Healing score of the Xinsorb scaffold in the treatment of de novo lesions: 6-month imaging outcomes.

The objectives of this study are to assess the healing score (HS) and neointimal thickness of the Xinsorb scaffold, and explore the relationships between the implanted patterns, neointimal thickness, and HS. The Xinsorb bioresorbable sirolimus-eluting scaffold is the first domestically designed and fabricated bioresorbable scaffold in China. The 6-month follow-up found it to be safe and effective in the treatment of single de novo coronary lesions. The Xinsorb scaffolds were implanted in 30 patients with symptomatic ischemic coronary disease. A 6-month follow-up was performed in a subset of 19 patients; the HS and neointimal thickness were evaluated by optical coherence tomography. Struts were classified as ApposedCovered, ApposedUncovered, MalapposedCovered, MalapposedUncovered, jailing and presence of intraluminal masses. The implanted pressure, implanted duration, and post-expansion pressure were recorded during the operation. We evaluated the relationship between the HS or neointimal thickness and the implanted pressure, holding time, and post-expansion pressure. The device and procedure success rates were both 100%. No major adverse cardiac or scaffold-thrombus related events occurred. At 6 months, 12,295 struts were analyzed to determine the HS (6.23) and neointimal thickness (0.1021 ± 0.05718 mm) in the Xinsorb scaffolds. There was a strong negative relationship between the HS and the implantation duration (Pearson r = - 0.518, p = 0.023). A significant negative relationship also existed between the HS and post-dilatation (Pearson r = - 0.631, p = 0.004). The Xinsorb scaffold HS appears negative correlated with the implanted duration and post-dilatation. We will further evaluate the HS of randomized controlled trial of the Xissorb scaffold.

RCT Entities:   Population Interventions Outcomes