Evaluation of the efficacy and safety of a stent covered with biosynthetic cellulose in a rabbit iliac artery model.

Objectives: We sought to test the efficacy and safety of the implantation of a stent covered with biosynthetic cellulose compared to a conventional bare-metal stent (BMS) in a rabbit iliac artery model.

Background: Biosynthetic cellulose is a biocompatible film used in several fields of medicine. Stents covered with biosynthetic cellulose are devices with the potential of achieving total lesion coverage, acting as a physical barrier to the migration of smooth muscle cells from the artery wall to the arterial lumen, and capturing circulating endothelial progenitor cells that may form a functional endothelial layer.

Methods And Results: Seven BMS and 7 stents covered with biosynthetic cellulose were implanted in the iliac arteries of 7 rabbits. Angiographic restudy and morphometric analysis of the specimens were performed after 4 weeks. No intrastent angiographic restenosis was observed, either with BMS or with stents covered with biosynthetic cellulose. There was also no acute or late vessel occlusion caused by stent thrombosis in either group. In the BMS and biosynthetic cellulose stented groups, respectively, mean neointimal thicknesses were 0.18 +/- 0.02 mm and 0.35 +/- 0.02 mm*; lumen area, 4.6 +/- 0.43 mm2 and 4.04 +/- 0.42 mm2; neointimal area, 0.58 +/- 0.09 mm2 and 2.13 +/- 0.11 mm(2)*; % lumen, 79.09 +/- 1.6% and 58.44 +/- 3.26%*; % stenosis, 10.97 +/- 1.23% and 35.55 +/- 3.39%* (*p < 0.05 vs. bare-metal).

Conclusions: Implantation of stents covered with biosynthetic cellulose was safe, with no acute or late vessel occlusion caused by stent thrombosis, although it resulted in a more pronounced absolute neointimal thickness when compared to BMS.