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

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 mu m) 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.

Automated summary

This study investigated the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold. The results showed that the efficacy and safety of the nitrided iron scaffold were comparable with those of the Vision stent within 52 weeks after implantation. Furthermore, a large number of struts were almost completely absorbed in situ at 7 years follow-up.