SAN FRANCISCO, Sept. 22 /PRNewswire/ -- OrbusNeich today announced that the final 12-month clinical data from the global e-HEALING clinical study showed that the company's Genous Bio-engineered R stent is safe and effective in real world use, including in the treatment of patients with diabetes mellitus.
The study evaluated 4,987 of the 4,996 enrolled patients and found a target vessel failure (TVF) rate of 8.1 percent at 12 months with a follow-up rate of 92 percent, a target lesion revascularization (TLR) rate of 4.4 percent, a major adverse cardiac events (MACE) rate of 7.7 percent, a subacute thrombosis (SAT) rate of 0.5 percent and a late stent thrombosis (LST) of 0.3 percent. The combined SAT and late thrombosis rate of 0.8 percent was per protocol. Per Academic Research Consortium (ARC) definition, the definite and probable SAT and late thrombosis rate is 1.0 percent. The data were presented by Professor Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2009, in San Francisco.
"The excellent study design, electronic data capture and monitoring as well as comprehensive data management resulted in robust data for the e-HEALING clinical study, which further supports the efficacy and safety of the Genous Bio-engineered R stent," said de Winter, a co-principal investigator of the study. "We are especially pleased to see positive results in certain subsets of patients, such as diabetic patients, which often present as challenging cases with an expected higher incidence of in-stent-restenosis."
Twenty five percent of the patients in the study had diabetes mellitus. In a poster presentation, also at TCT 2009, de Winter and colleagues reported data from an analysis of this subset of the e-HEALING study. The 12-month follow-up from these 1,243 patients with diabetes mellitus showed a low TLR rate of 4.6 percent, a per protocol SAT and late thrombosis rate of 0.9 percent, and a MACE rate of 8.9 percent.
"The MACE rate is only 1.2 percent higher than the full cohort of the study and was mainly driven by mortality," said de Winter. "We expect a higher mortality rate in diabetic patients due to other comorbidities."
e-HEALING is a multi-center, worldwide (outside the United States) prospective clinical study conducted in 31 countries at 144 clinical centers. In addition to 25 percent of patients having diabetes mellitus, 42.4 percent of the patients had unstable angina and 11 percent had pre-procedure thrombus. For the lesions treated, 49.3 percent were type B2 or C. The study protocol recommends that patients receive one month of clopidogrel treatment after the index procedure. The primary endpoint of the study is target vessel failure at 12 months. The advanced electronic data capture via the internet with built in consistency checks for data monitoring was conducted by KIKA Clinical Solutions, a leading provider of advanced EDC solutions for clinical trials. Cardialysis, an independent Contract Research Organization (CRO), ensured quality, consistency and completeness of the data through comprehensive data management and monitoring.
Sigmund Silber, M.D., F.A.C.C., F.E.S.C., a professor of medicine with the Cardiology Practice and Hospital, Munich, and co-principle investigator, said, "Physicians rely on evidence-based recommendations for coronary interventions, and results from multicenter studies are more meaningful than those from a single center. The results from the large, multicenter e-HEALING study demonstrate the safety and efficacy of the Genous Bio-engineered R stent in a broad patient population - including remarkable outcomes for diabetic patients. This patient population shows a similar clinical outcome at 12-month follow-up compared to the total e-HEALING cohort, which demonstrates great potential for the stent in treating diabetic patients."
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.
OrbusNeich's Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent 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 Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP and Lumina(TM). OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. 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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