Results from the e-HEALING Registry Show No Significant Difference in Stent Thrombosis for a Patient Population with Expected Poor Compliance with Dual Antiplatelet Therapy
HONG KONG, Nov. 7, 2011 /PRNewswire-Asia/ -- OrbusNeich today announced the publication of 12-month follow-up data from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry in Circulation Journal that show the Genous Stent is safe and effective in elderly patients.
In the study, no significant difference in stent thrombosis (ST) was observed at 12 months between elderly patients (aged 65 or older) and younger patients. The target lesion revascularization (TLR) rate was not significantly higher with increasing age. Target vessel failure (TVF), the main outcome of the study, was observed more often in elderly patients; TVF occurred in 11.7 percent of patients over the age of 75, in 8.8 percent of patients between the ages of 65 and 74, and in 7 percent of patients younger than 65. The increased rate of TVF in elderly patients was driven mainly by increased mortality.
"Early discontinuation of dual antiplatelet therapy (DAPT) has been identified as a major predictor for the occurrence of ST, and for this reason the elderly are at a particularly high-risk for ST due to their expected non-compliance with DAPT," said Dr. Andres Iniguez of the University of Vigo, Spain. "The elderly comprise an important subgroup of patients for whom long-term DAPT may not be advisable, and these data show that in patients over 65 the Genous Stent was safe and did not lead to an increased risk of ST despite their lower compliance."
The registry's main outcome was TVF at 12-month follow-up, defined as the composite of cardiac death or myocardial infarction (MI) unless unequivocally attributable to a non-target vessel and target vessel revascularization (TVR). Secondary outcomes were the composite of cardiac death, MI and clinically-indicated TLR, the individual outcomes all-cause death, cardiac death, MI (non-Q-wave or Q-wave), TLR, TVR, ST, major and minor bleeding and stroke.
e-HEALING, a multi-center, worldwide prospective clinical registry conducted at 144 centers in 31 countries outside of the United States, included 4,939 patients with at least one lesion suitable for non-urgent percutaneous coronary intervention (PCI) and Genous Stent implantation. In the patient population, 2,651 were under the age of 65, 1,403 were between the ages of 65 and 74, 794 were between the ages of 75 and 84, and 75 were over the age of 85. Elderly patients were defined as patients over the age of 65 and the very elderly as patients over the age of 75.
About Genous
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 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.
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, 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/OrbusNeichMedical.
