Early Coronary Artery Healing Advantage of OrbusNeich's Combo Dual Therapy Stent(TM) Compared to the TAXUS(R) Stent Shown in Two Clinical Trial Subgroup Analyses
Published: May 18, 2012
PARIS, May 17, 2012 /PRNewswire/ -- OrbusNeich today announced that two subgroup analyses from the REMEDEE trial assessing vascular healing of the company's Combo Dual Therapy Stent versus the TAXUS paclitaxel-eluting stent demonstrate an early advantage with the Combo Stent. Presented at EuroPCR 2012, the data were obtained with frequency-domain optical coherence tomography (FD-OCT) and virtual histology-intravascular ultrasound (VH-IVUS) at nine-month follow-up.
An independent OCT core laboratory performed a blinded quantitative analysis of the percent strut coverage and in stent neointimal characteristics along with a qualitative assessment of neointimal tissue appearance and make-up of 23 Combo Stents and 10 TAXUS stents at nine-month follow-up.
Specifically, the data show that neointimal volumes and thicknesses as measured with OCT were comparable at nine months post-implantation for both the Combo Stent and TAXUS stent as determined by a blinded OCT core lab analysis. However, the qualitative analysis inside the stent showed a more homogenous neointimal tissue appearance in the Combo Stent compared to the TAXUS stent. In detail, the Combo Stent placements had statistically significant more homogeneous tissue appearance compared to the TAXUS stent placements (79.2% versus 40%). Heterogeneous and layered tissue appearance was observed in 60% of the TAXUS stent placements and in 20.8% of the Combo Stent placements. Additionally, there were fewer microvessels and macrophage-like appearances inside the Combo Stent compared to the TAXUS stent: 8.3% versus 30% microvessels; 4.2% versus 10% macrophage-like appearances.
"These intriguing data possibly demonstrate a more homogenous tissue appearance with the Combo Stent versus a more heterogeneous appearance with the TAXUS stent in a blinded analysis," said Akiko Maehara, M.D.,director of Intravascular Imaging Core Laboratory at the Cardiovascular Research Foundation and assistant professor of medicine at Columbia University College of Physicians and Surgeons in New York. "There is a trend of differences in morphology that may support the Combo Stent's approach of improved vascular healing while maintaining effective control of neointimal proliferation."
A second study evaluated 23 baseline and 15 follow-up VH-IVUS assessments of a subset of patients from the REMEDEE trial to assess the vascular healing response of the Combo Stent compared to the TAXUS stent at nine months. The Combo Stent showed less neointimal proliferation and significantly less confluent necrotic core than the TAXUS stent. The necrotic core volume in the neointimal hyperplasia had an average of 2.8 mm3 in the Combo Stent compared to 4.2 mm3 in the TAXUS stent. Additionally, the Combo Stent had predominantly homogeneous fibrotic neointima.
"The Combo Stent is the only technology that combines the value of endothelial progenitor cell capture to promote vessel healing with an abluminal sirolimus drug elution to limit neointimal proliferation," said Stephen M. Rowland, Ph.D., vice president of research and development at OrbusNeich. "We are committed to bringing innovation to interventional cardiologists to help them address unmet needs with contemporary percutaneous coronary intervention."
The Combo Stent, the world's first dual therapy stent (DTS), combines an abluminal biodegradable sirolimus elution for the regulation of hyperplasia with Genous, OrbusNeich's proven endothelial progenitor cell (EPC) capture technology, to accelerate re-endothelialization.
About the Genous Technology
Genous is OrbusNeich's patented EPC capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
The Genous Stent, which has been commercially available in more than 60 countries since 2005, has been proven as a safe, effective alternative to drug eluting stents and is supported by data from more than 7,000 patients in clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients that are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Stent, as well as other stents and balloons marketed under the names of Azule, R stent, Scoreflex, Sapphire, Sapphire II and Sapphire NC. Development stage products include the Combo Dual Therapy Stent, the only dual therapy stent to both accelerate endothelial coverage and control neointimal proliferation through the combination of the Genous pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.
Note: OrbusNeich will display its stents at booth N6 at EuroPCR 2012.