OrbusNeich announced that 12-month follow-up data from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry demonstrated good clinical outcomes with low incidence of repeat revascularisation and stent thrombosis for the company’s Genous Stent. The results were published in the February issue of EuroIntervention.
Target vessel failure and target vessel revascularization were 8.4% at 12 months. The composite of death, myocardial infarction occurred in 7.9% of the patients. Target lesion revascularisation and stent thrombosis were 5.7% and 1.1%, respectively.
“The good clinical outcomes for the Genous Stent in real-world use, especially the low incidence of stent thrombosis, demonstrate that the pro-healing approach of the Genous Stent is effective for a range of challenging patient groups,” said Sigmund Silber from Kardiologische Klinik Dr Muller, Munich, Germany, co-principal investigator and one of the lead authors of the publication. “As shown previously in several subset analyses of the e-HEALING registry, the Genous Stent produces exceptional outcomes in diabetic and elderly patients.”
e-HEALING is a multicentre, worldwide prospective clinical registry conducted at 144 centres in 31 countries outside of the United States. It included 4,939 patients with at least one lesion suitable for non-urgent percutaneous coronary intervention and Genous Stent implantation. The mean age of the study population was 63 years, and 79% of patients were male. In addition, 25% of patients in the study cohort had diabetes mellitus, and 37% had a prior myocardial infarction.
On average, 1.3 lesions per patient were treated, 97.7% were de novo lesions, and 10% were bifurcation lesions. For the lesions treated, 49% were type B2/C lesions. At the 30-day visit, 83% of the patients were on dual anti-platelet therapy, 59% at six months and 34% at 12 months, respectively. The 12-month primary outcome was target vessel failure, and secondary outcomes included composite of cardiac death, myocardial infarction or target lesion revascularisation, and individual outcomes, including stent thrombosis.
About Genous Stent
Genous is OrbusNeich’s patented endothelial progenitor cells (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 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.