Key result
Polymer-free FK506-eluting stents significantly reduced neointimal thickness, area, and percent stenosis at 30 and 90 days compared with controls, but this effect was not sustained at 180 days.
Why the study?
Does a polymer-free tacrolimus-eluting stent reduce neointimal hyperplasia compared to control stents in a porcine coronary model?
Does a polymer-free tacrolimus-eluting stent reduce neointimal hyperplasia compared to control stents in a porcine coronary model?
A polymer-free tacrolimus-eluting stent reduces neointimal hyperplasia at 30 and 90 days in a porcine model, but this effect is not sustained at 180 days.
Transient neointimal suppression in porcine model; leaves open durability of polymer-free tacrolimus-eluting stents for clinical translation.
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 microg/mm(2)) n = 44; FK506 (2.6 microg/mm(2)) 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.
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Prunotto et al. (2008) studied Porcine coronary artery model (n=78). Polymer-free FK506 drug-eluting stent vs. Control stents was evaluated on Acute and chronic tissue response (neointimal thickness, neointimal area, and % stenosis). Polymer-free FK506-eluting stents significantly reduced neointimal thickness, area, and percent stenosis at 30 and 90 days compared with controls, but this effect was not sustained at 180 days.
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