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.

[Stenting in superficial femoral artery and usCRP: Multicentric study SAFE in 255 patients]. / Stenting de l'artère fémorale superficielle et C-Reactive Protein ultrasensible (CRPus) : étude multicentrique SAFE de 255 patients.

OBJECTIVE: To evaluate mid-term primary patency of the femoral artery stenting in correlation with usCRP level and characteristics of the population, morphological aspect of the lesions and interventional techniques. METHODS: Patients were prospectively included in a multicenter study (18 centers in France) after stenting (SMART, Cordis Johnson & Johnson, Issy-les-Moulineaux, France) of the superficial femoral artery (SFA). Inclusion and exclusion criteria were based on recommendations and every day practice of the centers. RESULTS: Thus 255 patients (183 men; mean age: 69 years; range 44-92) were included. Technical success of the SFA stenting was 100% without any complications and primary angiographic success 97%. usCRP level increased significantly (p < 0.05) between before and 24h after SFA stenting. In the subgroup of patients without initial inflammation (n = 157), usCRP increased significantly (p < 0.05) in the group of patient with initial thrombosis and additional intervention (graft, amputation, angioplasty on other arterial bed) in the same procedure compared to the remaining patients. Restenosis rate was 12.4% (26/209 patients) at 7 ± 2 months. Before stenting, usCRP level was not predictive of a restenosis, whereas after stenting, an increase of the 24h usCRP level was significantly higher in the subgroup of patient with an occlusion at mid-term (8 patients; p < 0.05). CONCLUSION: This study demonstrated good patency at 7 months of SFA stenting with nitinol SMART with an increase of the usCRP level 24h after stenting in favour of the presence of an occlusion at mid-term follow-up.