Biocompatibility of polyurethane-coated stents: tissue and vascular aspects.

To assess the arterial injury triggered by polyurethane-coated vs. uncoated stents, six polyurethane-coated and six bare nitinol stents were implanted in rabbit carotid arteries. All animals were sacrificed 4 wk after stent placement. Sections were evaluated by histology and morphometric analysis. At 4 wk, both the coated and uncoated stent struts were entirely endothelialized. The spaces between the struts showed a relatively mild proliferative response, with a few sections demonstrating neovascularization around the struts. Polyurethane coating was associated with an inflammatory tissue response consisting of lymphocytic infiltration and foreign-body reaction, with the appearance of multinucleated giant cells. Lumen, intimal, and medial cross-sectional areas varied little between coated and uncoated stented vessels (2.45+/-0.19 vs. 2.47+/-0.47 mm2, 1.17+/-0.52 vs. 0.78+/-0.30 mm2, and 0.66+/-0.18 vs. 0.58+/-0.27 mm2, respectively). In the rabbit carotid artery model, polyurethane coating does not affect the degree of neointimal proliferation after endovascular stenting compared with the conventional stenting approach. However, the inflammatory tissue response may indicate a low intrinsic biocompatibility of this stable polymer, so that it may not be an ideal material for coating intravascular devices.