September 22, 2009—OrbusNeich (Fort Lauderdale, FL) 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. Robbert de Winter, MD, presented the data at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco.
According to the company, the study evaluated 4,987 of the 4,996 enrolled patients and found a target vessel failure rate of 8.1% at 12 months with a follow-up rate of 92%, a target lesion revascularization rate of 4.4%, a major adverse cardiac events (MACE) rate of 7.7%, a subacute thrombosis (SAT) rate of 0.5%, and a late stent thrombosis of 0.3%. The combined SAT and late thrombosis rate of 0.8% was per protocol. Per Academic Research Consortium definition, the definite and probable SAT and late thrombosis rate is 1%. Dr. de Winter reported that 25% of patients in the study had diabetes mellitus.
Also, in a poster presentation at TCT 2009, Dr. de Winter et al 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 target lesion revascularization rate of 4.6%, a per protocol SAT and late thrombosis rate of 0.9%, and a MACE rate of 8.9%.
According to the company, e-HEALING is a multicenter, worldwide (outside the United States), prospective clinical study conducted in 31 countries at 144 clinical centers. In addition to 25% of patients having diabetes mellitus, 42.4% of the patients had unstable angina, and 11% had preprocedure thrombus. For the lesions treated, 49.3% were type B2 or C. The study protocol recommends that patients receive 1 month of clopidogrel treatment after the index procedure. The primary endpoint of the study is target vessel failure at 12 months.
"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," commented Dr. de Winter. "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. The MACE rate is only 1.2% higher than the full cohort of the study and was mainly driven by mortality. We expect a higher mortality rate in diabetic patients due to other comorbidities."
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