Short-, mid-, and long-term effects of a polymer-free tacrolimus-eluting stent in a porcine coronary model

Stent‐based delivery of tacrolimus has shown neointimal hyperplasia and restenosis reduction; FK506 is a water insoluble macrolide immunosuppressant. The purpose of this study was to evaluate acute and chronic tissue response to a polymer‐free FK506 drug‐eluting stent implantation in a porcine coronary artery model. Seventy‐eight nonatherosclerotic minipigs underwent successful placement of 134 stents (control n = 56; FK506 (1.5 μg/mm2) n = 44; FK506 (2.6 μg/mm2) n = 34) at 7, 15, 30, 90, or 180 days. Endothelialisation was almost complete at 7 days, complete at 15 days. At 30 and 90 days, mean neointimal thickness, neointimal area, and % stenosis was significantly less for drug‐eluting stents compared with controls. At 180 days, histomorphometric values were similar for eluting and control stents. The FK506‐eluting stent allows for a complete re‐endothelialisation at 15 days and favorably moderate neointimal hyperplasia at 30 and 90 days in the porcine coronary model. Because of a possible limited bioavailability of FK506, long‐term inhibition of neointimal formation was not sustained at the considered follow‐up. © 2008 Wiley Periodicals, Inc. J Biomed Mater Res, 2009