OrbusNeich announced that the company’s Genous stent provides the most rapid healing of the coronary vessel compared with bare metal stents and drug-eluting stents (DES) at 14 days post-implantation. The data were presented by Ladislav Groch, University Hospital St Anna, Brno, Czech Republic, in the at the 23th annual Transcatheter Cardiovascular Therapeutics (TCT) symposium in San Francisco.
The prospective, single-centre, randomised study compared the endothelial stent coverage of the Blazer cobalt chromium stent (OrbusNeich), the cobalt chromium SolarFlex stent (Disa Vascular) and the biolimus eluting coronary stainless steel Nobori stent (Terumo) with the Genous stent, measuring optical coherence tomography at 14 days. The percentage of healed struts—a proxy for endothelial coverage, the most powerful predictor of stent thrombosis—was significantly higher in the Genous stent compared to the analysed cobalt chromium stents and the drug-eluting stents. Specifically, the Genous stent had 69.7% healed and 5.3% malapposed struts compared to 56.7% healed and 19.7% malapposed struts for the Blazer stent, 55.2% healed and 13.9% malapposed struts for the SolarFlex stent and 34% healed and 45.7% malapposed struts for the Nobori stent.
“These data confirm that the endothelial progenitor cell-capturing Genous stent accelerates the healing of the coronary vessel wall following percutaneous coronary intervention relative to bare metal stents and drug-eluting stents,” said Groch. “Early healing is a powerful predictor of subacute and late stent thrombosis, and the high percentage of covered struts seen with the Genous stent potentially minimises the length of dual antiplatelet therapy. This is especially important for patients with an increased risk for bleeding.”
The primary endpoint of the study was the percentage of covered struts. Secondary endpoints were the percentage of malapposed struts and the absolute thickness of neointima. The study included 40 patients with stable or unstable angina or non-sustained myocardial infarction who underwent percutaneous coronary intervention with stent implantation; a total of 44 stents were implanted. The patients were randomised into four groups with 10 patients per group, and a total of 4413 stent struts were analysed manually.