Genous demonstrates “impressive” results in high-risk patients


OrbusNeich’s pro-healing stent technology was featured at a symposium during Angioplasty Summit TCT Asia Pacific 2009, 22-24 April, at the Convention Center of Sheraton Grande Walkerhill Hotel in Seoul, South Korea.

Presented by Dr Margo Klomp, Academic Medical Center (AMC), Amsterdam, The Netherlands, final adjudicated 12 month follow-up results from the randomised single-centre TRIAS High Risk (HR) study showed a slightly higher target lesion revascularisation rate with the Genous-treated patient group compared with patients receiving the Taxus drug-eluting stent, but there were no stent thrombosis events at any time period in the 98 patient Genous group with only one month of dual antiplatelet therapy. In the 95-patient Taxus cohort, the stent thrombosis rate was 4.2%, including late stent thromboses at 155 and 200 days, even though all patients were on dual antiplatelet therapy at the time of stent thrombosis. The composite of death and myocardial infarction for Genous was 4.1% vs. 7.3% for Taxus. “Within a month we will complete two-year follow-up on these patients and we anticipate these results will hold up longer term,” said Klomp.

In a separate study involving 446 consecutive patients presented with an acute myocardial infarction treated with Genous, Dr Harry Suryapranata, Isala Klinieken in Zwolle, The Netherlands, presented 30-day follow-up with only one patient (.2%) having stent thrombosis. Suryapranata commented, “This rate is impressively low given the highly thrombotic environment associated with AMI patients.” Longer-term follow-up is ongoing.

Dr Juan F Granada, medical director of the Skirball Center for Cardiovascular Research at Columbia University Medical Center, USA, presented results from pre-clinical models demonstrating the effectiveness in combining OrbusNeich’s prohealing cell capture with their fully absorbable drug-elution technologies to address the shortcomings with current drug-eluting stents, namely the safety concerns associated with the delay and often lack of endothelialisation. “In multiple models we have results indicating that this new technology appears to effectively regulate neointimal growth, while at the same time promotes the restoration of the arterial wall,” explained Granada. These studies highlight the development progress with the next generation of prohealing drug-eluting stent featuring a combination of endothelial progenitor cell (EPC) capture technology and the abluminal deposition of a fully-absorbable sirolimus-eluting matrix.

“Each of these complex technologies on their own offer solutions to the interventionalist,” said Dr Seung-Jung Park, chairperson of the symposium. “By integrating these onto one innovative platform, OrbusNeich is making tremendous strides in being able to offer a single stent addressing multiple concerns.”

Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient’s EPC to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent, providing a safe and effective alternative to drug-eluting stents.