WASHINGTON, Oct. 22 /PRNewswire/ -- The preliminary results of the first- ever randomized study to compare OrbusNeich's pro-healing stent, the Genous Bio-engineered R stent, with Boston Scientific's Taxus drug-eluting stent in high risk of restenosis patients show comparable efficacy at 30-day and six- month follow-up, reported Robbert de Winter, M.D., Ph.D., principal investigator and director of the catheterization laboratory at the Academic Medical Center in Amsterdam, at this year's Transcatheter Cardiovascular Therapeutics symposium, TCT 2007, in Washington, D.C.
Specifically, six-month clinical follow-up data from the 193-patient, single-center, prospective, single-blind study called TRIAS HR Pilot indicate:
-- No statistically significant difference in the rate of major adverse
cardiac events (MACE)
-- At six-month follow-up, the majority of patients who received a Genous
stent were on single antiplatelet therapy, while the majority of
patients who received a Taxus stent were still on dual antiplatelet
-- One acute stent thrombosis in the Genous arm, while there was one acute,
one subacute and one late stent thrombosis in the Taxus arm
-- More instances of non-target vessel revascularization (non-TVR) in the
"The much-needed alternative to drug-eluting stents may not be the next- generation drug-eluting stents," said de Winter. "Genous is a very promising, innovative device with a wide range of applications for physicians and many benefits to patients. The results of our pilot study fully support our rationale for the large-scale TRIAS study that will compare Genous to both drug-eluting and bare metal stents."
For the TRIAS HR Pilot, high risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 20 mm) and/or chronic total occlusions.
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.
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|SOURCE Academic Medical Center|
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