Mar 18 2010
OrbusNeich today announced that 12 month follow up data from real world patients demonstrated long term clinical efficacy of the company's Genous Bio-engineered R stent.
Margo Klomp, M.D., of the Academic Medical Center (AMC) in Amsterdam, presented the data from 405 unselected patients treated at the AMC. The definite and probable stent thrombosis (ST) rate was 1.2 percent and no ST was reported between three months and one year. Dual anti-platelet therapy (DAPT) was recommended for one month and 16 of the patients were contra-indicated for DAPT, receiving only two weeks of clopidogrel post angioplasty. The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) was 13.3 percent. The clinically driven TLR rate by means of PCI was 9.1 percent and by means of coronary artery bypass graft surgery (CABG) was 1.7 percent. Ten patients died of cardiac causes and 11 patients suffered MI, of which six were peri-procedural and five spontaneous.
"The Genous Bio-engineered R stent shows good clinical outcomes in this unselected patient population with predominantly complex lesions," said Margo Klomp, M.D., presenter and co-investigator of the study. "Furthermore, using this stent avoids the need for long term DAPT."
The mean age of the study population was 63 +/- 11 years and 72 percent of patients were male. In addition, 18 percent of patients in the study cohort had diabetes mellitus. For the lesions treated, 75 percent were type B2/C lesions, 20 percent chronic total occlusion (CTO) lesions and 24 percent bifurcated lesions. The average stent length was 24.6 +/- 11.7 mm.
During a separate session, Dr Klomp presented the data of a patient treated with the Genous Bio-engineered R stent that underwent 6 and 18 months angiographic follow up.
"In our real world experience with the Genous Bio-engineered R stent, we have seen a significant regression of neointimal hyperplasia when we do longer term angiographic follow up," said Prof. Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam and a co-investigator of the study. "In several patients from this cohort, we saw a remarkable regression in intimal hyperplasia tissue between 6 and 18 month follow up."