Evaluation of self-expandable, FK506-coated, covered stents in canine animal model.

This study aimed to evaluate whether drug coating of the recently developed covered SENDAI stents--self-expandable stents covered with segmented polyurethane (SPU) films--reduces neointimal thickening in animal model. FK506, which is one of the most effective immunosuppressants, was used. Bare stents; non-coated, covered stents; and FK506-coated, covered stents were placed bilaterally in the external iliac arteries of beagle dogs. After 1-month observation period, angiography did not show significant stent-induced stenosis. Histological evaluation revealed a completely endothelialized intravascular lumen and the absence of thrombus formation. The area of the intimal thickening induced by the FK506-coated stents was significantly smaller than that induced by the non-coated stents, whereas it was larger in the case of both the covered stents than that in the case of the bare stent. In conclusion, FK506 treatment of the self-expandable, covered stents was confirmed to effectively inhibit intimal thickening, although the SPU film used for covering functioned as a drug carrier in addition to a scaffold for intimal formation.