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Three-Year Clinical Outcomes from Use of Genous™ Stent in Large, Real-World Patient Population Demonstrate Long-Term Safety and Efficacy
Date:11/8/2011

SAN FRANCISCO, Nov. 8, 2011 /PRNewswire/ -- OrbusNeich today announced that three-year clinical outcomes data from the use of the Genous Stent in a large, real-world patient population demonstrate the device's long-term safety and efficacy. These results were published in the October issue of the Journal of Interventional Cardiology.

At three-year clinical follow-up, the study's primary endpoint, a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), in an unselected patient population was 18.3%. Between one and three years, TLR had increased by only 3.6%, and no cases of late and very late definite stent thrombosis (ST) were observed.

"This is the first report of three-year clinical outcomes for the Genous Stent, and it is important to recognize that only a small number of studies have ever reported on three-year outcomes following percutaneous coronary intervention with stent placement in an all-comer population," said Margo Klomp, M.D., of the Academic Medical Center, Amsterdam, and lead author of the publication. "The target lesion failure rate of 18.3% in this case is on the lower end of the spectrum versus reported DES outcomes. In addition, late and very late ST was absent in our Genous Stent treated cohort, whereas other registries have reported occurrence of late and very late ST in DES treated patients."

The single-center study included 405 unselected patients with mostly complex lesions with an estimated high risk of restenosis. Specifically, 47% of the patients had multivessel disease, and, 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
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