Efficacious use of nitinol stents in the femoral and popliteal arteries.

OBJECTIVE: To evaluate the performance and identify predictors of outcome after the use of self-expanding nitinol stents in the treatment of femoropopliteal arterial occlusive disease.
METHODS: A retrospective analysis of a prospectively collected database was performed. Outcomes of patients who underwent placement of a nitinol stent in the femoral or above-knee popliteal arteries between 1999 and 2002 were studied. Patency, limb salvage, and patient survival were determined by Kaplan-Meier estimation and intergroup comparisons by log-rank test and Cox proportional hazards model. To define individual factors associated with clinical outcomes, stepwise regression analysis was performed.
RESULTS: A total of 41 patients (mean age, 70 +/- 10 years; gender, 26 men and 15 women) underwent percutaneous placement of nitinol stents. Limb salvage was the indication for intervention in 68% of patients. Diabetes was present in 54%, and 36% had end-stage renal disease. Nitinol stents were placed in the superficial femoral (35 patients) or the above-knee popliteal (6 patients) arteries. The mean postprocedural increase in ankle-brachial index was 0.32 +/- 0.19. The 6-month, 1-year, and 2-year primary patency and limb-salvage rates were 95%, 84%, and 84%, and 92%, 89%, and 89%, respectively. Major amputations occurred only in patients undergoing limb-salvage procedures presenting with major tissue loss. No statistically significant differences in patency were seen with regard to diabetes, end-stage renal disease, runoff score, length of vessel stented (median, 80 mm), hypertension, or smoking.
CONCLUSIONS: Our initial experience with self-expanding nitinol stents for femoropopliteal occlusive disease appears to demonstrate acceptable patency and limb-salvage rates at these early time points. Further evaluation of clinical outcome with these devices in this and larger groups of patients is warranted.