Novel biodegradable polymer-coated, paclitaxel-eluting stent inhibits neointimal formation in porcine coronary arteries

Abstract

Background: Biodegradable polymer-coated stents may have positive effects on arterial healing, and reduce the need for prolonged antiplatelet therapy.

Aim: To assess the vascular effects of the biodegradable polymer proposed as a stent coating, as well as to evaluate inhibition of intimal hyperplasia by Biodegradable Polymer-Coated Paclitaxel-Eluting Stents (BP-PES, LUC-Chopin, Balton) in porcine coronary arteries.

Methods: A total of 19 stents were implanted into the coronary arteries of 13 pigs: seven bare metal stents (BMS), six biodegradable polymer-coated stents (PCS) and six BP-PES. Animals were followed up for 28 days. Additionally, 11 BP-PES were implanted in four pigs which were followed for 90 days. Twenty eight and 90 days after stent implantation, the control coronary angiography was performed. Subsequently, the animals were sacrificed, their hearts were extracted and the coronary arteries were isolated for further histopathological analysis.

Results: After 28 days, BP-PES stents effectively limited neointimal hyperplasia in comparison to the control group (LL = 0.48 +/- 0.06 for BMS vs 0.87 +/- 0.16 for PCS vs 0.15 +/- 0.05 mm for BP-PES; p < 0.05). However, at three months, a 'catch-up' effect in neointimal formation was observed. Histopathology demonstrated favourable safety, with complete endothelialisation and inflammation significantly decreased between one and three months.

Conclusions: It seems that the biodegradable polymer-coated, paclitaxel-eluting stent examined in the present study is both safe and feasible. This supports the first such study in humans being conducted.