Paris, May 25, 2010 (ots/PRNewswire) – At 12 months the NEVO(TM) Sirolimus-eluting Coronary Stent has continued to demonstrate excellent safety and efficacy outcomes compared to Taxus(R) Liberte(R) according to new data presented today from the NEVO(TM) RES-I clinical trial. These results were presented as a late breaking trial at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
Through 12-month follow-up, there have been no episodes of stent thrombosis reported in the NEVO(TM) arm, whereas two such events have been reported through 12 months in patients treated with the Taxus(R) Liberte(R) stent, and a third event in this arm was reported after 13 months. Additionally there have been no cases of cardiac death or out-of-hospital myocardial infarction (MI) for patients receiving NEVO(TM).
While the trial was not powered for clinical endpoints and thus no statistically-significant differences were observed, the rates of death, MI, the need for repeat revascularization, and the occurrence of stent thrombosis numerically favored NEVO(TM) over Taxus(R) Liberte(R) to an even greater degree at 12 months than they had at six months. Similar trends were observed in the pre-defined subgroups of patients with diabetes and patients with lesion lengths less than or greater than 20 mm.
At the six-month primary endpoint of this prospective, randomized clinical trial, NEVO(TM) was reported to be superior to Taxus(R) Liberte(R) in in-stent late lumen loss, which is tissue growth within a stent. Specifically, in-stent late lumen loss was reduced by 64 percent in the NEVO(TM) arm as compared to the Taxus(R) Liberte(R) arm (0.13 mm compared to 0.36 mm, p
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