The Experimental Study Of A Bioabsorbable Coating Paclitaxel-eluting Stent In A Porcine Peripheral Artery Model

Although compared with bare metal stent(BMS),drug-eluting stent(DES)is effective to reduce neointimal hyperplasia and in-stent restenosis(ISR),persistence of durable polymer may cause delayed vessel healing and inflammation,which is associated with late stent thrombosis and restenosis.Poly(lactic-co-glycolic acid)(PLGA)as a kind of organic macromolecule polymer could be degraded into lactic acid and hydroxyacetic acid which are human normal metabolic by-product.Using PLGA as coating material may solve complications caused by persistence of durable polymer.This study includes two sections.In the first section,the in vivo pharmacokinetic study of the self-expandable bioabsorbable coating paclitaxel-eluting stent was investigated during 28 days.This experiment used liquid chromatograph-mass spectrometer(LC-MS)method to determine paclitacel level remaining on the stent,in the target vessel wall,in the adjacent vessel wall and in the plasma in a porcine peripheral artery model.In conclusion,the self-expandable bioabsorbable coating paclitaxel-eluting stent could achieve accurate,stable and sustained drug-release.In the second section,the efficacy and safety of the self-expandable bioabsorbable coating paclitaxel-eluting stent were evaluated in 28 days,90 days and 180 days.This experiment which was randomized double-blind controlled tial used self-expandable bare metal stents as control and adopted a porcine peripheral artery restenosis model.Quality vascular angiography(QVA),histopathology and scanning electron microscope were applied to this experiment to evaluate the efficacy by minimal luminal diameter,luminal loss,neointima area,percentage of area stenosis and the safety by endothelialization scores,inflammation scores and injury scores.In conclusion,the self-expandable bioabsorbable coating paclitaxel-eluting stent could effectively inhibit neointimal hyperplasia and was safety.This animal experimental study showed the self-expandable bioabsorbable coating paclitaxel-eluting stent made in China not only could achieve accurate,stable and sustained drug-release,but also was efficacy and safety,which provied a new way to solve in-stent restenosis in perpheral artery disease(PAD)and informational references to further clinical study.