HONG KONG, July 18, 2011 /PRNewswire/ -- Data from high-risk patients requiring early discontinuation of dual antiplatelet therapy (DAPT) due to nondeferrable, non-cardiac surgery show good short- and long-term clinical and safety outcomes following treatment with OrbusNeich's Genous Stent, according to a study published online on the journal Minerva Cardioangiologica's website.
In the single-center study, patients treated with the Genous endothelial progenitor cell (EPC) capture stent discontinued DAPT between 21 and 30 days post-procedure and underwent non-cardiac surgical intervention within 60 days of percutaneous coronary intervention (PCI). Despite the shortened period of DAPT administration, there were no cases of stent thrombosis (ST) observed in patients treated with Genous. Additionally, no cases of perioperative major adverse cardiac events (MACE) were detected. After a mean follow-up of 15.4+/-10.3 months, two cases of cardiac death were reported, with no ischemia-driven target lesion revascularization (TLR) observed.
"Patients in need of revascularization and subsequent non-cardiac surgery are a significant management challenge due to their increased risk for major adverse cardiovascular events related to stent thrombosis and intra-operative bleeding," said Paolo Scacciatella, M.D., of the Department of Cardiovascular and Thoracic Diseases, S. Giovanni Battista University Hospital, Turin, Italy, and lead author of the publication. "The results from this study confirm the feasibility and safety of the Genous Stent in patients requiring early discontinuation of DAPT as a result of nondeferrable surgical intervention. Given the lack of stent thrombosis over the long term in patients with high clinical and angiographic risk, the Genous Stent represents an attractive alternative to bare metal and drug eluting stents for these complex cases."
The study included 26 patients who underwent PCI and 20 patients then received non-cardiac surgical intervention within 60 days of the PCI. The primary outcome of the study was the occurrence of cardiac death, myocardial infarction (MI), ST and MACE. According to the American Heart Association /American College of Cardiology (AHA/ACC) guidelines, non-cardiac surgery should be delayed by four to six weeks following PCI with a bare metal stent (BMS) and one year following PCI with a drug eluting stent (DES).
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 6,000 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 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™ 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.