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 the company's Genous Bio-engineered R stent is safe and demonstrated positive clinical outcomes in the high-risk patient group.
OrbusNeich said that 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.
According to 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%.
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, said the company.
Dr 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.”
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.”