12-Month Clinical Outcome Data Published Online in Catheterization and Cardiovascular Interventions

HONG KONG - OrbusNeich today announced that 12-month follow-up data from a large cohort of unselected patients with mostly complex lesions and an estimated high risk for restenosis demonstrated the long-term safety and efficacy of the company's Genous Stent, with a low incidence stent thrombosis (ST).  The data was published online in the journal Catheterization and Cardiovascular Interventions.

The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) at one-year follow-up was 13.3%, mainly attributed to TLR, which was 10.9%. The occurrence of the definite and probable ST was low, 0.5% and 0.7% respectively, with two definite, subacute STs. No differences regarding cardiac death, TLR and ST were observed in a subset analysis of diabetics versus non-diabetics.

"Our results show that the Genous Stent not only performs well in patients with non-complex coronary lesions, but also in our unselected patient population with more-complex lesions," said Margo Klomp, M.D., of the Academic Medical Center (AMC) in Amsterdam and one of the lead authors of the publication.

The single center study included 405 unselected patients, and 18% of the patients in the study cohort had diabetes mellitus. Sixty percent of the patients met the National Institute for Clinical Excellence (NICE) guidelines for the use of drug eluting stents (DES), defined as a target artery with a reference diameter of <3.0 mm or a lesion length of >15 mm, and were considered to have a higher risk of restenosis.

Of the lesions treated, 75% were type B2/C lesions, 20% were chronic total occlusion (CTO) lesions, and 24% were bifurcated lesions. The average stent length was 24.6 +/- 11.7 mm. Patients were treated with clopidogrel for one month, and 16 patients received clopidogrel for less than one month. The duration of aspirin administration was indefinite.

Source: OrbusNeich