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% at 30 days, 10% at six months and 12.2% 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 antiplatelet therapy.
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.
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 very 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.”