TCT-813 A Novel Method for Evaluation of Polymer Absorption from Sirolimus Eluting Stent and its Influence on Biological Effects

Orlik, Bartłomiej; Buszman, Piotr P.; Kasperczyk, Janusz; Janas, Adam; Jelonek, Michał; Krauze, Agata; Samborski, Stefan; Gorycki, Bogdan; Wojakowski, Wojciech; Pawel, Buszman E.; Milewski, Krzysztof

doi:10.1016/j.jacc.2013.08.1566

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“…The elevated dose (1.3 μg/mm 2 ) stent is compared with a regular dose (1 μg/mm 2 ) reference stent, which both release 95% of the drug within three months from a biodegradable polymer platform in vivo [8]. Structurally identical BMS served as a control.…”

Section: Discussionmentioning

confidence: 99%

“…Experimental studies in the porcine in-stent restenosis model at eight weeks showed nearly full polymer biodegradation and 95% drug release of initial drug load (Fig. 1) [8]. The studied, elevated dose SES (ed-frSES, Alex, Batlon, Poland) employs sirolimus at 1.3 μg/mm 2 , whereas the reference stent was at a regular dose of 1 μg/mm 2 (frSES, regular dose, fast releasing sirolimus eluting stent).…”

Section: Device Descriptionmentioning

confidence: 95%

“…Early generation zotarolimus eluting stent (ZES), with fast release kinetics provided superior safety, with very low risk of stent thrombosis; however, the efficacy in restenosis inhibition was inferior when compared to slow-release ZES [7]. In our recent experiments we tested the pharmacokinetics of a fast-release, regular dose (1 μg/mm 2 ) sirolimus and biodegradable polymer cobalt chromium stent (FR-SES), which has shown 95% of drug elution within 90 days in an in-vivo setting and complete healing at 30 days [8]; however, the efficacy was limited, similarly to previously cited reports on ZES. In the current study we test the hypothesis that sirolimus dose increase, as well as release kinetics, may influence the vascular healing response.…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2015

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A b s t r a c tBackground: 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 μg/mm 2 of sirolimus, eight frSES with 1 μg/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.

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Section: Discussionmentioning

confidence: 99%

Section: Device Descriptionmentioning

confidence: 95%