At six months, the NEVO™ Sirolimus-eluting Coronary Stent, incorporating RES Technology™, was superior to the Taxus® Liberte® Stent in reducing tissue growth within the stent that can potentially lead to repeat procedures, in new clinical study results released . In addition, no reports of stent thrombosis were reported in patients treated with NEVO™ through six months.
The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
"We are extremely pleased with the results from this trial and believe NEVO™ has the potential to return Cordis to global leadership in the drug-eluting stent market," said Seth Fischer, Company Group Chairman and Worldwide Franchise Chairman, Cordis Corporation.
NEVO™ is the first drug-eluting stent utilizing RES Technology™, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.
The NEVO™ Sirolimus-eluting Coronary Stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64 percent in the NEVO™ arm as compared to the Taxus® Liberte® arm (0.13 mm compared to 0.36 mm, p
Stent thrombosis can be a significant clinical issue with coronary stents and frequently results in heart attacks or death. Based on the ARC (Academic Research Consortium) definitions of stent thrombosis, which have been adopted by the interventional cardiology community, there were no reports of stent thrombosis in the 202 patients receiving NEVO™ while there were two reports of stent thrombosis in the 192 patients receiving the Taxus® Liberte® Stent, both of whom were on dual anti-platelet therapy at the time.
"In this trial, NEVO™ was superior to Taxus® Liberte® in a number of key safety and efficacy measures, including the primary end-point of late lumen loss," said Christian Spaulding, M.D., F.A.C.C., Professor of Cardiology, Assistance Publique-Paris Decartes University Hospitals, Paris, France and one of three primary investigators of the NEVO RES I trial. "We also saw an emerging safety profile with NEVO™ that adds to our enthusiasm about the potential of this drug-eluting stent for patients with coronary artery disease."
Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation noted, "Not only did NEVO™ significantly outperform Taxus® Liberte® in important measures but these results also indicate that the potential for a strong safety profile supporting the opportunity for patient-specific tailoring of the drugs traditionally needed to prevent thrombosis is quite promising."
Dr. Rogers continued, "Based on these results, the potential for a strong safety profile with NEVO™ is quite promising. NEVO™ is designed to improve patient outcomes by providing a unique vascular safety profile, the proven efficacy of Sirolimus and excellent deliverability."
Results in Diabetic Patients in NEVO RES I
It is widely known that patients with diabetes tend to present with more complex coronary lesions and are more challenging to treat. In the NEVO RES 1 study, a similar magnitude of benefit of the NEVO™ Sirolimus-eluting Coronary Stent over the Taxus® Liberte® Stent was seen in patients with diabetes as in patients without diabetes.
In a pre-specified subset analysis of the 65 patients with diabetes completing six-month follow up to date, there was a 60 percent reduction in in-stent late lumen loss with NEVO™ versus the Taxus® Liberte® Stent (0.17 mm compared to 0.42 mm, p