Background: In the endovascular therapy for the superficial femoral artery (SFA) a variety of stent devices can be used. Indications for endovascular intervention are increasing, since the 2007 TASC II consensus changed. Several, also multicentric -trials, evaluated the use and effectiveness of stent devices.
Aim: The present trial studied efficacy of long ev3 Protégé Everflex stents used in the treatment of long and complex occlusive lesions of the -superficial femoral artery (SFA) and the popliteal artery.
Materials and methods: The ev3 Protégé Everflex device (ev3 Inc., Plymouth, MN, USA) is a self-expandable nitinol stent consisting of a helical structure with spiral cell interconnections, making high flexibility and low fragility possible. Using a prospective follow-up programme, 103 consecutive patients who received 128 stents (150 mm average length) were included in this study. Pre- and postinterventional parameters were walk-ing distance, ABI, Rutherford categorisation and duplex ultrasound examination. In addition, stent fracture was excluded by radiograms. The mean follow-up period was 6 months.
Results: 128 stents were implanted in 103 patients. The average age was 71.1 years (range: 52-90 years). 44 % of the collective suffered from TASC II C and D lesions. The technical success was 100 %. Restenosis was found in 11.8 % of the cases (n = 16) and recanalised (n = 9). 4 bypass implantations and 2 major amputations were performed. A total of 6 stent fractures was found (4.7 %).
Conclusions: The Protégé stent is a safe device with favourable short-term results. Restenosis and fracture rates are low, but long-term results still have to be evaluated in the future.
Georg Thieme Verlag Stuttgart.New York.