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Safety and Efficacy of OrbusNeich's Genous™ Stent Demonstrated in High-Risk Patients with Known Contraindications for Dual Antiplatelet Therapy
Date:1/10/2011

HONG KONG, Jan. 10, 2011 /PRNewswire/ -- Data from patients who are considered high-risk due to underlying clinical conditions and who cannot be treated with drug eluting stents (DES) and the accompanying requirement of long-term dual antiplatelet therapy (DAPT) showed positive safety and short- and long-term clinical outcomes following treatment with OrbusNeich's Genous Stent, according to a study published online in EuroIntervention (published-ahead-of-print, August 2010).  

Known contraindications for DAPT include hypersensitivity or allergy to aspirin, a hemorrhagic risk, or a planned surgery shortly after percutaneous coronary intervention (PCI) that would require cessation of DAPT.

In the study, the major adverse cardiac events (MACE) free survival rate in patients treated with the Genous Stent was 80.6% after one year.  Between year one and year two, no additional MACE were observed. In patients who underwent surgical treatment shortly after PCI, no perioperative MACE or thrombotic events occurred.  Despite a very short period of DAPT use of 15 to 30 days, there were no cases of sub-acute, late or very late stent thrombosis in treated patients. The cumulative incidence of cardiac death was 1.6%, which is low considering the high risk patient population.

"The Genous Stent is an important and extremely attractive option for interventional cardiologists to safely manage high-risk patients who are contraindicated for prolonged DAPT and, therefore, should not receive a DES," said Paolo Scacciatella, M.D., Ph.D., of the Molinette Hospital Turin, Italy, and principal investigator of the study.  "This is the first study that demonstrates the feasibility and efficacy of the Genous Stent in this particular segment of patients who are challenging to treat."

Emanuele Meliga, M.D., Ph.D., FESC, of Ordine Mauriziano Hospital in Turin, Italy, and corresponding author of the publication added, "We have observe
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