Primary patency of long-segment self-expanding nitinol stents in the femoropopliteal arteries.

PURPOSE: To report a retrospective cohort study of nitinol stent implantation in patients at high risk for restenosis owing to long-segment (> or =10 cm) femoropopliteal disease. METHODS: Sixty-five consecutive patients with peripheral artery disease underwent long-segment (> or =10 cm) femoropopliteal stent implantation using self-expanding nitinol stents after initial failure of plain balloon angioplasty (i.e., residual stenosis >30% or a flow-limiting dissection). Patients were followed for first occurrence of in-stent restenosis, defined as a >50% lumen diameter reduction by color-coded duplex sonography, with angiographic confirmation. RESULTS: Cumulative median length of the stented segments was 16 cm (interquartile range IQR] 12-25, absolute range 10-40) using up to 5 overlapping stents. During the median 8-month follow-up (IQR 6-11), no early thrombotic reocclusions occurred within 30 days, but 26 (40%) patients developed an in-stent restenosis. Cumulative freedom from restenosis at 6 and 12 months was 79% and 54% overall, respectively; at the same time periods, the rates were 84% and 71% in nondiabetic patients (n=41) versus 68% and 22% in diabetics (n=24) (adjusted hazard ratio 3.8, p=0.01). Cumulative stent length and number of implanted stents were not associated with restenosis. CONCLUSION: Midterm restenosis after long-segment femoropopliteal stenting using self-expanding nitinol stents remains a major problem, particularly in patients with diabetes mellitus. The midterm results in nondiabetics are encouraging.