HONG KONG, Jan. 10, 2011 /PRNewswire/ -- Data from patients who are considered high-risk due to underlying clinical conditions and who cannot be treated with drug eluting stents (DES) and the accompanying requirement of long-term dual antiplatelet therapy (DAPT) showed positive safety and short- and long-term clinical outcomes following treatment with OrbusNeich's Genous Stent, according to a study published online in EuroIntervention (published-ahead-of-print, August 2010).
Known contraindications for DAPT include hypersensitivity or allergy to aspirin, a hemorrhagic risk, or a planned surgery shortly after percutaneous coronary intervention (PCI) that would require cessation of DAPT.
In the study, the major adverse cardiac events (MACE) free survival rate in patients treated with the Genous Stent was 80.6% after one year. Between year one and year two, no additional MACE were observed. In patients who underwent surgical treatment shortly after PCI, no perioperative MACE or thrombotic events occurred. Despite a very short period of DAPT use of 15 to 30 days, there were no cases of sub-acute, late or very late stent thrombosis in treated patients. The cumulative incidence of cardiac death was 1.6%, which is low considering the high risk patient population.
"The Genous Stent is an important and extremely attractive option for interventional cardiologists to safely manage high-risk patients who are contraindicated for prolonged DAPT and, therefore, should not receive a DES," said Paolo Scacciatella, M.D., Ph.D., of the Molinette Hospital Turin, Italy, and principal investigator of the study. "This is the first study that demonstrates the feasibility and efficacy of the Genous Stent in this particular segment of patients who are challenging to treat."
Emanuele Meliga, M.D., Ph.D., FESC, of Ordine Mauriziano Hospital in Turin, Italy, and corresponding author of the publication added, "We have observed that the Genous Stent, which accelerates the natural healing process, enables a shorter post-procedural period of DAPT without increasing the risk of late or very late stent thrombosis and without causing dangerous delays for patients who require non-cardiac surgery shortly after PCI."
The single-center study investigated 61 high-risk patients with a clear contraindication to prolonged DAPT. A high-risk condition was defined as meeting at least two of the following criteria: diabetes, acute coronary syndrome, heart failure, proximal vessel disease, multivessel disease, B2/C type lesions, bifurcating lesions and long lesions. The study's primary outcome measures were the occurrences of death, MI, target vessel revascularization (TVR), target lesion revascularization (TLR) and MACE, defined as a non-hierarchical composite of all cause death, nonfatal MI or repeat revascularization.
"This study adds to the growing body of knowledge published in peer-reviewed biomedical publications that supports the use of Genous for the treatment of challenging coronary indications," said Stephen M. Rowland, Ph.D., vice president of research and development at OrbusNeich. "We see in this case that high-risk patients with confounding co-morbidities precluding the use of DES still have an option that is safe and effective in the long-term."
Genous is OrbusNeich's patented endothelial progenitor cell (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 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients who 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 stents, balloons and guiding catheters marketed under the names of Blazer™, R stent, Scoreflex™, Sapphire™ and Sapphire NC. Development stage products include the Combo™ Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.
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