Data Published in December Issue of Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine 

HONG KONG,  OrbusNeich today reported clinical data showing that the Genous Stent is a feasible and safe option for the treatment of bifurcation lesions, with no incidence of late stent thrombosis (ST) and a very low rate of repeat revascularization reported at one year. The data were published in the December issue of Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine.

In the prospective, controlled registry, a total of 43 consecutive patients with 47 consecutive bifurcation lesions were treated with OrbusNeich’s endothelial progenitor cell (EPC) capturing Genous Stent. The rate of binary restenosis inside the stent, the study’s angiographic endpoint, was 5 percent, with rates of 2.1 percent in the main branch (MB) and 10.5 percent in the side branch (SB). The mean late lumen loss was 0.31 ± 0.4 mm in the MB and 0.4 ± 0.39 in the SB. No in-hospital, 30-day or 12-month major adverse cardiac events (MACE) were reported.

“Bifurcation lesions remain a challenge because they are prone to higher rates of restenosis and poor immediate outcomes,” said Andrea Rognoni, M.D., of the Azienda Ospedaliero-Universitaria “Maggiore della Carità” di Novara, Italy, and first author of the study. “While drug eluting stents (DES) have improved outcomes in the bifurcation setting, they are still associated with a small but statistically significant increase in late and very late thrombosis. These data show that, in addition to good clinical and angiographic results, the use of Genous resulted in no late stent thrombosis at one-year follow-up. As a result, we believe that Genous is a feasible and safe alternative to DES in this high-risk scenario. We are also planning to report four-year follow-up data from this study early in 2012.”

Patients eligible for the study included those with stable or unstable angina pectoris, non-ST elevation myocardial infarction, silent ischemia and de novo coronary bifurcations lesions. Of the coronary bifurcations treated, 24 involved the left anterior descendent – diagonal branch bifurcation, 17 involved the left circumflex-obtuse marginal branch and six involved the posterior descendent artery-posterior lateral. All parameters were calculated five mm proximal and distal to the stented segments, with angiographic follow-up performed seven to eight months after PCI using the CMS-Medis Medical Imaging System.

Source: OrbusNeich