Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: results from porcine coronary artery model

The optimal treatment strategy for coronary bifurcation lesions is still unknown. The BiOSS Lim stents (Bifurcation Optimisation Stent System) is a novel dedicated bifurcation stent introduced over a single wire in to the main vessel, covered with biodegradable polymer and sirolimus. It has wider proximal and narrower distal parts. The aim of the study was to assess applicability of the the BiOSS Lim stent in a porcine coronary model.

A total of 14 BiOSS Lims were implanted in normal non-atherosclerotic porcine coronary bifurcations of 14 animals (six stents for 28 days, eight stents for 90 days) using 1.1:1.0 stent-to-artery ratio. Stent geometry and morphology were evaluated by Faxitron imagery (Faxitron Bioptics, LLC, IL, USA). Vascular effects were assessed based on angiographic and histological analysis. Analysis of Faxitron images revealed no major abnormalities except two struts fractures at the place of connection between the mid-portion and proximal wider part of the stent. Histomorphometry showed decreased area stenosis and intimal thickness at 90 days compared with the 28 days cohort. The inflammatory scores were low (<1) at both time points and struts endothelialisation was completed at 28 days.

The novel BiOSS Lim stent demonstrates good short- and mid-term vascular effects in a porcine coronary bifurcation model.