open access

Vol 27, No 2 (2020)
Original articles — Interventional cardiology
Published online: 2018-08-24
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Two-year longitudinal evaluation of a second-generation thin-strut sirolimus-eluting bioresorbable coronary scaffold with hybrid cell design in porcine coronary arteries

Pawel Gasior, Yanping Cheng, Jinggang Xia, Gerard B. Conditt, Jennifer C. McGregor, Renu Virmani, Juan F. Granada, Grzegorz L. Kaluza
DOI: 10.5603/CJ.a2018.0095
·
Pubmed: 30155861
·
Cardiol J 2020;27(2):115-125.

open access

Vol 27, No 2 (2020)
Original articles — Interventional cardiology
Published online: 2018-08-24

Abstract

Background: The first commercially available bioresorbable scaffold (BRS) had a strut thickness of 156 microns. As such, it had the potential for delivery challenges and higher thrombogenicity. The aim herein, is to evaluate biomechanical performance, pharmacokinetics and vascular healing of a novel thin strut (100 μm) sirolimus eluting BRS (MeRes-100, Meril Life Sciences, Gujarat, India) against the once clinically used BRS (Absorb BVS, Abbott, Santa Clara, CA) in porcine coronary arteries.

Methods: Following device implantation, angiographic and optical coherence tomography (OCT) evaluation were performed at 45, 90, 180 days, 1 year and 2 years. Histological evaluation was per­formed at 30, 90 and 180 days.

Results: At 2 years, both lumen (MeRes-100 7.07 ± 1.82 mm2 vs. Absorb BVS 7.57 ± 1.39 mm2, p = NS) and scaffold areas (MeRes-100 9.73 ± 1.80 mm2 vs. Absorb BVS 9.67 ± 1.25 mm2, p = NS) were comparable between tested and control scaffolds. Also, the late lumen area gain at 2 years was similar in both groups tested (MeRes-100 1.03 ± 1.98 mm2 vs. Absorb BVS 0.85 ± 1.56 mm2, p = NS). Histologic examination up to 6 months showed comparable healing and inflammation profiles for both devices.

Conclusions: The novel sirolimus-eluting BRS with thinner struts and hybrid cell design showed similar biomechanical durability and equivalent inhibition of neointimal proliferation when compared to the first-ever Absorb BVS up to 2 years in normal porcine coronary arteries.

Abstract

Background: The first commercially available bioresorbable scaffold (BRS) had a strut thickness of 156 microns. As such, it had the potential for delivery challenges and higher thrombogenicity. The aim herein, is to evaluate biomechanical performance, pharmacokinetics and vascular healing of a novel thin strut (100 μm) sirolimus eluting BRS (MeRes-100, Meril Life Sciences, Gujarat, India) against the once clinically used BRS (Absorb BVS, Abbott, Santa Clara, CA) in porcine coronary arteries.

Methods: Following device implantation, angiographic and optical coherence tomography (OCT) evaluation were performed at 45, 90, 180 days, 1 year and 2 years. Histological evaluation was per­formed at 30, 90 and 180 days.

Results: At 2 years, both lumen (MeRes-100 7.07 ± 1.82 mm2 vs. Absorb BVS 7.57 ± 1.39 mm2, p = NS) and scaffold areas (MeRes-100 9.73 ± 1.80 mm2 vs. Absorb BVS 9.67 ± 1.25 mm2, p = NS) were comparable between tested and control scaffolds. Also, the late lumen area gain at 2 years was similar in both groups tested (MeRes-100 1.03 ± 1.98 mm2 vs. Absorb BVS 0.85 ± 1.56 mm2, p = NS). Histologic examination up to 6 months showed comparable healing and inflammation profiles for both devices.

Conclusions: The novel sirolimus-eluting BRS with thinner struts and hybrid cell design showed similar biomechanical durability and equivalent inhibition of neointimal proliferation when compared to the first-ever Absorb BVS up to 2 years in normal porcine coronary arteries.

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Keywords

optical coherence tomography, bioresobable scaffolds, histology

About this article
Title

Two-year longitudinal evaluation of a second-generation thin-strut sirolimus-eluting bioresorbable coronary scaffold with hybrid cell design in porcine coronary arteries

Journal

Cardiology Journal

Issue

Vol 27, No 2 (2020)

Pages

115-125

Published online

2018-08-24

DOI

10.5603/CJ.a2018.0095

Pubmed

30155861

Bibliographic record

Cardiol J 2020;27(2):115-125.

Keywords

optical coherence tomography
bioresobable scaffolds
histology

Authors

Pawel Gasior
Yanping Cheng
Jinggang Xia
Gerard B. Conditt
Jennifer C. McGregor
Renu Virmani
Juan F. Granada
Grzegorz L. Kaluza

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