Long-term efficacy,safety and biocompatibility of a novel sirolimus eluting iron bioresorbable scaffold in a porcine model  

作　　者：Ya-Nan Gao Hong-Tao Yang Zi-Feng Qiu Feng Qi Qian-Hong Lu Jian-Feng Zheng Zi-Wei Xi Xin Wang Li Li Gui Zhang De-Yuan Zhang Yu-Die Lu Hai-Ping Qi Hong Qiu Run-Lin Gao Yu-Feng Zheng 

机构地区：[1]Department of Cardio-Metabolic Medicine Center,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,China [2]Department of Cardiology,Coronary Artery Disease Center,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,China [3]Beijing Key Laboratory of Pre-clinical Research and Evaluation for Cardiovascular Implant Materials,Animal Experimental Center,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,China [4]Department of Pathology,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,China [5]School of Engineering Medicine,Beihang University,Beijing,China [6]R&D Center,Biotyx Medical(Shenzhen)Co.Ltd.,Shenzhen,China [7]Department of Cardiology,Fuwai Yunnan Hospital,Chinese Academy of Medical Sciences,Affiliated Cardiovascular Hospital of Kunming Medical University,Kunming,China [8]Peking University Health Science Center,Beijing,China [9]Department of Cardiology,Beijing Tsinghua Changgung Hospital,Beijing,China [10]Department of Cardiology,Beijing Anzhen Hospital,Capital Medical University,Beijing Institute of Heart Lung and Blood Vessel Diseases,Beijing,China [11]School of Materials Science and Engineering,Peking University,Beijing,China

出　　处：《Bioactive Materials》2024年第9期135-146,共12页生物活性材料（英文）

基　　金：supported by National Key R&D Program of China(grant number 2018YFC1106600);Shenzhen Industrial and Information Technology Bureau(20180309174916657);Science,Technology and Innovation Commission of Shenzhen Municipality(grant number GJHZ20180418190517302);Natural Science Foundation of China(grant number 52101282).

摘　　要：Iron is considered as an attractive alternative material for bioresorbable scaffolds(BRS).The sirolimus eluting iron bioresorbable scaffold(IBS),developed by Biotyx Medical(Shenzhen,China),is the only iron-based BRS with an ultrathin-wall design.The study aims to investigate the long-term efficacy,safety,biocompatibility,and lumen changes during the biodegradation process of the IBS in a porcine model.A total of 90 IBSs and 70 cobaltchromium everolimus eluting stents(EES)were randomly implanted into nonatherosclerotic coronary artery of healthy mini swine.The multimodality assessments including coronary angiography,optical coherence tomography,micro-computed tomography,magnetic resonance imaging,real-time polymerase chain reaction(PCR),and histopathological evaluations,were performed at different time points.There was no statistical difference in area stenosis between IBS group and EES group at 6 months,1year,2 years and 5 years.Although the scaffolded vessels narrowed at 9 months,expansive remodeling with increased mean lumen area was found at 3 and 5 years.The IBS struts remained intact at 6 months,and the corrosion was detectable at 9 months.At 5 years,the iron struts were completely degraded and absorbed in situ,without in-scaffold restenosis or thrombosis,lumen collapse,aneurysm formation,and chronic inflammation.No local or systemic toxicity and abnormal histopathologic manifestation were found in all experiments.Results from real-time PCR indicated that no sign of iron overload was reported in scaffolded segments.Therefore,the IBS shows comparable efficacy,safety,and biocompatibility with EES,and late lumen enlargement is considered as a unique feature in the IBS-implanted vessels.

关 键 词：Bioresorbable scaffold Sirolimus eluting iron bioresorbable scaffold Preclinical study Completely bioresorbable Late lumen enlargement 

分 类 号：R318[医药卫生—生物医学工程]