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Data Published in EuroIntervention Indicate that OrbusNeich's Genous™ Stent Is Safe with Very Short-Term Dual Antiplatelet Therapy
Date:12/5/2011

HONG KONG, Dec. 5, 2011 /PRNewswire/ -- OrbusNeich today announced that data published in the November issue of EuroIntervention indicate that the Genous Stent is safe when accompanied by only 10 days of dual antiplatelet therapy (DAPT).

In a multicenter trial involving 49 patients treated with Genous, no patient had died or had reached the study's primary endpoint of sudden cardiac death, myocardial infarction or angiographic evidence of stent thrombosis (ST) ascribable to the study stent at three-month follow-up. At this time, three patients had undergone repeat revascularization, with target lesion revascularization (TLR) in two patients.

"Despite this very short-term DAPT regimen, we observed only one case of ST at 26 days in a patient who had previously undergone percutaneous coronary intervention and stenting in the mid-left anterior descending artery with a bare metal stent," said Prof. Giuseppe M. Sangiorgi, corresponding author of the study, University of Rome Tor Vergata, Rome, Italy. "Coronary angiography disclosed thrombotic occlusion in this stent, while the nearby Genous Stent appeared patent and devoid of thrombus. This supports the case for Genous as a safe and effective treatment alternative for patients who cannot comply with a four-week-or-longer course of DAPT due to either bleeding risk or the need for a near-term invasive non-cardiac procedure."

Prof. Antonio Colombo, EMO GVM Centro Cuore Columbus and the Interventional Cardiology Unit, S. Raffaele Hospital, Milan, Italy, and principal investigator of the study, added, "The data obtained are encouraging and may justify the launch of a larger study powered to test the possibility to utilize the Genous stent with reduced duration of dual antiplatelet therapy."

The study included patients with de novo lesions in vessels able to receive a 2.5 mm Genous Stent. Patients received clopidogrel for 10 days, accompanied by lifelong aspirin administration.
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