Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery

oleh: Jian-Feng Zheng, Zi-Wei Xi, Yang Li, Jia-Nan Li, Hong Qiu, Xiao-Ying Hu, Tong Luo, Chao Wu, Xin Wang, Lai-Feng Song, Li Li, Hai-Ping Qi, Gui Zhang, Li Qin, Wan-Qian Zhang, Xiao-Li Shi, Shu-Han Wang, De-Yuan Zhang, Bo Xu, Run-Lin Gao

Format: Article
Diterbitkan: KeAi Communications Co., Ltd. 2022-11-01

Deskripsi

This study aimed to investigate the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold (BRS) in vivo, encompassing the whole process of bioresorption in porcine coronary arteries. Fifty-two nitrided iron scaffolds (strut thickness of 70 μm) and 28 Vision Co–Cr stents were randomly implanted into coronary arteries of healthy mini-swine. The efficacy and safety of the nitrided iron scaffold were comparable with those of the Vision stentwithin 52 weeks after implantation. In addition, the long-term biocompatibility, safety, and bioresorption of the nitrided iron scaffold were evaluated by coronary angiography, optical coherence tomography, micro-computed tomography, scanning electron microscopy, energy dispersive spectrometry and histopathological evaluations at 4, 12, 26, 52 weeks and even at 7 years after implantation. In particular, a large number of struts were almost completely absorbed in situ at 7 years follow-up, which were first illustrated in this study. The lymphatic drainage pathway might serve as the potential clearance way of iron and its corrosion products.