Effects of a novel cobalt-chromium alloy degradable coated sirolimus-eluting stent on neointima in a porcine coronary artery hyperdilation model
Release time:
2016-08-12 09:20
Source:
Objective To evaluate the safety and efficacy of L-605 cobalt-chromium alloy stent platform and polylactide-glycolide (PLGA) copolymer carrier sirolimus drug-eluting stent in a minipig model of coronary hyperdilation.
Methods Bare metal stents (BMS, 15 pieces), marketed degradable coated sirolimus drug-eluting stents (EXCEL, 21 pieces) and cobalt-chromium alloy PLGA copolymer carrier sirolimus drug-eluting stents (Co- P-SES, 21 pieces) were randomly divided into 30 minipigs with 28 anterior descending (LAD), 13 circumflex (LCX) and 16 right coronary artery (RCA). Coronary angiography was performed at 28 days, 91 days and 182 days after operation to evaluate the lumen loss (LL) and other indicators, and then the animals were sacrificed for histomorphological and histopathological analysis.
Results At 28 days and 91 days after operation, there was no significant difference in lumen loss, neointimal area, inflammation score and endothelialization score among the experimental groups. The degree of endothelialization was better than that of the EXCEL group; 182 days after operation, the Co-P-SES group and the EXCEL group had no significant difference in lumen loss, inflammation score and endothelialization score, but the surrounding area of the internal elastic plate was similar. Under normal circumstances, the lumen area of the Co-P-SES group was larger than that of the EXCEL group [(4.31±0.94)mm2 vs (2.62±1.17)mm2, P=0.020)], and the neointimal area was smaller than that of the EXCEL group [(1.87±0.53) mm2 ratio (0.84±0.41)mm2, P=0.004)], the difference was statistically significant.
meaning.
Conclusion In the mini-pig coronary artery hyperdilation model, the safety of Co-P-SES is similar to that of EXCEL, and it may have certain advantages in endothelialization and reduction of neointimal formation. Further clinical studies are necessary to better evaluate its safety. sex and effectiveness.
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