At 12 months the NEVO™ Sirolimus-eluting Coronary Stent has continued to demonstrate excellent safety and efficacy outcomes compared to Taxus® Liberte® according to new data presented today from the NEVO™ 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™ arm, whereas two such events have been reported through 12 months in patients treated with the Taxus® Liberté® 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™.
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™ over Taxus® Liberté® 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™ was reported to be superior to Taxus® Liberté® 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™ arm as compared to the Taxus® Liberté® arm (0.13 mm compared to 0.36 mm, p