Results from the Multicenter GENOUS Trial Show Safety of the Genous Stent Combined with a 10-Day Dual Antiplatelet Regimen
HONG KONG, Dec. 12, 2011 /PRNewswire-Asia/ -- OrbusNeich today announced that data published in the November issue of EuroIntervention indicate that the Genous Stent is safe when accompanied by only 10 days of dual antiplatelet therapy (DAPT).
In a multicenter trial involving 49 patients treated with Genous, no patient had died or had reached the study's primary endpoint of sudden cardiac death, myocardial infarction or angiographic evidence of stent thrombosis (ST) ascribable to the study stent at three-month follow-up. At this time, three patients had undergone repeat revascularization, with target lesion revascularization (TLR) in two patients.
"Despite this very short-term DAPT regimen, we observed only one case of ST at 26 days in a patient who had previously undergone percutaneous coronary intervention and stenting in the mid-left anterior descending artery with a bare metal stent," said Prof. Giuseppe M. Sangiorgi, corresponding author of the study, University of Rome Tor Vergata, Rome, Italy. "Coronary angiography disclosed thrombotic occlusion in this stent, while the nearby Genous Stent appeared patent and devoid of thrombus. This supports the case for Genous as a safe and effective treatment alternative for patients who cannot comply with a four-week-or-longer course of DAPT due to either bleeding risk or the need for a near-term invasive non-cardiac procedure."
Prof. Antonio Colombo, EMO GVM Centro Cuore Columbus and the Interventional Cardiology Unit, S. Raffaele Hospital, Milan, Italy, and principal investigator of the study, added, "The data obtained are encouraging and may justify the launch of a larger study powered to test the possibility to utilize the Genous stent with reduced duration of dual antiplatelet therapy."
The study included patients with de novo lesions in vessels able to receive a 2.5 mm Genous Stent. Patients received clopidogrel for 10 days, accompanied by lifelong aspirin administration. Seventy percent of the patients discontinued clopidogrel nine to 11 days after stenting. For the patients treated, the average age was 64.2 years, with 83.4 percent male patients and 18.7 percent of patients having been diagnosed with diabetes mellitus. Approximately half of the patients (55.1 percent) were diagnosed with multivessel disease, and the left anterior descending artery branches were the most commonly treated (61.2 percent of cases). A total of 55 Genous Stents were implanted.
About Genous Technology
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 7,000 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.
About OrbusNeich
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 neo-intimal proliferation through the combination of the Genous pro-healing technology with an abluminal sirolimus drug elution. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, mainland 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.
Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich, and learn more about the company and the Genous technology on OrbusNeich's YouTube Channel: http://www.youtube.com/user/OrbusNeichMedia.
