Healthcare Industry News:  stent thrombosis 

Devices Interventional Cardiology

 News Release - January 10, 2008

OrbusNeich's Genous(TM) Bio-engineered R Stent(TM) has Lower MACE Rate than TAXUS(R) and CYPHER(R) Stents in Clinical Trial

NAPLES, Italy, Jan. 10 (HSMN NewsFeed) -- Patients who received OrbusNeich's pro-healing stent, the Genous Bio-engineered R stent, had significantly fewer major cardiac adverse events (MACE) than patients who received Boston Scientific's TAXUS or Johnson & Johnson's CYPHER drug-eluting stents in a study conducted at Federico II University of Naples in Naples, Italy. The results of the study were presented recently at the XXVIII National Congress of the Italian Society of Invasive Cardiology by Federico Piscione, M.D., the study's principal investigator and a professor with the university's Division of Cardiology, Department of Clinical Medicine and Cardiovascular Sciences.

At clinical follow-up of 10 months, the cumulative MACE rate for the Genous group (GRS) was 4% versus 22% for the combined TAXUS and CYPHER group (DES). For the MACE components, the cumulative rate of target vessel revascularization (TVR) was 1% for GRS versus 11.8% for DES, the cumulative rate of myocardial infarction (MI) was 1% for GRS versus 7.8% for DES, and the cumulative mortality rate was 2% for GRS versus 7.8% for DES. In addition, the cumulative rate for stent thrombosis was 2% for GRS versus 5.8% for DES.

"Our findings suggest that the deployment of Genous stents in a consecutive series of high-risk patients is safe and effective, with a significantly lower in-hospital incidence of MACE and a better long-term clinical outcome when compared to drug-eluting stents," said Piscione. "Genous is a viable alternative to drug-eluting stents, which have raised many safety concerns among the interventional cardiology community. Unlike TAXUS and CYPHER that elute cytotoxic agents to inhibit neointimal proliferation, Genous attracts circulating endothelial progenitor cells to rapidly build a layer of healthy tissue and promote long-term natural healing."

The study involved 195 consecutive high-risk patients who underwent percutaneous coronary intervention (PCI) with either GRS or DES implantation at the university's cath lab. After PCI, patients who received GRS were prescribed dual antiplatelet therapy for one month, and patients who received DES were prescribed the same therapy for nine months. Complete clinical follow-up was obtained for 100% of the patient population. High risk was defined as advanced age, high rate of conventional risk factors for CAD, multivessel disease, multivessel stenting, depressed left ventricular ejection fraction.

Genous is coated with an antibody to capture a patient's endothelial progenitor cells, and, therefore, accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis. The stent was developed by OrbusNeich, a global medical device company.

For more information about the study, call +390817462234 or send an e-mail to piscione@unina.it.


Source: Federico II University of Naples

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