OrbusNeich has announced the presentation of clinical data at Asia PCR/Singapore LIVE 2010, which demonstrated the benefits of its Genous Bio-engineered R stent in the treatment of two challenging patient subsets.
The presentations delivered by Robbert de Winter of the Academic Medical Center (AMC) in Amsterdam, and Wojciech Wojakowski from Medical University of Silesia in Poland, focused on the use of Genous Bio-engineered R stent in patients with bifurcation lesions and patients with non ST-segment elevation acute coronary syndrome.
Prof. de Winter’s presentation was titled ‘One Year Clinical Outcome after Provisional T Stenting with the Endothelial Progenitor Cell Capturing Stent for Bifurcation Lesions.’ It featured a single-center study with 178 patients that compared the Genous Bio-engineered R stent to a previous bare metal stent control group of 465 patients at the AMC.
A 32% reduction of the composite of cardiac death, myocardial infarction or target lesion revascularization was reported between these two groups. The cumulative rate of definite or probable stent thrombosis was reduced by 57% in the Genous Bio-engineered R stent-treated group, as compared to the control group.
Dr. Wojakowski presented data on the JACK-EPC trial, a comparison of the efficiency of high dose atorvastatin and endothelial progenitor-capture stents versus bare metal stents, in the reduction of neointimal formation in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
The randomized study with 60 patients compared the Genous Bio-engineered R stent with bare metal stents with concomitant high dose atorvastatin in the reduction of neointimal hyperplasia, assessed by coronary angiography and IVUS after six months.
In the JACK-EPC trial, the Genous Bio-engineered R stent induced less neointimal hyperplasia and a lower binary restenosis rate of 13% in the Genous Bio-engineered R stent, compared to 26.6% in the control group. The major adverse cardiac events (MACE) rate was reported at only 10% in the Genous Bio-engineered R stent treated patient group, versus 16% in the bare metal stent treated group, said the company.