Key result
The elevated dose, fast-releasing sirolimus eluting stent significantly reduced late lumen loss to 0.20 mm compared to 0.80 mm for the regular dose stent and 0.96 mm for bare metal stents at 28 days.
Why the study?
Does an elevated dose, fast-release sirolimus eluting stent reduce restenosis compared to regular dose sirolimus eluting stents and bare metal stents in a porcine coronary model?
Does an elevated dose, fast-release sirolimus eluting stent reduce restenosis compared to regular dose sirolimus eluting stents and bare metal stents in a porcine coronary model?
An elevated dose of sirolimus on a fast-releasing biodegradable polymer stent significantly reduces neointimal hyperplasia and late lumen loss compared to regular dose stents in a porcine model, while maintaining satisfactory vascular healing.
Supports dose optimization of fast-release sirolimus stents in preclinical models; leaves open translation to human restenosis prevention.
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 μg/mm2 of sirolimus, eight frSES with 1 μg/mm2 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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Buszman et al. (2015) studied Coronary in-stent restenosis (porcine model) (n=7). Elevated dose, fast-release sirolimus eluting stent (ed-frSES) vs. Regular dose fast-release sirolimus eluting stent (1 μg/mm2) and bare metal stents was evaluated on Late lumen loss at 28 days (p=<0.01). The elevated dose, fast-releasing sirolimus eluting stent significantly reduced late lumen loss to 0.20 mm compared to 0.80 mm for the regular dose stent and 0.96 mm for bare metal stents at 28 days.
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