Nitinol Stent Implantation Versus Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Lesions up to 10 cm in Length

TLDR

Endoluminal treatment of superficial femoral artery lesions remains controversial. The study aimed to assess whether nitinol stenting of lesions ≤10 cm reduces restenosis and improves 1‑year clinical outcomes compared with PTA. A randomized trial of 244 patients with a single superficial femoral artery lesion (mean 45 mm) compared implantation of a single Bard Luminexx nitinol stent to stand‑alone percutaneous transluminal angioplasty. At 1 year, restenosis occurred in 31.7 % of stented patients versus 38.6 % of PTA patients, and target lesion revascularization was 14.9 % versus 18.3 %; the difference was not statistically significant, so the anticipated 20 % reduction was not achieved.

Abstract

Background— Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year. Methods and Results— Two hundred forty-four patients (168 men; 66±9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) “crossed over” to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, −6.9%; 95% CI, −19.7% to 6.2%; P =0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, −3.3%; 95% CI, −13.0% to 6.4%; P =0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease. Conclusions— In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.