OrbusNeich has reported that data published in EuroIntervention demonstrated 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 data were published by Huay Cheem Tan of National University Hospital in Singapore. The prospective, observational study involved 321 patients with acute STEMI, without cardiogenic shock, who received 357 Genous stents.
In the study, the TVR rate was 0.9% at 30 days, 2.8% at six months, and 4.4% at one year. 30% of the patients in the study were diabetic, and 25% had bifurcation lesions.
Huay Cheem Tan, said: “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.
“The positive results in this study, the low acute and subacute thrombosis rates, demonstrate that the pro-healing approach of the Genous stent makes the device safe for use in most patients with STEMI.”
Al Novak, chairman and chief executive officer of OrbusNeich, said: “These results support our previous observations that the safety profile of the Genous Bio-engineered R stent is strong. Interventional cardiologists face several challenges when treating patients with acute coronary syndromes, including patients needing primary PCI for STEMI.
“We expect that further studies will continue to demonstrate the potential for Genous in treating these patients, as well as diabetic patients and those who cannot tolerate dual antiplatelet therapy.”