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Two-Year Follow-Up Data Show Outstanding Clinical Outcomes and Safety for OrbusNeich’s Genousâ„¢ Stent in Patients at High Risk for Restenosis

August 16, 2011 By Bio-Medicine.Org

HONG KONG, Aug. 16, 2011 /PRNewswire/ — OrbusNeich today
announced that the that the company’s Genous Stent showed no
significant difference in the rate of target vessel failure (TVF)
at two years compared to the Taxus Liberte™
paclitaxel-eluting stent in patients with de novo coronary
artery lesions carrying a high risk for restenosis.  The
two-year follow-up data from the prospective, randomized TRIAS
pilot study were published in
Catheterization and Cardiovascular Interventions.

No cases of stent thrombosis (ST) were observed in patients
treated with the Genous Stent at two years, compared to five cases
of ST observed in four patients treated with Taxus. The cumulative
rate of cardiac death or myocardial infarction (MI) was 4.1 percent
in the Genous group compared to 6.3 percent in the Taxus group.

“It is noteworthy that we did not see any stent thrombosis in
patients with complex lesions treated with the Genous Stent,” said
Marcel Beijk, M.D., of the Academic Medical Center, Amsterdam, and
lead author of the paper. “We also saw that the Genous Stent tended
to have fewer episodes of target lesion revascularization between
one and two years.”

The single-center study investigated 193 patients of which 98
received a Genous Stent and 95 received a Taxus stent. Dual
antiplatelet therapy was prescribed for at least one month after
Genous Stent implantation and for at least six months after Taxus
stent implantation.

“For patients with a high risk of restenosis who cannot tolerate
the long-term dual antiplatelet therapy normally associated with
DES, it is clear that the Genous Stent is an excellent
alternative,” added Prof. Robbert de Winter, M.D., Ph.D., also of
the Academic Medical Center, Amsterdam, and an author of the
paper.

The study’s primary endpoint was TVF and secondary endpoints
included non-cardiac death, target lesion revascul

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SOURCE

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