Long Stents for Long Femoropopliteal Lesions - First Results of 128 Protege Stents

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 TASCII consensus changed. Several, also multicentric trials, evaluated the use and effectiveness of stent devices. Aim: The present trial studied efficacy of long ev3 Protege 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 Protege Everflex device (ev3Inc., 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 walking 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: 52-90years). 44% of the collective suffered from TASCIIC and D lesions. The technical success was 100%. Restenosis was found in 11.8% of the cases (n=16) and recanalised (n=9). 4bypass implantations and 2 major amputations were performed. A total of 6 stent fractures was found (4.7%). Conclusions: The Protege 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.