Objective
To evaluate the 1-year efficacy and safety of the self-expanding nitinol stent in treatment of intermediate femoropopliteal lesions.
Patients and methods
This prospective study included patients with symptomatic (Rutherford grade 2–5) 5–15 cm femoropopliteal artery lesion between July 2014 and July 2016. Study end points were primary patency rate, improvement of Rutherford clinical criteria and ankle brachial indices, major adverse events (MAE), target lesion revascularization, and stent fracture.
Results
The study enrolled 45 patients. Technical success rate 100%. A total of 45 stents were implanted in 45 patients. A single stent was used for each lesion. The primary patency rate at 1 year was 75.5%. The mean Rutherford clinical criteria decreased from 3.84±0.85 at baseline to 0.71±0.84 at 1 year (<0.001). Compared with baseline, a significant improvement in ankle brachial indices was found at 12-month (0.93±0.16; <0.0001) follow-up visits. No MAE were present at 30 days. At 12 months, there was one MAE case that showed target vessel revascularization using angioplasty. Target lesion revascularization at 12 month was 8.9%. Stent fracture at 12 months was 4.4%. All stent fractures were type 1 fracture.
Conclusion
The outcome of the study demonstrates that the self-expanding nitinol stent is effective and safe device for treating intermediate femoropopliteal arterial lesions.