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Shen L.,Fudan University | Wang Q.,Fudan University | Wu Y.,Fudan University | Hu X.,Shandong Huaan Biotechnology Co. | And 2 more authors.
Polymer Bulletin | Year: 2012

Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. In this report, short-term effects of fully bioabsorbable sirolimus-loaded poly-L-lactic acid (PLLA) stents (Xinsorb) were evaluated in a porcine coronary model. Commercially available PLLA-coated sirolimus-eluting stents (Excel) were used as controls. The purpose of this study was to assess technical feasibility, biocompatibility, and impact on coronary stenosis of fully bioabsorbable PLLA stents. Our preliminary experience suggested that Xinsorb stents have succeeded in preventing elastic recoil and suppressing neointimal formation for the first 90 days and only mildly delayed the endothelialisation process of the stented blood vessel. Coronary stenosis following Xinsorb and Excel stent implantations after 30 and 90 days was 18.6 ± 5.2% versus 21.4 ± 7.2% and 24.5 ± 4.7% versus 27.7 ± 5.6%, respectively (p>0.05). Both Xinsorb and Excel stents required approximately 1-3 months for re-endothelialization of the inner wall of stented blood vessels. These data provided additional insights into the mechanism and efficacy of fully bioabsorbable PLLA stents in normal porcine coronary arteries while raising questions regarding the potential durability of this novel medical device. Long-term follow-up will be required to validate the long-term efficacy of fully bioabsorbable PLLA stents. © Springer-Verlag 2011.

Wu Y.-Z.,Fudan University | Shen L.,Fudan University | Wang Q.-B.,Fudan University | Hu X.,Shandong Huaan Biotechnology Co. | And 3 more authors.
Chinese Medical Journal | Year: 2012

Background First generation drug-eluting stents (DESs) were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice. Methods Cobalt chromium based DES with bioabsorbable polymer (Simrex stent) as well as control stents (Polymer stent and EXCEL TM stent) were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography (QCA) analysis, histomorphometry, and electron-microscopical follow-up were performed. Results A total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis (%DS), late loss (LL), and percent area stenosis (%AS) of Simrex was (12.9±0.4)%, (0.35±0.02) mm, and (24.5±4.2)%, respectively, without significant difference in comparison to commercialized EXCEL TM stent. Slight inflammatory reaction was seenaround the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4-12 weeks for Simrex to complete its re-endothelialization process. Conclusions Cobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.

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