Safety and Efficacy of OrbusNeich’s Genousâ„¢ Stent Demonstrated in High-Risk Patients with Known Contraindications for Dual Antiplatelet Therapy

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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