Cre8™ coronary stent: preclinical in vivo assessment of a new generation polymer-free DES with Amphilimus™ formulation

This new generation of DES has attempted to improve clinical safety by avoiding the presence of polymers. The present preclinical in vivo study was designed to investigate the safety profile of Cre8™ stent. This is a new coronary stent based on Amphilimus™, a sirolimus formulated with a polymer-free...

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Bibliographic Details
Published in:	EuroIntervention Vol. 7; no. 9; pp. 1087 - 1094
Main Authors:	MORETTI, Claudio, LOLLI, Vasco, PERONA, Giovanni, VIGNOLINI, Maria-Cristina, CABIALE, Karine, FALZONE, Mimmo, GALLONI, Marco
Format:	Journal Article
Language:	English
Published:	Toulouse Société Europa Edition 2012
Subjects:	Animals Biological and medical sciences Cardiology. Vascular system Coronary Angiography Coronary heart disease Coronary Vessels - pathology Drug-Eluting Stents - adverse effects General aspects. Genetic counseling Heart Incidence Inflammation - epidemiology Inflammation - etiology Medical genetics Medical sciences Models, Animal Neointima - epidemiology Neointima - etiology Polymers Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Sirolimus Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Swine Time Factors Antineoplastic agent Animal model Sirolimus carbon coating Cardiovascular disease Asymptomatic Coatings Stent Macrocycle Design Formulation Protein synthesis inhibitor Carrier Endoprosthesis cobalt-chromium stent Control release polymer polymer-free carrier Coronary artery Instrumentation therapy Lactone Macrolide Carbon Coronary heart disease Genetic disease In vivo Antibiotic Generation Genetic counseling DES Chromium Dosage form Coating Immunosuppressive agent stent design
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Summary:	This new generation of DES has attempted to improve clinical safety by avoiding the presence of polymers. The present preclinical in vivo study was designed to investigate the safety profile of Cre8™ stent. This is a new coronary stent based on Amphilimus™, a sirolimus formulated with a polymer-free amphiphilic carrier released from reservoirs machined onto the abluminal stent surface. Cre8™ stents were compared with two controls: R3 (the same platform only loaded with an amphiphilic carrier) and the Cypher Select Plus® stent (Cordis, Johnson & Johnson, Warren, NJ, USA). All devices (48 stents) were implanted in porcine coronary arteries with subsequent histological and morphometric evaluations at seven, 30 and 90 days. Early endothelisation at seven days was almost complete in all stents. Vessel wall histology at 30 days demonstrated a mild inflammation score in all groups (an inflammation score lower than 1 was observed in 100% of Cre8 stent, 71.5% for R3 and 66.7% for Cypher; p=n.s.) while morphometry showed a significantly smaller neointimal area in Cre8™ (Cre8 0.93±0.43 mm2; R3 1.49±0.67 mm2; Cypher 1.81±0.94 mm2; Cre8 vs. Cypher p<0.05); this difference was maintained after 90 days (inflammation score lower than 1 in 100% of Cre8 stent, 100% for R3 and 66.7% for Cypher; p=n.s. Neointimal area was 1.27±0.56 mm2 for Cre8, 1.74±0.60 mm2 for R3 and 2.79±1.14 mm2 for Cypher; Cre8 and R3 vs. Cypher p<0.05 while neointimal thickness was 0.15±0.07 mm for Cre8, 0.21±0.12 mm for R3 and 0.31±0.15 mm for Cypher; Cre8 vs. Cypher p<0.05). The most significant experimental evidence appears to be the absence of chronic inflammatory response in Cre8™ stent. This is expressed by a reduced neointimal thickness and inflammatory score at all follow-ups. Such an outcome positively compares with the other DES where a trend to neointimal growth and increased cell infiltration was observed.
ISSN:	1774-024X 1969-6213
DOI:	10.4244/EIJV7I9A173