Preclinical Results Promising for Combo Stent

SAN FRANCISCO, CALIF.—Preclinical results indicate that the safety profile of current DES technologies can be enhanced by new technologies that attract endothelial progenitor cells (EPCs) to promote accelerated healing of the vessel wall following stent implantation.

In the prospective, randomized REMEDEE trial, which evaluated in-stent late lumen loss at 9 months in patients with ischemic heart disease, patients were randomized to either the Combo dual-therapy stent (OrbusNeich Medical) (n=120) or the paclitaxel-eluting Taxus Liberté stent (Boston Scientific) (n= 60), said Michael Haude, MD, from Lukaskrankenhaus Neuss in Germany, who is one of the principle investigators of the trial.

Overall, the Combo stent induced less neointima and improved endothelial coverage compared with the conventional PES.

Final data will be presented during a late-breaking session on Friday morning.

The Combo stent combines an abluminal biodegradable polymer matrix with patented EPC capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

Another ongoing study of the Combo device, REMEDEE OCT, is designed to determine rapid strut coverage at 60 days, the study’s primary endpoint, with the use of optical coherence tomography. Patients with ACS (STEMI and non-STEMI) are being enrolled; 30 will receive the Combo stent and 30 will receive an everolimus-eluting stent (Xience V, Abbott Vascular).

For REMEDEE, major inclusion criteria included the presence of single de novo lesions in native coronary arteries; lesion length of 20 mm or less; and reference vessel diameter of 2.5 mm to 3.5 mm. Patients were excluded if they had acute MI, ostial lesions or unprotected left main with at least 50% stenosis.