Data Published in the Journal of Interventional Cardiology Demonstrate Effectiveness and Safety of OrbusNeich's Genousâ„¢ Stent in Diabetic Patients
HONG KONG, March 23, 2011 /PRNewswire/ -- OrbusNeich today announced that 12-month outcomes data from a subset analysis of the global e-HEALING registry were published online ahead of print in the Journal of Interventional Cardiology and demonstrated the effectiveness and safety of the company's Genous Stent in diabetic patients, with low definite and probable stent thrombosis (ST) comparable to non-diabetics.
The study investigated the 1,236 diabetic patients from the e-HEALING registry, including 273 insulin requiring diabetics (IRD) and 963 non-insulin requiring diabetics (NIRD), and compared this cohort to the non-diabetic study participants.
The investigators found a target vessel failure (TVF) rate of 10 percent in diabetics, compared to 7.9 percent in non-diabetics. The TVF rates were 13.4 percent and 9 percent in IRD and NIRD, respectively. The higher TVF rates were driven mainly by a higher mortality hazard in both diabetic subgroups when compared to non-diabetics. The target lesion revascularization (TLR) rates were comparable in diabetics and non-diabetics, with 6.4 percent in diabetics versus 5.4 percent in non-diabetics. Definite or probable ST occurred in 1.1 percent of both diabetics and non-diabetics.
"Diabetics treated with percutaneous coronary intervention remain a high-risk subgroup," said Peter Damman, M.D., of the Academic Medical Center in Amsterdam and lead author of the paper. "These data show that Genous provides an effective alternative for managing thrombotic risk in this challenging group of patients."
The primary outcome for the e-HEALING registry was TVF at 12-month follow-up. TVF was defined as the composite of cardiac death or myocardial infarction (MI), unless unequivocally attributed to a non-target vessel, and target vessel revascularization (TVR).
The median age of the diabetic cohort was 64 years, 73 percent were male, and the mean body mass index (BMI) was 28.3. In diabetics