NEVO trade; Sirolimus-Eluting Coronary Stent Yields Superior Results To Taxus R Liberte R Stent In Pivotal Clinical Analysis
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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 read comparing these two drug-eluting stents were presented during Dilatory Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
"We are as well satisfied with the results from this trial and accept NEVO™ has the imaginable to return Cordis to global headship in the drug-eluting stent market," said Seth Fischer, Convention 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 only master allows narcotic 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 encircling three months based on in vivo data. By contrast, currently marketed drug-eluting stents keep 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 overdue lumen loss, which is tissue duration within a stent, reduces the diameter of the lumen thus restricting blood flow through the stent and can potentially lead to dominant adverse coronary events, extremely celebrated as MACE.
In addition, NEVO™ again 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™ as well 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). Bastinado events occurring between infirmary 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 appearance differences in clinical outcomes, however, patients treated with NEVO™ had numerically lower rates of events with dignity to goal lesion revascularization (1.6 percent for NEVO™ vs. 3.2 percent for the Taxus® Liberte® Stent; p=0.33) and the composite of casualty or love advance (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 concern with coronary stents and frequently results in feelings attacks or death. Based on the ARC (Academic Probation Consortium) definitions of stent thrombosis, which chalk up 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 leading 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 essential investigators of the NEVO RES I trial. "We further saw an emerging safety profile with NEVO™ that adds to our enthusiasm approximately the potential of this drug-eluting stent for patients with coronary artery disease."
Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Trial and Development, Cordis Corporation noted, "Not only did NEVO™ significantly outperform Taxus® Liberte® in far-reaching measures on the other hand these results besides indicate that the practicable for a strong safety profile supporting the opportunity for patient-specific tailoring of the drugs traditionally needed to prevent thrombosis is totally promising."
Dr. Rogers continued, "Based on these results, the potential for a strong safety profile with NEVO™ is altogether promising. NEVO™ is designed to doctor up patient outcomes by providing a sui generis vascular safety profile, the proven efficacy of Sirolimus and fine deliverability."
Results in Diabetic Patients in NEVO RES I
It is widely confessed that patients with diabetes tend to extant with enhanced compounded coronary lesions and are more challenging to treat. In the NEVO RES 1 study, a corresponding 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 debate of the 65 patients with diabetes completing six-month supervene up to date, there was a 60 percent reduction in in-stent unpunctual 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 favour of NEVO™ was similar to the 65 percent contraction 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 Recite 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. Pivotal secondary endpoints involve target lesion failure, cause vessel failure, major adverse cardiac events (MACE), stent thrombosis, target lesion revascularization, intention 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 peruse involved 394 patients at 40 sites throughout Europe, South America, Australia and Au courant Zealand. Patients received clinical follow-up at 30 days and six months and will be followed annually nailed down five years.
News from this check testament 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 all the more 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 supple and conformable with thin struts to maximize vessel coverage. The biodegradable polymer used to contain and proceeds Sirolimus facilitates rapid endothelialization and results of pre-clinical studies indicated no greater inflammation than seen with bare metal stents.
NEVO™ very contains the duplicate drug, Sirolimus, as the CYPHER® Sirolimus-eluting Coronary Stent, which has immediately been used in more than three million people worldwide. Counsel 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 Company besides announced today further information of the study designs for upcoming clinical trials for NEVO™.
NEVO II will be a global, randomized, non-inferiority probation comparing NEVO™ to the Xience V™ Everolimus-eluting Coronary Stent. The announce plans to enrol indefinite thousand patients with coronary artery disease and will include expanded enrollment in multiple patient subgroup. The primary endpoint of the interpret is reason 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 Publication Sabate, M.D., Infirmary de Sant Pau, Barcelona, Spain. Results from this test will provide long-term data in flotation of a Pre-market approval (PMA) operate with the U.S. Cuisine and Drug Administration (FDA).
NEVO III will be a non-randomized, single-arm evaluation evaluating clinical outcomes in enclosing 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., Plight Western Reserve University Institution of Medicine, Cleveland, OH; and David Kandzari, M.D., Scripps Clinic, San Diego, CA. NEVO™ will be compared to the CYPHER® Stent clout arm of the CYPHER Stent/DAPT (dual anti-platelet therapy) trial (described below).
The CYPHER® Stent/DAPT trial will enroll sorrounding 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 proof 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 bestow us with comparative data for NEVO™ against Taxus® Liberte®, Xience® and even our own CYPHER Stent," said Dr. Rogers. "These data will favor physicians and their patients with critical information to assess optimal treatments for coronary artery disease."
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