TY - JOUR
T1 - Efficacy and safety of pimecrolimus-eluting stents in porcine coronary arteries
AU - Waksman, Ron
AU - Pakala, Rajbabu
AU - Baffour, Richard
AU - Hellinga, David
AU - Seabron, Rufus
AU - Tio, Fermin O.
AU - Wittchow, Eric
AU - Tittelbach, Michael
AU - Diener, Tobias
AU - Harder, Claus
AU - Virmani, Renu
AU - Jones, Russel
PY - 2007/10
Y1 - 2007/10
N2 - Objective: We aimed to evaluate an effective dosage and safety profile of pimecrolimus as an anti-inflammatory drug for drug-eluting stents. Methods: In the dose finding study, coronary arteries of 20 domestic swine were randomly implanted with bare metal stents (ProKinetic and Guidant Vision), the ProKinetic stent with polylactic acid (PLLA), and pimecrolimus-eluting stents (32, 75, and 120 μg) over a period of 4 weeks. In addition, pimecrolimus (75 μg) and ProKinetic stents were randomly implanted into six swine over 3 months. In the safety study, the ProKinetic stent, the ProKinetic stent with PLLA, mid- (45 μg) and high-dose pimecrolimus (120 μg), and overlapping mid-dose stents were implanted over a period of 4 weeks. Mid-dose, ProKinetic stent, and ProKinetic stent with PLLA were implanted over a period of 3 months. Results: The dose finding study revealed excellent luminal patency with low percent occlusion (≈29% vs. ≈41%), injury (0.53-0.59 vs. 1.25), and inflammation (0.78-0.97 vs. 1.08) for the pimecrolimus group compared with the vision group. The safety study arm showed similar angiographic results for all tested groups, with a significantly larger minimal lumen diameter for pimecrolimus stents compared to PLLA stents. Except for the high-dose group and overlapping area of the overlapping group, promising morphometric results were found for pimecrolimus compared to bare metal stents. Conclusions: Present data suggest that pimecrolimus-eluting stents are safe and have a similar healing profile to bare metal stents. They may suppress inflammation, leading to a reduced intimal response and a milder inflammatory reaction in a porcine model.
AB - Objective: We aimed to evaluate an effective dosage and safety profile of pimecrolimus as an anti-inflammatory drug for drug-eluting stents. Methods: In the dose finding study, coronary arteries of 20 domestic swine were randomly implanted with bare metal stents (ProKinetic and Guidant Vision), the ProKinetic stent with polylactic acid (PLLA), and pimecrolimus-eluting stents (32, 75, and 120 μg) over a period of 4 weeks. In addition, pimecrolimus (75 μg) and ProKinetic stents were randomly implanted into six swine over 3 months. In the safety study, the ProKinetic stent, the ProKinetic stent with PLLA, mid- (45 μg) and high-dose pimecrolimus (120 μg), and overlapping mid-dose stents were implanted over a period of 4 weeks. Mid-dose, ProKinetic stent, and ProKinetic stent with PLLA were implanted over a period of 3 months. Results: The dose finding study revealed excellent luminal patency with low percent occlusion (≈29% vs. ≈41%), injury (0.53-0.59 vs. 1.25), and inflammation (0.78-0.97 vs. 1.08) for the pimecrolimus group compared with the vision group. The safety study arm showed similar angiographic results for all tested groups, with a significantly larger minimal lumen diameter for pimecrolimus stents compared to PLLA stents. Except for the high-dose group and overlapping area of the overlapping group, promising morphometric results were found for pimecrolimus compared to bare metal stents. Conclusions: Present data suggest that pimecrolimus-eluting stents are safe and have a similar healing profile to bare metal stents. They may suppress inflammation, leading to a reduced intimal response and a milder inflammatory reaction in a porcine model.
KW - In-stent restenosis
KW - Pimecrolimus-eluting stent
KW - Porcine
UR - http://www.scopus.com/inward/record.url?scp=36348986263&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=36348986263&partnerID=8YFLogxK
U2 - 10.1016/j.carrev.2007.09.003
DO - 10.1016/j.carrev.2007.09.003
M3 - Article
C2 - 18053948
AN - SCOPUS:36348986263
SN - 1553-8389
VL - 8
SP - 259
EP - 274
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
IS - 4
ER -