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 on 25 May 2010 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 specialising 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 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, myocardial infarction, the need for repeat revascularisation, 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 20mm.
At the six-month primary endpoint of this prospective, randomised 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% in the Nevo arm as compared to the Taxus Liberté arm (0.13mm compared to 0.36mm, 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% (1.1% in the Nevo arm compared to 7.8% in the Taxus Liberte arm, p=0.002).
“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, 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.”
NEVO RES-I Study Overview
The NEVO RES-I study was a randomised, multicentre comparison of Nevo to the Taxus Liberte Stent in de novo, native coronary artery lesions. The study involved 394 patients at 40 sites throughout Europe, South America, Australia and New Zealand. Patients underwent angiographic follow-up at six months, received clinical follow-up at 30 days and six and 12 months, and will be followed annually for the next five years. The primary endpoint was in-stent late loss at six months. Key secondary endpoints include target lesion failure, target vessel failure, MACE, stent thrombosis, target lesion revascularisation, target vessel revascularisation, and angiographic in-stent and in-segment binary restenosis at six months.
Cordis submitted Nevo for CE marking in March 2010. The device is not approved or available for sale in any market.