Dose-dependent vascular response following delivery of sirolimus via fast releasing, biodegradable polymer stent matrix: an experimental study in the porcine coronary model of restenosis

作者：Buszman Piotr P; Orlik Bartlomiej; Pajak Jacek; Jelonek Michal; Krauze Agata; Janas Adam; Legutko Jacek; Wojakowski Wojciech; Buszman Pawel E; Milewski Krzysztof

来源：Kardiologia Polska, 2015, 73(10): 916-923.

DOI：10.5603/KP.a2015.0085

• sirolimus eluting stent
• fast release
• biodegradable polymer
• porcine coronary model

Background: Fast releasing, rapamycin-eluting stents, although safe, showed inferior results with regard to inhibition of restenosis. Aim: Therefore, we report vascular effects of a novel, biodegradable polymer stent matrix with elevated sirolimus dose and fast release kinetics (ed-frSES, Alex, Balton) in the porcine coronary in-stent restenosis model.
Methods: A total of 19 stents were implanted with 120% overstretch in the coronary arteries of seven domestic pigs: seven ed-frSES with 1.3 mu g/mm(2) of sirolimus, eight frSES with 1 mu g/mm(2) of sirolimus, and eight bare metal stents (BMS). For the following 28 days, coronary angiography was performed, animals were sacrificed, and the stented segments harvested for histopathological evaluation.
Results: In angiography at 28 days the late lumen loss was lowest in the elevated dose sirolimus eluting stent (SES) (ed-frSES: 0.20 +/- 0.2 vs. frSES: 0.80 +/- 0.5 vs. BMS: 0.96 +/- 0.5 mm, p < 0.01). This was confirmed in the morphometric evaluation in histopathology as represented by a significant and dose-dependent decrease in the percentage area of stenosis (ed-frSES: 22.4 +/- 12.7% vs. frSES: 35 +/- 10.7% vs. BMS: 47.5 +/- 12.5%, p < 0.01). There was no peri-strut inflammation in any of the groups. However, the endothelialisation score was numerically not meaningfully decreased in ed-frSES (ed-frSES: 2.93 vs. frSES: 3. vs. BMS: 3, p = 0.05). Signs of fibrin were also noted in ed-frSES (ed-frSES: 0.4 vs. frSES: 0 vs. BMS: 0, p = 0.05).
Conclusions: Sirolimus dose-dependent vascular response was reported. The elevated dose, fast releasing SES shows satisfactory vascular healing, similar to regular dose, fast release SES, with improved efficacy in restenosis inhibition.

• 出版日期2015