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<0.001). In-stent late lumen loss, which is tissue growth within a stent, 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.
In addition, NEVO also showed superior angiographic results to the Taxus Liberte Stent in reducing restenosis, a reblockage in a stent, at six months. Angiographic restenosis was reduced 86 percent (1.1 percent in the NEVO arm compared to 8.0 percent in the Taxus Liberte arm, p<0.002).
NEVO also reduced the incidence of MACE (major adverse coronary events) by more than 40 percent compared to the Taxus Liberte Stent (4.1 percent vs. 7.0 percent respectively; p=0.226). MACE events occurring between hospital discharge and six months were reduced 67 percent from 4.8 percent with the Taxus Liberte Stent to 1.6 percent with NEVO (p=0.08).
NEVO RES I was not designed to show differences in clinical outcomes, however, patients treated with NEVO had numerically lower rates of events with respect to target lesion revascularization (1.6 percent for NEVO vs. 3.2 percent for the Taxus Liberte Stent; p=0.33) and the composite of death or heart attack (2.6 percent vs. 4. 3 percent respectively; p=0.26) compared to patients receiving the Taxus Liberte Stent.
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.”
It is widely known that patients with diabetes tend to present with more complex coronary lesions and are more challenging to treat.