News | May 03, 2010

Bioengineered Stent Shows Good Outcomes in High-Risk Elderly Patients

May 3, 2010 – Excellent safety and clinical outcomes were shown in patients ages 70 and older who received a stent using endothelial progenitor cell capture technology. The stent accelerates the natural healing process of the vessel wall after stent implantation.

The final 12-month clinical results of the global e-HEALING Registry for the Genous Bioengineered R stent were presented this week by Andres Iniguez, M.D., of the Hospital Universitario de Vigo in Vigo, Spain, at the Angioplasty Summit Transcatheter Cardiovascular Therapeutics Conference Asia Pacific 2010 in Seoul, South Korea.

The subset analysis evaluated 1,567 patients with a mean age of 75 from the e-HEALING clinical study and found a composite hierarchical major adverse cardiac event (MACE) rate of 9.9 percent with no Q-wave myocardial infarction (MI) at 12 months. The target lesion revascularization (TLR) rate was 6.7 percent, and the rate of target vessel failure (TVF) was 10.4 percent at 12 months. Per Academic Research Consortium (ARC) definition, the definite and probable subacute thrombosis (SAT) rate at 12 months was 0.9 percent, and the rate of late stent thrombosis (LST) was 0.3 percent.

Of the 1,063 male (67.8 percent) and 504 female (32.2 percent) patients, 39 percent had a prior acute myocardial infarction. Of the 2,169 lesions treated in the patient subset, 54.5 percent were type B2 or C. The study protocol recommends that patients receive one month of dual antiplatelet therapy post index procedure.

"Elderly patients represent an important segment of individuals undergoing PCI (percutaneous coronary intervention) procedures," said Iniguez, the presenter of the study. "We are especially pleased to see excellent clinical outcomes in this high-risk patient subset for whom long-term dual antiplatelet therapy is not ideal. Elderly patients often require medication and noncardiac surgery that can interfere with the post PCI standard of care. The Genous Bioengineered R stent compares favorably to most DES (drug-eluting stent) registries without necessitating long-term dual antiplatelet therapy."

e-HEALING is a multicenter, worldwide prospective clinical registry conducted in 31 countries at 144 clinical centers.

OrbusNeich's Genous Bioengineered R stent is commercially available in more than 60 countries and is offered as an alternative to drug-eluting stents.

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