OrbusNeich has reported that a subset analysis of patients over 70 years of age in the final 12-month clinical results of the global e-Healing Registry confirmed that Genous Bio-engineered R stent is safe and demonstrated enhanced clinical outcomes in the high-risk patient group.
OrbusNeich said that e-Healing is a multi-center, worldwide prospective clinical registry conducted in 31 countries at 144 clinical centers. The subset analysis evaluated 1,567 patients with a mean age of 75 years old from the e-Healing clinical study and found a composite hierarchical major adverse cardiac event (MACE) rate of 9.9% with no Q-wave myocardial infarction (MI) at 12 months.
In the study, the target lesion revascularization (TLR) rate was 6.7%, and the rate of target vessel failure (TVF) was 10.4% at 12 months. Per Academic Research Consortium (ARC) definition, the definite and probable subacute thrombosis (SAT) rate at 12 months was 0.9%, and the rate of late stent thrombosis (LST) was 0.3%.
According to the study, of the 1,063 male (67.8%) and 504 female (32.2%) patients, 39% had a prior acute myocardial infarction. Of the 2,169 lesions treated in the patient subset, 54.5% were type B2 or C. The study protocol recommends that patients receive one month of dual antiplatelet therapy post index procedure.
Al Novak, chairman and CEO of OrbusNeich, said: “Elderly patients are a challenging subset that often displays several co-morbidities and frequently benefits from a shorter course of dual antiplatelet therapy. This study confirms that the Genous Bio-engineered R stent is both an effective and safe treatment alternative that can satisfy the special needs of these older patients.”
Andres Iniguez, the presenter of the study, said: “Elderly patients represent an important segment of individuals undergoing PCI procedures. 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 non-cardiac surgery that can interfere with the post PCI standard of care. The Genous Bio-engineered R stent compares favorably to most DES registries without necessitating long-term dual antiplatelet therapy.”