Primary PCI Outcomes Published for OrbusNeich’s Genous R Stent

February 1, 2010—OrbusNeich (Fort Lauderdale, FL) announced the publication of data demonstrating good safety and efficacy outcomes, low target vessel revascularization (TVR) rates, and no late stent thrombosis at 1 year in patients with ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI) and implantation of the company's Genous bioengineered R stent. The data were published by Huay Cheem Tan, MBBS, et al in EuroIntervention (2010;5:698–702). Investigators at Singapore's National University Hospital and Tan Tock Seng Hospital conducted the study.

According to the company, the prospective, observational study involved 321 patients with acute STEMI without cardiogenic shock, who received 357 Genous stents. Thirty percent of patients in the study were diabetic, and 25% had bifurcation lesions.

The rate of major adverse cardiac events was 8.1% at 30 days, 10% at 6 months, and 12.2% at 1 year. One patient developed acute stent thrombosis, and two others developed subacute stent thrombosis. There were no cases of late stent thrombosis, even though patients were treated with only 1 month of dual-antiplatelet therapy. The TVR rate was 0.9% at 30 days, 2.8% at 6 months, and 4.4% at 1 year.

"The healing process at the culprit sites in patients with STEMI differs between bare-metal stents and drug-eluting stents," commented Dr. Tan. "There is pathologic evidence to suggest that the usage of drug-eluting stents results in delayed stent endothelialization and increases the likelihood of stent thrombosis. 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."