Safety and histocompatibility of a novel biogradable stent implanted into the coronary artery in a porcine model

doi:10.3969/j.issn.2095-4344.2014.34.004

Abstract

Abstract:

BACKGROUND: In order to solve the problems of poly-l-lactic acid (PLLA) stents, such as poor support, acidic metabolites, we researched a novel biogradable stent-PLLA/amorphous calcium plosphate (ACP).

OBJECTIVE: To discuss the safety and histocompatibility of the novel biogradable stent-PLLA/ACP stent implanted in the coronary artery in a porcine model.

METHODS: Sixteen novel biogradable stents were randomly implanted into the coronary arteries, left anterior descending branch, left circumflex artery or right coronary artery of sixteen healthy Tibet miniature pigs. The blood routine and blood biochemistry were measured pre-operation and at 1 month after operation. The coronary blood vessels where the stent was implanted were examined by hematoxylin-eosin staining at 1 and 6 months after operation.

RESULTS AND CONCLUSION: Compared with pre-operation, the post-operation indicators of the blood routine and blood biochemistry were of no significant difference. Coronary angiography revealed coronary artery patency and no thrombosis, the vascular stent segments exhibited clear boundaries with the surrounding tissue, with no tissue adhesion, necrosis, and adherence abnormalities. The results of hematoxylin-eosin staining showed that there was no significant difference in vascular injury integral between 1 month after operation and 6 months after operation. However, 6 months after operation, the scores of the inflammation were lower (P < 0.05), and the scores of the endothelialization were increased (P < 0.05). There was no myocardial infarction and inflammatory cell infiltration around the stent. These results suggest that the novel biodegradable stent has good safety and histocompatibility.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

全文链接：

Key words: coronary vessels, calcium phosphates, histocompatibility

CLC Number:

R318

Lu Zhao, Jiang Xue-jun, Feng Gao-ke, Zheng Xiao-xin, Li Jun, Qin Chao-shi, Gu Wei-wang, Wang Qun, Xu Qing-ru, Huang Yi-mei, Chen Jiu-hao. Safety and histocompatibility of a novel biogradable stent implanted into the coronary artery in a porcine model[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(34): 5429-5433.

Figures/Tables 3

References

[1] 赵景新,刘惠亮,赵凤琴.药物洗脱支架的研究进展[J].中国实用医药,2007,2(31):136-138.
[2] Serruys PW,Ormiston JA,Onuma Y,et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373(9667):897-910.
[3] Ormiston JA, Serruys PW, Regar E,et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial.Lancet.2008;371(9616):899-907.
[4] Cutlip DE,Windecker S,Mehran R, et al.Clinical end points in coronary stent trials: a case for standardized definitions. Circulation.2007;115(17):2344-2351.
[5] CrossRef Onuma Y,Serruys PW,Ormiston JA,et al.Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010;6(4): 447-453.
[6] Joner M,Finn AV,Farb A,et al.Pathology of drug-eluting stents in humans:delayed healing and late thrombotic risk.J Am Coll Cardiol.2006;48:193-202.
[7] Onuma Y,Serruys PW,Gomez J,et al.Comparison of in vivo acute stent recoil between the bioresorbable everolimus-eluting coronary scaffolds(revision 1.0 and 1.1) and the metallic everolimus-eluting stent.Catheter Cardiovasc Interv.2011;78:3-12.
[8] Ormiston JA,Serruys PW,Onuma Y,et al.First Serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold:a multi-imaging modality study.Circ Cardiovasc Interv.2012;5:620-632.
[9] Ambrosio AM,Sahota JS,Khan Y,et al.A novel amorphous calcium phosphate polymer ceramic for bone repair: I. Synthesis and characterization.J Biomed Mater Res. 2001; 58(3):295-301.
[10] Linhart W,Peters F,Lehmann W,et al.Biologically and chemically optimized composites of carbonated apatite and polyglycolide as bone substitution materials. J Biomed Mater Res.2001;54(2):62-171.
[11] LanZ,LyuY,Xiao J,et al.Novel biodegradable drug-eluting stent composed of poly-L-lactic acid and amorphous calcium phosphate nanoparticles demonstrates improved structural and functional performance for coronary artery disease. J Biomed Nanotechnol.2014;10(7):1-11.
[12] Farb A,Heller PF,Shroff S,et al.Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation. 2001;104(4):473-479.
[13] Giannakakou P,Robey R,Fojo T,et al.Low concentrations of paclitaxel induce cell type-dependent p53,p21 and G1/G2 arrest instead of mitotic arrest:molecular determinants of paclitaxel- induced cytotoxicity. Oncogene. 2001;20(29): 3806-3813.
[14] Colombo A,Drzewiecki J,Banning A,et al.Randmized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for conronary artery lesions.Circulation.2003;108:788-794.
[15] Liistro F,Stankovic G,Di Mario C,et al.First clinical experience with a paclitaxel derivate-eluting polymer stent system implantation for instent restenosis:immediate and long-term clinical and angiographic outcome. Circulation. 2002;105: 1883-1886.
[16] Kaushal V,Schlichter LC.Mechanisms of microglia-mediated neurotoxicity in a new model of the stroke penumbra.J Neurosci.2008;28(9):2221-2230.
[17] Donato AJ,Black AD,Jablonski KL,et al. Aging is associated with greater nuclear NF κB, reduced Iκ Bα , and increased expression of proinflammatory cytokines in vascular endothelial cells ofhealthy humans. Aging Cell. 2008;7(6):805-812.
[18] 王新,李文杰.NF-κB与动脉粥样硬化的相关性及中药的干预作用[J].辽宁中医药大学学报,2009,11(3):55-56.