BARCELONA, Spain, May 15 OrbusNeich today announced thatmultiple clinical data presentations in a symposium at EuroPCR 2008 supportthe use of the company's Genous Bio-engineered R stent, the world's firstpro-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 MedicalCenter in Amsterdam, data from the TRIAS HR (high risk) Pilot study showsimilar target vessel failure (TVF) rates at 12-month follow-up forOrbusNeich's Genous Bio-engineered R stent and Boston Scientific's Taxus stentin high risk of restenosis patients.
In the patients treated with Taxus, there were four out-of-hospitalthrombotic 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. Highrisk of restenosis is defined as patients who have diabetes mellitus and/orsmall 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 deWinter, principal investigator of the TRIAS HR Pilot study. "A pro-healingapproach with the Genous stent is a viable one. We look forward to obtainingfurther data on the stent's performance in our large, multi-center TRIAStrials 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 patientsubsets of e-HEALING, a monitored, multi-center, worldwide (outside the UnitedStates) prospective registry with 5,000 enrolled patients. The data based onthe real-world use of the Genous Bio-engineered R stent show:
The protocol for OrbusNeich's e-HEALING registry recommends that patientsreceive one month of clopidogrel treatment after the procedure. Clinicalfollow-up takes place at 30 days, six months and 12 months. The primaryoutcome of the registry is TVF at 12 months.
"Genous appears to have the same efficacy as drug-eluting stents but abetter safety profile with only minimal dual-antiplatelet therapyrequirements," de Winter said.
Acute Myocardial Infarction (AMI) Patients
Huay-Cheem Tan, M.D., of National University Hospital in Singaporediscussed published follow-up data on a study involving an initial 120patients with AMI. The six-month data show a very low MACE rate of 5.8% withan early stent thrombosis rate of 1.7% and no reported thrombotic events fromone to six months.
As part of an extended registry study, 321 patients with AMI were followedfor one year. Even with the larger patient group, the MACE rate was 13.1% atone year with no mortality beyond the first month. The early stent thrombosisrate was 0.9% with no further thrombotic events beyond one month. The patientsreceived dual-antiplatelet therapy for only 30 days.
In a comparison of a subset of diabetic patients with AMI, the Genousgroup had a six-month MACE rate of 8.9%, while a historical group of patientswith bare metal stents (BMS) had a MACE rate of 15.4%. No thrombotic eventswere reported in the Genous group, and one event was reported in the BMS group.
"Based on a comparison of published data, our findings demonstrate thatthe Genous stent is feasible, effective and safe," said Tan. "This data mightset 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 Torontodiscussed the results of a compassionate-use study that enrolled 14 patientswho could not tolerate dual-antiplatelet therapy or for whom the therapy wascontraindicated. The study results show no thrombotic events at 17-monthmedian follo