliteal artery. Patients were a mean age of 74 ± 12 years. Mean lesion length was 86.8 ± 44.7 mm. After 12 and 24 months, the overall primary patency rates were 81.5% and 67.2%, respectively, and primary assisted patency was 94.9% and 84.8%. Secondary patency was achieved in 99.1% at 24 months. CONCLUSIONS: Our multicenter experience with the GORE TIGRIS Vascular Stent demonstrates continued good results at 2 years for endovascular treatment of challenging obstructive superficial femoral artery and popliteal artery disease.