Randomized TRIAS HR Pilot Study Compares Genous, Boston Scientific's
Taxus(R) Other Presentations Focus on Real-World Use of Genous, Stent's Performance
in Patients with AMI, Those Who Could Not Tolerate Dual-Antiplatelet
BARCELONA, Spain, May 15 /PRNewswire/ -- OrbusNeich today announced that multiple clinical data presentations in a symposium at EuroPCR 2008 support the use of the company's Genous Bio-engineered R stent, the world's first pro-healing stent, as a safe alternative to drug-eluting stents.
12-Month TRIAS HR Pilot Study Data
Presented by Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam, data from the TRIAS HR (high risk) Pilot study show similar target vessel failure (TVF) rates at 12-month follow-up for OrbusNeich's Genous Bio-engineered R stent and Boston Scientific's Taxus stent in high risk of restenosis patients.
In the patients treated with Taxus, there were four out-of-hospital thrombotic events, while there were no reported events in the Genous group. TRIAS HR Pilot is a randomized, 193-patient, single-center, prospective, single-blind study involving patients with a high risk of restenosis. 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 23 mm) and/or chronic total occlusions.
"Interventional cardiologists need better stent technologies," said de Winter, principal investigator of the TRIAS HR Pilot study. "A pro-healing approach with the Genous stent is a viable one. We look forward to obtaining further data on the stent's performance in our large, multi-center TRIAS trials that compare Genous to both drug-eluting and bare metal stents."
e-HEALING Interim Patient Subset Data
In addition, de Winter presented interim follow-up data from patient
subsets of e-HEALING, a monitored, multi-center, worldwide (outside the
United States) prospective registry with 5,000 enrolled patients. The data
based on the real-world use of the Genous Bio-engineered R stent show:
-- Good clinical outcomes at six and 12 months
-- A low target lesion revascularization (TLR) rate of 4.7% at 12 months
in patients with diabetes
-- A low incidence of stent thrombosis
The protocol for OrbusNeich's e-HEALING registry recommends that patients receive one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary outcome of the registry is TVF at 12 months.
"Genous appears to have the same efficacy as drug-eluting stents but a better safety profile with only minimal dual-antiplatelet therapy requirements," de Winter said.
Acute Myocardial Infarction (AMI) Patients
Huay-Cheem Tan, M.D., of National University Hospital in Singapore discussed published follow-up data on a study involving an initial 120 patients with AMI. The six-month data show a very low MACE rate of 5.8% with an early stent thrombosis rate of 1.7% and no reported thrombotic events from one to six months.
As part of an extended registry study, 321 patients with AMI were followed for one year. Even with the larger patient group, the MACE rate was 13.1% at one year with no mortality beyond the first month. The early stent thrombosis rate was 0.9% with no further thrombotic events beyond one month. The patients received dual-antiplatelet therapy for only 30 days.
In a comparison of a subset of diabetic patients with AMI, the Genous group had a six-month MACE rate of 8.9%, while a historical group of patients with bare metal stents (BMS) had a MACE rate of 15.4%. No thrombotic events were reported in the Genous group, and one event was reported in the BMS group.
"Based on a comparison of published data, our findings demonstrate that the Genous stent is feasible, effective and safe," said Tan. "This data might set the stage for a wider use of the pro-healing stent in patients with AMI."
Patients Who Could Not Tolerate Dual-Antiplatelet Therapy
Michael Kutryk, M.D., Ph.D., of St. Michael's Hospital in Toronto discussed the results of a compassionate-use study that enrolled 14 patients who could not tolerate dual-antiplatelet therapy or for whom the therapy was contraindicated. The study results show no thrombotic events at 17-month median follow-up.
"The implantation of a Genous stent should be considered first-line therapy in patients for whom dual-antiplatelet therapy is not an option," said Kutryk. "The Genous technology is critically important to this patient population for which there are limited treatments. In these cases, Genous might be the only lifesaving option."
Single-Center Registry of High-Risk Patients
Germano Di Sciascio, M.D., professor and chairman of cardiology at
Campus Biomedico, University of Rome, discussed the results of a study
involving 78 high-risk patients, 33% of whom were diabetic. In the study,
16% of the patients received multiple stents, and 56% of the lesions
treated were type B2/C. The majority of patients received clopidogrel for
two months. The results at 14-month follow-up show:
-- A TLR rate of only 4%
-- An event-free survival rate of 84%
-- No thrombotic events
-- A comparable MACE rate to the Taxus VI registry at nine months
"Given the current DES debate with the need for prolonged anti-aggregation, we believe this study demonstrated that Genous is a new armamentarium for PCI," said Di Sciascio.
Commenting on the functional importance of endothelial progenitor cells (EPCs) for accelerated natural healing, Jonathan Hill, M.D., of King's College, London, said, "Interventional cardiologists are taking notice of the critical role of EPCs in the vascular healing process. The Genous EPC capture technology is the first step in the development of biological stents, which moves the cardiologists into the realm of vascular biology."
Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient's EPCs to 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 Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.
OrbusNeich designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. The company's product portfolio includes the Genous Bio-engineered R stent, an antibody-coated device that is the first-ever stent to capture a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process following placement. Other products are stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent(TM), Sapphire(TM), Avita(TM), Avita HP(TM), SafeCut(TM), Lumina(TM) and Saffron.
A global company, OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo; and Shenzhen, China. OrbusNeich, which has provided cardiology devices to physicians through its predecessor companies since 1979, today supplies products to interventional cardiologists in more than 60 countries. For more information, visit http://www.OrbusNeich.com.
Editor's Note: OrbusNeich is displaying the Genous Bio-engineered R stent at Booth No. F06 at EuroPCR 2008.
Copyright©2008 PR Newswire.
All rights reserved