Twelve-month follow-up data from the e-HEALING (Healthy endothelial accelerated lining inhibits neointimal growth) registry shows that the Genous stent (OrbusNeich) is safe and effective in elderly patients. The study was published in Circulation.
The registry show no significant difference in stent thrombosis at 12 months between elderly patients (aged 65 or older) and younger patients. The target lesion revascularisation rate was not significantly higher with increasing age. Target vessel failure, the main outcome of the study, was observed more often in elderly patients; it occurred in 11.7% of patients over the age of 75, in 8.8% of patients between the ages of 65 and 74, and in 7% of patients younger than 65. The increased rate of target vessel failure in elderly patients was driven mainly by increased mortality.
“Early discontinuation of dual antiplatelet therapy has been identified as a major predictor for the occurrence of stent thrombosis, and for this reason the elderly are at a particularly high-risk for stent thrombosis due to their expected non-compliance with dual antiplatelet therapy,” said Andres Iñiguez, University of Vigo, Spain. “The elderly comprise an important subgroup of patients for whom long-term dual antiplatelet therapy 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 stent thrombosis despite their lower compliance.”
e-HEALING, a multicentre, worldwide prospective clinical registry conducted at 144 centres in 31 countries outside of the United States, included 4,939 patients with at least one lesion suitable for non-urgent percutaneous coronary intervention 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.
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.