Clinical and Industry News

Data Show OrbusNeich’s Genous™ Bio-engineered R Stent™ Has Better Outcomes When Compared to Drug-Eluting Stents

OrbusNeich announced that data presented recently at the 17th Annual Meeting of the Japanese Society of Interventional Cardiology (July 3-5, 2008, Nagoya, Aichi, Japan) demonstrate that the Genou s Bio-engineered R stent has better outcomes when compared to drug-eluting stents. Presented by Federico Piscione, MD, the study’s principal investigator and a professor with the Federico II University of Naples’s Division of Cardiology, Department of Clinical Medicine and Cardiovascular Sciences, the data were generated following a study that involved 257 consecutive high-risk patients who underwent percutaneous coronary intervention (PCI) with either the Genous stent, or a Boston Scientific Taxus or Cordis Corporation Cypher stent at the university’s catheterization lab. At 13-months clinical follow-up, the cumulative major adverse cardiac events (MACE) rate for the Genous (GRS) group was 17.2% versus 26.4% for the combined Taxus and Cypher group (DES), a 35% reduction. For the MACE components: • Rate of myocardial infarction (MI) was 4.5% for GRS versus 6.8% for DES; • Rate of re-PCI was 7.5% for GRS and 13.5% for DES; • Cardiac death rate was 4.5% for GRS versus 7.4% for DES. • In addition, the rate for stent thrombosis was 0% for GRS versus 5.8% for DES. “Our results suggest that the Genous Bio-engineered R stent is safe and effective in high-risk patients,” said Piscione. “The results show a better long-term clinical outcome when compared with DES.” After PCI, patients who received GRS were prescribed dual anti-platelet therapy for one month, and patients who received DES were prescribed the same therapy for 12 months. A complete clinical follow-up was obtained in 100% of GRS patients vs. 96% of DES patients. Additionally, 22 consecutive patients requiring “life-saving,” non-deferrable major noncardiac surgery (NCS) or endovascular aortic repair (EVAR), underwent coronary angiography for clinical or instrumental signs of ischemia before NCS or EVAR, and were treated with the Genous stent. Anti-platelet therapy was stopped five days prior to scheduled surgery in all patients, with an average anti-platelet therapy duration of 12.5 days. After NCS, thienopyridine administration was not restarted and 100 mg per day of ASA was the only cardiac anti-platelet therapy at discharge. MACE, including in-hospital cardiac death, MI, stent thrombosis, surgical bleeding complications, need for revascularization and 30-day after surgery clinical follow-up, were evaluated. The results of the study indicated an optimal acute procedural result in all patients. The 22 patients included in the study underwent uneventful NCS 10 to 22 days after coronary stent deployment. MACE rates were 0% at in-hospital follow-up and at one month follow-up. “The Genous stent may offer a new, important and feasible therapeutic strategy for patients needing to undergo life-saving or non-deferrable major non-cardiac surgery early after coronary stent deployment,” said Piscione. The Genous Bio-engineered R stent, an antibody-coated device, is the first stent to capture a patient’s endothelial progenitor cells (EPCs) to attempt to accelerate the natural healing process following placement. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous stent, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.