Sexual HealthNEVO™ Sirolimus-Eluting Coronary Stent Yields Superior Results To Taxus(R) Liberte(R) Stent In Pivotal Clinical Trial
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, pResults 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, pNEVO 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.
Upcoming Clinical Trials for NEVO™Sirolimus-eluting Coronary Stent
Cordis Corporation also announced today additional information of the study designs for upcoming clinical trials for NEVO™.
NEVO II will be a global, randomized, non-inferiority trial comparing NEVO™ to the Xience V™ Everolimus-eluting Coronary Stent. The study plans to enroll several thousand patients with coronary artery disease and will include expanded enrollment in multiple patient subgroup. The primary endpoint of the study is target lesion failure at 12-months. The study will be led by Patrick Serruys, M.D., Erasmus University, Rotterdam, The Netherlands; Stephen Windecker, M.D., University of Bern, Switzerland; and Manual Sabate, M.D., Hospital de Sant Pau, Barcelona, Spain. Results from this trial will provide long-term data in support of a Pre-market approval (PMA) application with the U.S. Food and Drug Administration (FDA).
NEVO III will be a non-randomized, single-arm trial evaluating clinical outcomes in approximately 1,200 patients throughout the U.S. and Canada. The primary endpoint will be TLF at 12-months. The study will be led by Dan Simon, M.D., Case Western Reserve University School of Medicine, Cleveland, OH; and David Kandzari, M.D., Scripps Clinic, San Diego, CA. NEVO™ will be compared to the CYPHER® Stent control arm of the CYPHER Stent/DAPT (dual anti-platelet therapy) trial (described below).
The CYPHER® Stent/DAPT trial will enroll approximately 2,000 patients and will compare clinical outcomes in a broad range of patients receiving DAPT for 12 months versus 30 months after receiving a CYPHER® Stent. This trial will contribute to the company"s involvement in a broader DAPT clinical program, required by the FDA, which involves all FDA-approved drug eluting stents.
"The NEVO RES I, NEVO II and NEVO III trials will provide us with comparative data for NEVO™ against Taxus® Liberte®, Xience® and even our own CYPHER Stent," said Dr. Rogers. "These data will provide physicians and their patients with important information to assess optimal treatments for coronary artery disease."
Cordis Corporation