Evaluation of a novel fully bioresorbable poly-L-Lactic acid/amorphous calcium phosphate scaffolds in porcine coronary arteries by quantitative coronary angiography and histopathology

Background: Sirolimus-eluting coronary stents (SES) reduced rates of restenosis but also raised clinical adverse events caused by metallic platform. The novel bioresorbable vascular scaffolds (BVS) can degrade its platform completely after 2-3 years in vivo may overcome the limitations of SES. This study was sought to evaluate the efficacy and safety of the BVS. Methods: 48 stents (BVS n = 24, SES n = 24) were randomly implanted in 24 pigs. Quantitative coronary angiography (QCA) and histopathologic analysis were performed at 14 days, 28 days, 90 days and 180 days follow-up. Results: There was no evidence of stent thrombosis in two groups. The lumen loss (LL) and area stenosis of BVS group were slightly higher than SES group (P > 0.05), whereas the neointimal area was smaller (P > 0.05) at 14 days. Compared to SES group, the LL, neointimal area and area stenosis of BVS group showed a slightly decreased tendency without statistical difference at 28 days and 90 days. At 180 days, the LL of BVS group was numerically smaller than SES group (P = NS). Notably, significantly reduced of neointimal area and area stenosis were observed in BVS group (1.13 +/- 0.23 mm(2) vs. 2.29 +/- 0.91 mm(2), P = 0.013 and 31.13 +/- 4.59% vs. 51.46 +/- 10.61%, P = 0.002, respectively). In histopathologic analysis, there were no significant differences in inflammation score, injury score and endothelialization score between two groups. Conclusions: The novel BVS showed similar safety profile compared with SES, whereas may provide potential advantage in the long-term inhibition of neointimal proliferation.TT Medical, Inc.SCI(E)ARTICLE23131-31381