OrbusNeich's Genousâ„¢ Stent is Safe and Effective in Cases Where Prolonged Dual Antiplatelet Therapy is Not Advisable as Presented at EuroPCR 2011
PARIS, May 19, 2011 /PRNewswire/ -- OrbusNeich announced that data from multiple clinical trials supporting the safety and efficacy of the Genous Stent in cases where prolonged dual antiplatelet therapy (DAPT) is not advisable were featured today during the HEALING Symposium titled "How to assess and treat patients who are not suitable candidates for prolonged dual antiplatelet therapy" at EuroPCR 2011 in Paris.
Presenters discussed current treatment alternatives to drug eluting stents (DES) for patients who are contraindicated for prolonged DAPT and the benefits of the Genous endothelial progenitor cell (EPC) capture technology for addressing these challenging cases. The symposium also explored the potential for new imaging tools to assess stent apposition and arterial healing in a clinical setting.
Robbert de Winter, M.D., Ph.D., of the Academic Medical Center, Amsterdam, presented three-year follow-up data that demonstrated the safety and efficacy of the Genous Stent in a large real-world patient population with mostly complex lesions and estimated high risk for restenosis. At three years, the definite stent thrombosis (ST) in 405 unselected patients treated with the Genous Stent was 0.5%, which was unchanged from one year, and there was a probable ST in one patient, which increased the rate of probable ST to 1.0% at three years compared to 0.8% at one year. In addition, the target lesion revascularization (TLR) rate at three years was 14.2% versus 10.6% at one year.
"These long-term data show no additional cases of definite stent thrombosis between one and three years attests to the durability and excellent safety profile of the Genous Stent," said Prof. de Winter.
Jonathan Hill, M.D., of King's College Hospital in London discussed the need to modify practices with an awareness of bleeding risk. He defined the predictors of high risk for bleeding to be age (>80), a previous bleeding episode, gender (female), renal in