Gore's Tigris Vascular Stent Evaluated in Multicenter French Experience
April 20, 2017—A study of a multicenter experience with the Tigris vascular stent (Gore & Associates) in France concluded that the device demonstrates continued good results at 2 years for endovascular treatment of challenging obstructive superficial femoral artery and popliteal artery disease. The study was published by Maxime Sibé, MD, et al in Journal of Vascular Surgery (2017;65:1329–1335).
The Tigris device is a dual-component stent consisting of a nitinol wire frame combined with a fluoropolymer interconnecting structure. The background of the study is that larger, multicenter studies were needed after preliminary results in small single-center studies of treatment with the Tigris vascular stent showed promising short-term primary patency rates. This study was conducted to investigate the performance of the Tigris stent at three different centers in France in patients with symptomatic peripheral artery disease.
As summarized in Journal of Vascular Surgery, this retrospective, single-arm, multicenter cohort study included 215 patients with peripheral artery disease (Rutherford-Becker category 2–6) who were treated with the Tigris device. The efficacy endpoint was primary patency, defined as 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.
The Tigris 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, reported the investigators in Journal of Vascular Surgery.