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
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