Introduction: The popliteal artery is a vessel considered unfavorable for the implantation of a stent due to the forces exerted in the popliteal fossa during limb flexion, which could fracture the stent antlers and compromise the outcome of the procedure at long-term. So far, stents used in popliteal lesions have not been compared with balloon angioplasty. The ETAP study is the first study in humans or FIM (first in man) comparing stenting with nitinol, (LifeStent ®), versus balloon angioplasty.
Methods and Results: 246 patients were included in nine European centers, being randomized 1:1. The primary object was restenosis rate at one year. Secondary objectives were restenosis at 6, 12 and 24 months, primary artery permeability as well as reintervention of target lesion. The medium length of lesions was 44 mm, with 33% of occlusions. After 12 months, the artery permeability observed was 44.9% in the angioplasty group versus 67.4% stent implantation (p <0.05). There was a lower rate of reoperation at 12 months with stent implantation (15.4 versus 50.4%, p = 0.0001). The stent fracture rate at one year was 3.4%.
Conclusion: Stent fracture on popliteal injury is not a common occurrence with the use of nitinol modern stents and does not invalidate the use of stents for such injuries. Stent implantation was superior to conventional angioplasty for the treatment of popliteal lesions. Future studies should examine the role of stenting in this era of drug-eluting balloon angioplasty.
Original title: Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions – Balloon Angioplasty versus primary Stenting: A prospective, multi-centre, randomised study ETAP