A novel biodegradable polymer-coated cobalt-chromium alloy sirolimus-eluting stent：evaluation in a porcine model / 中国介入心脏病学杂志

ABSTRACT

Objective To assess the safety and efifcacy of a novel biodegradable polymer-coated Cobalt-Chromium alloy sirolimus-eluting stent in a porcine model. Methods Bare metal stents (BMS) (n=15), commercial available EXcellstents (n=21), and Cobalt-Chromium alloy PLAG-coated sirolimus-eluting stents (Co-P-SES) (n=21) were implanted in left anterior descending coronary (LAD, n=28)and left circumflex coronary (LCX, n=13), and right coronary artery (RCA, n=16) of 30 mini-pigs randomly. Coronary angiography was performed 28 days, 90 days and 180 days after the stenting procedure to evaluate luminal loss (LL), and then, histomorphology analysis was performed. Results 28 days and 91 days after the implantation, there were no significant differences in LL, neointimal area, Inflammation score and endothelialization score among the three groups. 28 days after the implantation, better endothelialization was observed in Co-P-SES group compared with EXcellgroup under scanning electron microscope. 182 days after the implantation, there were larger lumen area and less neointimal area in Co-P-SES group compared with EXcellgroup under similar internal elastic lamina area[(4.31±0.94) mm2 vs. (2.62±1.17) mm2, P=0.020];[(1.87±0.53) mm2 vs. (0.84±0.41) mm2, P=0.004]with statistical significance. Conclusions The novel biodegradable polymer-coated Cobalt-Chromium alloy sirolimus-eluting stents showed similar safety compared with commercial available EXcellstents. There would be a better potential of the novel stent on inhibiting the neointimal proliferation and endothelialization. However, further preclinical study including long term endpoints and clinical study should be conducted in order to evaluate the safety and effectiveness of the novel Co-P-SES.