Bioengineered stent safe and effective in cases where prolonged dual antiplatelet therapy is not advisable


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 during the HEALING Symposium, “How to assess and treat patients who are not suitable candidates for prolonged dual antiplatelet therapy” at EuroPCR 2011.

Presenters discussed current treatment alternatives to drug-eluting stents for patients who are contraindicated for prolonged DAPT and the benefits of the Genous endothelial progenitor cell (EPC) capture technology for addressing these 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, Academic Medical Center, Amsterdam, The Netherlands, 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 in 405 unselected patients treated with the Genous Stent was 0.5%, which was unchanged from one year, and there was a probable stent thrombosis in one patient, which increased the rate of probable stent thrombosis to 1% at three years compared with 0.8% at one year. In addition, the target lesion revascularisation rate at three years was 14.2% versus 10.6% at one year. “That 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 De Winter.

Jonathan Hill, King’s College Hospital, London, UK, 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 insufficiency and low and high body mass index. He added that Genous was an “ideal” treatment strategy for patients at increased risk of bleeding or requiring urgent surgery.


In a presentation entitled “Endothelial progenitor cell-capture technology: mechanism of action and potential benefits,” Eric Duckers, Erasmus University Medical Center, The Netherlands, presented clinical data from an ex vivo arteriovenous (AV) shunt model of human circulating blood, which demonstrated that the Genous Stent increased the rate of endothelialisation and reduced thrombogenicity compared with a bare metal stent. He said: “These data demonstrate the importance of CD34+ cells for endothelialisation and the prevention of thrombosis”


Stephen Wai-Luen Lee, Queen Mary Hospital,University of Hong Kong, presented a pilot study on very early healing of the Genous EPC capturing stent using frequency domain optical coherence tomography technology – the EGO Study in 50 patients (still enrolling). By 15 days, a very significant portion of the stent struts were covered by neointima and close to 100% strut coverage was seen with the stent at 28 days.