HONG KONG, Jan. 5, 2012 /PRNewswire/ -- OrbusNeich today announced that 12-month follow-up data from a post-hoc analysis of the e-HEALING registry demonstrate that the company's Genous Stent achieves good, comparable clinical and safety outcomes in patients discontinuing dual antiplatelet therapy (DAPT) at 30 days and at six months. According to the study, clinical outcomes in patients treated with Genous were not associated with the duration of DAPT. The study has been published online in Catheterization and Cardiovascular Interventions.
For the analysis, patients were analyzed according to continuation or discontinuation of DAPT at 30-day and 6-month landmarks, with each landmark constituting a new baseline and the outcomes were assessed up to 12 months after stent placement. Target vessel failure (TVF), the study's main outcome, was 6.5 percent in patients continuing DAPT at 30 days versus 6.3 percent in patients who stopped at 30 days and 2.4 percent in patients continuing DAPT at 6 months versus 2.9 percent in patients who stopped at 6 months. Notably, no significant differences in stent thrombosis (ST) were observed in patients continuing DAPT compared to those who stopped at 30 days or at six months.
"Studies have shown that early discontinuation of DAPT after the placement of a drug eluting stent is associated with higher rates of stent thrombosis," said Peter Damman, M.D., of the Academic Medical Center in Amsterdam and first author of the publication. "Unfortunately, for patients who are expected to be non-compliant with their course of DAPT or for those who are at a high risk for bleeding, long-term DAPT is not desirable. These results reaffirm the safety and efficacy of the Genous Stent when accompanied by only one month of DAPT and support the use of Genous as an alternative to drug eluting stents in cases where DAPT may need to be stopped early after stenting."
The study evaluated patient outcomes from e-HEALING, a multi-center, worldwide prospective clinical registry conducted in 31 countries outside of the United States that included 4,939 patients with at least one lesion suitable for non-urgent percutaneous coronary intervention (PCI) and Genous Stent implantation. For the analysis, TVF was defined as target vessel-related cardiac death or myocardial infarction and target vessel revascularization.
About the 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.
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/OrbusNeichMedia.