New Approach to Coronary Stenting Shows Superior Results in Key Six-Month Safety and Efficacy Endpoints.
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 today. 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<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.”
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<0.03). The magnitude of the differences seen in favor of NEVO™ was similar to the 65 percent reduction seen in 277 non-diabetic patients (0.12 mm, compared to 0.34 mm in the Taxus® Liberte® arm, p<0.001).
NEVO RES I Study Overview
The NEVO RES I study is a randomized, multi-center comparison of the NEVO™ Sirolimus-eluting Coronary Stent to the Taxus® Liberte® Stent in de novo native coronary artery lesions. Key secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events (MACE), stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. A subset of patients in each treatment arm was evaluated via intravascular ultrasound (IVUS) at six months.
The study involved 394 patients at 40 sites throughout Europe, South America, Australia and New Zealand. Patients received clinical follow-up at 30 days and six months and will be followed annually through five years.
Data from this trial will support a regulatory filing for a CE mark in countries outside the United States.
The NEVO™ Sirolimus-eluting Coronary Stent is an investigational device. It is not yet approved or available for sale in any market.
About the NEVO™ Sirolimus-eluting Coronary Stent
NEVO™ is made of cobalt chromium, which makes the stent flexible and conformable with thin struts to maximize vessel coverage. The biodegradable polymer used to contain and release Sirolimus facilitates rapid endothelialization and results of pre-clinical studies indicated no greater inflammation than seen with bare metal stents.
NEVO™ also contains the same drug, Sirolimus, as the CYPHER® Sirolimus-eluting Coronary Stent, which has now been used in more than three million people worldwide. Data supporting the safety and efficacy of Sirolimus in coronary applications is now available out to six years, and this body of clinical evidence is completely unmatched by any other anti-restenotic stent.