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 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.
Prunotto
M
M
Veterinary Morphophysiology Department, University of Turin, Italy - via Leonardo da Vinci 144, Grugliasco, Italy. marco.prunotto@gmail.com
Vignolini
C
C
Lolli
V
V
Black
A
A
Gaggianesi
S
S
Santarelli
A
A
Galloni
M
M
D015906:Angioplasty, Balloon, Coronary; D000818:Animals; D020099:Coated Materials, Biocompatible / Q000494:pharmacology*; D023903:Coronary Restenosis / Q000517:prevention & control; D003331:Coronary Vessels / Q000033:anatomy & histology / Q000187:drug effects*; D054855:Drug-Eluting Stents; D006965:Hyperplasia; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D008422:Materials Testing; D013499:Surface Properties; D013552:Swine; D013556:Swine, Miniature; D016559:Tacrolimus / Q000494:pharmacology*; D017539:Tunica Intima / Q000166:cytology / Q000187:drug effects* / Q000502:physiology
D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D016559:Tacrolimus