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

A new coronary stent based on Amphilimus™ which is Sirolimus formulated with a polymer-free amphiphilic carrier released from reservoirs machined on the abluminal stent surface was compared with two controls: R3 (same platform only loaded with amphiphilic carrier) and Cypher Select Plus stent. 48 stents were implanted in porcine coronary arteries with subsequent histological and morphometric evaluations at 7, 30 and 90 days. Early endothelization at 7 days resulted almost complete in all stents. Vessel wall histology at 30 days demonstrated a mild inflammation score in all groups, while morphometry showed a significantly thinner neointimal area in Cre8. Such outcome positively compares with the other DES where a trend to neointimal growth and increased cell infiltration was observed.