February 2, 2010 – Data published in EuroIntervention (EuroIntervention, 2010; 5:698-702) demonstrate good safety and efficacy, low target vessel revascularization (TVR) and no late stent thrombosis at one year in patients with ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI) and implantation of the Genous Bio-Engineered R Stent.
The prospective, observational study involved 321 patients with acute STEMI, without cardiogenic shock, who received 357 Genous stents. The rate of major adverse cardiac events (MACE) was 8.1 percent at 30 days, 10 percent at six months and 12.2 percent at one year. Only one patient developed acute stent thrombosis, and two others developed subacute stent thrombosis. There were no cases of late stent thrombosis. This was despite the fact that patients were treated with only one month of dual anti-platelet therapy. The data were published by Huay Cheem Tan, MBBS, of National University Hospital in Singapore.
“The healing process at the culprit sites in patients with STEMI differs between bare metal stents and drug-eluting stents. There is pathologic evidence to suggest that the usage of DES results in delayed stent endothelialization and increases the likelihood of stent thrombosis,” said Tan. “The positive results in this study, especially the low acute and subacute thrombosis rates, demonstrate that the prohealing approach of the Genous stent makes the device safe for use in most patients with STEMI.”
In the study, the TVR rate was 0.9 percent at 30 days, 2.8 percent at six months, and 4.4 percent at one year. Thirty percent of the patients in the study were diabetic, and 25 percent had bifurcation lesions.
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 anti-body 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 is commercially available in more than 60 countries. 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 nonresponsive to or cannot tolerate long-term dual anti-platelet therapy.
For more information: www.OrbusNeich.com