Abstract
OBJECTIVE: This study evaluated the effectiveness and safety of a novel endograft with a biodegradable coating at both ends in preventing edge stenosis in swine iliac arteries. The biodegradable coating was composed of polylactide and paclitaxel. METHODS: Four types of endograft were implanted in the iliac arteries of healthy swine: an endograft without coating (control group) and endografts with polylactide and paclitaxel coating containing 0.1, 0.3, or 3.6 μg/mm(2) of paclitaxel. The edge stenosis of these endografts in swine iliac arteries was assessed using angiographic image data at 30, 90, and 180 days after the operation. After terminal angiography, histologic evaluation of the treated arteries was performed. The treated sections of iliac arteries and blood samples were obtained at 1, 7, 30, 90, and 180 days for pharmacokinetic analysis. RESULTS: The results of angiographic and histologic evaluation demonstrated that intimal hyperplasia contributed to edge stenosis and polylactide-paclitaxel coating effectively inhibited edge stenosis. At 30 days, edge stenosis was observed at both the proximal and distal edges of the endograft without coating. At 90 days, edge stenosis was detected for the endograft coated with 0.1 μg/mm(2) paclitaxel, and ectasia dilation occurred at the proximal and distal edges of the endograft coated with 3.6 μg/mm(2) paclitaxel. No edge stenosis or other adverse effects were observed at 90 and 180 days for the endograft coated with 0.3 μg/mm(2) paclitaxel. In addition, for the endograft coated with 0.3 μg/mm(2) paclitaxel, a pharmacokinetic analysis showed that the paclitaxel concentration of treated segments decreased from 14 264 ± 1020 ng/g at day 1 to 80 ± 70 ng/g at day 90, and 20 ± 40 ng/g at day 180. The plasma paclitaxel concentration was low at day 1 and no longer detected after 7 days. CONCLUSIONS: Polylactide and paclitaxel coating containing 0.3 μg/mm(2) paclitaxel at both ends of endografts effectively and safely inhibits edge stenosis in swine iliac arteries.