Effects of local intracoronary paclitaxel delivery using the Remedy transport catheter on neointimal hyperplasia after stent implantation in a porcine model.

Overview

PURPOSE: To assess the effects of local paclitaxel delivery using the Remedy catheter on neointimal hyperplasia in a porcine model and compare these results to commercially available BMS and biodegradable polymer-coated paclitaxel-eluting stents (BP-PES). METHODS AND MATERIALS: A total of 31 stents were implanted into coronary arteries of 15 domestic swine including eight BMS, six BP-PES, and 17 BMS after intravasal paclitaxel delivery at doses of 250 μg (LPD250; n=9) and 500 μg (LPD500, n=6). All stents were implanted under quantitative coronary angiography (QCA) guidance to achieve a balloon/artery diameter ratio of 1.15:1.0. Twenty-eight days after the procedure, follow-up coronary angiography was performed, the animals were euthanized, and the coronary arteries harvested for histopathological analysis. RESULTS: At follow-up, QCA analysis revealed that lumen loss was significantly worse in BMS and in both LPD groups in comparison to BP-PES stents (P=.02). Histomorphometric analysis showed that the LPD500 group presented the highest percentage of area stenosis, achieving a statistically significant difference in comparison to BMS and BP-PES stents. CONCLUSION: Our study demonstrates that local paclitaxel delivery using the Remedy transport catheter in the two studied doses (250 and 500 μg) is not effective at neointimal hyperplasia inhibition.