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.
“NEVO™ is a critical component of our commitment to providing innovative new products, which are transforming expectations for patients and practitioners in the field of interventional cardiology.”
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<0.001).In-stent late lumen loss reduces the diameter of the lumen thus restricting blood flow through the stent and can potentially lead to major adverse coronary events, also known as MACE. NEVO™ was also superior in reducing restenosis, a reblockage in a stent. Angiographic restenosis was reduced 86 percent (1.1 percent in the NEVO arm compared to 7.8 percent in the Taxus Liberte arm,>
"These data suggest we may be looking at a significant advance in treatment options for coronary disease that allows precise stent-based delivery of drug and is capable of reducing long-term safety complications," said Alexandre Abizaid, MD, the chief of coronary interventions at the Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil and visiting professor of medicine at Columbia University, New York, USA. "Since stent thrombosis and the drugs required to protect against it are such significant clinical issues, it is particularly pleasing to see the excellent safety outcomes associated with NEVO™ maintained over 12 months. These results also suggest the need for further study of whether abbreviating or interrupting antiplatelet therapy with this treatment would result in fewer adverse events than would currently be expected in drug-eluting stent patients."
"The additional positive 12-month results from the NEVO™ RES-I trial are extremely encouraging as they suggest that NEVO™ could offer improved patient outcomes in the treatment of coronary artery disease," said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. "NEVO™ is a critical component of our commitment to providing innovative new products, which are transforming expectations for patients and practitioners in the field of interventional cardiology."
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