open access

Vol 23, No 6 (2016)
BASIC SCIENCE AND EXPERIMENTALNTAL CARDIOLOGY - ORIGINAL ARTICLES
Published online: 2016-12-14
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Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

Piotr P. Buszman, Magdalena J. Michalak, Maciej Pruski, Carlos Fernandez, Michał Jelonek, Adam Janas, Claudine Savard, Beata Gwiazdowska-Nowotka, Aleksander Żurakowski, Wojciech Wojakowski, Paweł E. Buszman, Krzysztof Milewski
DOI: 10.5603/CJ.2016.0108
·
Pubmed: 27976797
·
Cardiol J 2016;23(6):657-666.

open access

Vol 23, No 6 (2016)
BASIC SCIENCE AND EXPERIMENTALNTAL CARDIOLOGY - ORIGINAL ARTICLES
Published online: 2016-12-14

Abstract

Background: Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), however only limited preclinical data have been published. Therefore, we evaluate vascular response of a new generation biodegradable polymer SES (BP-SES: Alex Plus, Balton) and fluoropolymer EES (EES: Xience Pro, Abbott) in the porcine coronary restenosis model.
Methods: A total of 40 stents were implanted with 120% overstretch in coronaries of 17 domestic swine: 16 BP-SES, 16 EES and 8 bare metal controls (BMS). Following 28 and 90 days, coronary angiography and optical coherence tomography (OCT) was performed, animals sacrificed and stented segments harvested for pathological evaluation.
Results: At 28 days neointimal thickness in OCT was lowest in the BP-SES when compared to EES and BMS (0.18 ± 0.1 vs. 0.39 ± 0.1 vs. 0.34 ± 0.2 mm, respectively; p = 0.04). There was no difference in the proportion of malapposed or uncovered struts, although protruding covered struts were more common in BP-SES (14.8 ± 10% vs. 4.1 ± 4% vs. 3.7 ± 6%; p = 0.03). In pathology, the lowest neointimal thickness was confirmed in BP-SES (p < 0.05). The inflammation score was significantly lower in BP-SES and EES when compared to BMS (0.24 ± 0.1 vs. 0.4 ± 0.1 vs. 0.77 ± 0.4; p < 0.01) whilst EES and BP-SES had higher fibrin scores than BMS (1.2 ± 0.4 vs. 1.3 ± 0.3 vs. 0.17 ± 0.2; p < 0.01). At 90 days neointimal coverage and thickness in OCT was comparable between groups and healing in histopathology was complete.
Conclusions: New generation, BP-SES show similar vascular healing and biocompatibility profile with marginally higher degree of restenosis inhibition, when compared to fluoropolymer EES in the porcine coronary restenosis model.

Abstract

Background: Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), however only limited preclinical data have been published. Therefore, we evaluate vascular response of a new generation biodegradable polymer SES (BP-SES: Alex Plus, Balton) and fluoropolymer EES (EES: Xience Pro, Abbott) in the porcine coronary restenosis model.
Methods: A total of 40 stents were implanted with 120% overstretch in coronaries of 17 domestic swine: 16 BP-SES, 16 EES and 8 bare metal controls (BMS). Following 28 and 90 days, coronary angiography and optical coherence tomography (OCT) was performed, animals sacrificed and stented segments harvested for pathological evaluation.
Results: At 28 days neointimal thickness in OCT was lowest in the BP-SES when compared to EES and BMS (0.18 ± 0.1 vs. 0.39 ± 0.1 vs. 0.34 ± 0.2 mm, respectively; p = 0.04). There was no difference in the proportion of malapposed or uncovered struts, although protruding covered struts were more common in BP-SES (14.8 ± 10% vs. 4.1 ± 4% vs. 3.7 ± 6%; p = 0.03). In pathology, the lowest neointimal thickness was confirmed in BP-SES (p < 0.05). The inflammation score was significantly lower in BP-SES and EES when compared to BMS (0.24 ± 0.1 vs. 0.4 ± 0.1 vs. 0.77 ± 0.4; p < 0.01) whilst EES and BP-SES had higher fibrin scores than BMS (1.2 ± 0.4 vs. 1.3 ± 0.3 vs. 0.17 ± 0.2; p < 0.01). At 90 days neointimal coverage and thickness in OCT was comparable between groups and healing in histopathology was complete.
Conclusions: New generation, BP-SES show similar vascular healing and biocompatibility profile with marginally higher degree of restenosis inhibition, when compared to fluoropolymer EES in the porcine coronary restenosis model.

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Keywords

everolimus eluting stent; new generation sirolimus eluting stent; biodegradable polymer; porcine coronary restenosis model

Supplementary Files (2)
Supplementary figure 1. Bar charts featuring histopathological analysis of healing and biocompatibility at 90 day follow-up.
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Supplementary figure 2. Representative high power images of peri-strut magnifications
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About this article
Title

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

Journal

Cardiology Journal

Issue

Vol 23, No 6 (2016)

Pages

657-666

Published online

2016-12-14

DOI

10.5603/CJ.2016.0108

Pubmed

27976797

Bibliographic record

Cardiol J 2016;23(6):657-666.

Keywords

everolimus eluting stent
new generation sirolimus eluting stent
biodegradable polymer
porcine coronary restenosis model

Authors

Piotr P. Buszman
Magdalena J. Michalak
Maciej Pruski
Carlos Fernandez
Michał Jelonek
Adam Janas
Claudine Savard
Beata Gwiazdowska-Nowotka
Aleksander Żurakowski
Wojciech Wojakowski
Paweł E. Buszman
Krzysztof Milewski

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