ABSTRACT
Objective To explore the feasibility of clinical application of biodegradable polymer-coated drug-eluting stent. Methods Thirty each of the drug-eluting stent or bare-metal stents were implanted randomly into the anterior descending arteries, circumflex and right canine coronary arteries of thirty healthy pigs. The pathological examination was taken at 2 weeks to 6 months after coronary angiography to investigate the inflammation, thrombosis and endothelialization. Results Macroscopic observation of the stented arteries demonstrated complete incorporation of stent wires into the arterial wall and smooth vessel lumens. There were no significant differences existing between two kinds of the stents in terms of thrombosis, inflammation and endothelialization. The lumen loss in the biodegradable polymer-coated drug-eluting stent group is less than that in the bare-metal stent group. Conclusion The biodegradable polymer-coated drug-eluting stent is promising with good biocom-patibility, blood compatibility and phyaicochemical stability after being implanted into pig coronary arteries. The blood vessel transplanted with the drug-eluting stents maintains a high patency rate due to rapid endothelialization.
ABSTRACT
Objective:To evaluate one-year efficacy and safety of sirolimus-eluting stent with biodegradable polymer coating (EXCEL stent) in treating patients with coronary artery disease. Methods:One hundred consecutive hospitalized patients with coronary artery diseases exclusively treated with EXCEL stents were prospectively enrolled.After undergoing porcutaneous coronary intervention (PCI) all patients received dual anti-platelet therapy with clopidogrel and aspirin for 6 months and followed by aspirin alone.The primary end point was major adverse cardiac events(MACE) at 12 months.The secondary end points included binary in-stent restenosis rate(ISR)measured by quantitative coronary angiography (QCA) analysis at mean 8 months post the index PCI procedure,and MACE at 30 days and 6 months. Results:All patients were successfully treated with EXCEL stents during PCI procedure.Among all 153 target lesions,127 lesions were type B2/C complex lesions (83.0%).The mean length and diameter of the target lesions were 29.42?15.90 mm and 3.17?0.53 mm,respectively.A total of 211 EXCEL stents were implanted with average stent number of 2.02?1.53 per patient.The mean stent length and diameter were 35.34?17.35 mm and 3.23?0.46 mm,respectively.Four patients (4.0%) reached the primary end point at 12 months,which were 4 target lesion re-PCI due to ISR.No death,MI,or in-stent thrombosis occurred during the 6-month aspirin treatment alone after comleting 6-month dual anti-platelet therapy.QCA analysis of 112 le- sions of 75 patients showed 3.6% (4/112) of in-stent restenosis and 5.4% (6/112) of in-segment restenosis. Conclusions:The initial registry study showed that comparison with the published data from previous pivotal studies of others drug-eluting stents,the EXCEL stent revealed similarly incidence of 12-month ISR and/or MACE for the real world patients with coronary artery disease.The anti-platelet regimen of 6-month clopidogrel treatment after EXCEL implantation was safe.This con- clusion requires further investigation by large scale,multi-center,and longer-term follow-up clinical trials.