NEVO(TM) Sirolimus-Eluting Coronary Stent Continues to Demonstrate Excellent Safety and Efficacy Outcomes in New Twelve-Month Data
By Cordis Corporation, PRNEMonday, May 24, 2010
NEVO(TM), Incorporating RES TECHNOLOGY(TM), Continues to Support Excellent Safety and Efficacy Outcomes vs. the Taxus(R) Liberte(R) According to Data Presented at EuroPCR 2010
PARIS, May 25, 2010 - At 12 months the NEVO(TM) Sirolimus-eluting Coronary Stent has continued
to demonstrate excellent safety and efficacy outcomes compared to Taxus(R)
Liberte(R) according to new data presented today from the NEVO(TM) RES-I
clinical trial. These results were presented as a late breaking trial at
EuroPCR, the leading medical conference in Europe for physicians specializing
in interventional cardiovascular medicine.
Through 12-month follow-up, there have been no episodes of stent
thrombosis reported in the NEVO(TM) arm, whereas two such events have been
reported through 12 months in patients treated with the Taxus(R) Liberte(R)
stent, and a third event in this arm was reported after 13 months.
Additionally there have been no cases of cardiac death or out-of-hospital
myocardial infarction (MI) for patients receiving NEVO(TM).
While the trial was not powered for clinical endpoints and thus no
statistically-significant differences were observed, the rates of death, MI,
the need for repeat revascularization, and the occurrence of stent thrombosis
numerically favored NEVO(TM) over Taxus(R) Liberte(R) to an even greater
degree at 12 months than they had at six months. Similar trends were observed
in the pre-defined subgroups of patients with diabetes and patients with
lesion lengths less than or greater than 20 mm.
At the six-month primary endpoint of this prospective, randomized
clinical trial, NEVO(TM) was reported to be superior to Taxus(R) Liberte(R)
in in-stent late lumen loss, which is tissue growth within a stent.
Specifically, in-stent late lumen loss was reduced by 64 percent in the
NEVO(TM) arm as compared to the Taxus(R) Liberte(R) arm (0.13 mm compared to
0.36 mm, p<0.001).In-stent late lumen loss 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. NEVO(TM) was also superior
in reducing restenosis, a reblockage in a stent. Angiographic restenosis was
reduced 86 percent (1.1 percent in the NEVO arm compared to 7.8 percent in
the Taxus Liberte arm, p=0.002).
"These data suggest we may be looking at a significant advance in
treatment options for coronary disease that allows precise stent-based
delivery of drug and is capable of reducing long-term safety complications,"
said Alexandre Abizaid, MD, the chief of coronary interventions at the
Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil and visiting
professor of medicine at Columbia University, New York, USA. "Since stent
thrombosis and the drugs required to protect against it are such significant
clinical issues, it is particularly pleasing to see the excellent safety
outcomes associated with NEVO(TM) maintained over 12 months. These results
also suggest the need for further study of whether abbreviating or
interrupting antiplatelet therapy with this treatment would result in fewer
adverse events than would currently be expected in drug-eluting stent
patients."
"The additional positive 12-month results from the NEVO(TM) RES-I trial
are extremely encouraging as they suggest that NEVO(TM) could offer improved
patient outcomes in the treatment of coronary artery disease," said Campbell
Rogers, M.D., Chief Scientific Officer and Global Head, Research and
Development, Cordis Corporation. "NEVO(TM) is a critical component of our
commitment to providing innovative new products, which are transforming
expectations for patients and practitioners in the field of interventional
cardiology."
NEVO RES-I Study Overview
The NEVO(TM) RES-I study was a randomized, multi-center comparison of
NEVO(TM) to the Taxus(R) Liberte(R) Stent in de novo, native coronary artery
lesions. The study involved 394 patients at 40 sites throughout Europe, South
America, Australia and New Zealand. Patients underwent angiographic follow-up
at six months, received clinical follow-up at 30 days and six and 12 months,
and will be followed annually for the next five years. The primary endpoint
was in-stent late loss at six months. Key secondary endpoints include target
lesion failure, target vessel failure, MACE, stent thrombosis, target lesion
revascularization, target vessel revascularization, and angiographic in-stent
and in-segment binary restenosis at six months.
About NEVO(TM)
NEVO(TM), the first sirolimus-eluting stent utilizing RES TECHNOLOGY(TM),
is an open cell, thin strut, cobalt chromium design that incorporates
hundreds of small reservoirs filled with a recessed drug-polymer matrix. This
is designed to minimize polymer contact with the vessel wall at implant, and
allow transformation from a drug eluting stent into a bare metal stent in as
little as 90 days. Currently available drug-eluting stents have surfaces
completely coated in drug and a permanent polymer. Cordis submitted NEVO(TM)
for CE-marking in March 2010.
The NEVO(TM) Sirolimus-eluting Coronary Stent is an investigational
device. It is not approved or available for sale in any market.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson &
Johnson company, has been a worldwide leader in the development and
manufacture of interventional vascular technology. Through the company's
innovation, research and development, Cordis partners with interventional
cardiologists worldwide to treat millions of patients who suffer from
vascular disease.
In addition to his role as Primary Investigator, Dr. Abizaid is
compensated for his services as a member of the Company's scientific advisory
board and provides other consulting services.
*Cordis Corporation has entered into an exclusive worldwide license with
Wyeth for the localized delivery of sirolimus in certain fields of use,
including delivery via vascular stenting. Sirolimus, the active drug released
for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth,
under the name Rapamune(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
The third party trademarks used herein are trademarks of their respective
owners
Image: NEVO(TM) Sirolimus-eluting Coronary Stent
NOTE: Disclaimer needs to be used and placed next to image if you plan to
publish:
"NEVO(TM) Sirolimus-eluting Coronary Stent is an investigational device
exclusively for clinical investigations and is not approved for sale in any
market"
Subtitle image: NEVO(TM), the first drug-eluting stent utilizing RES
TECHNOLOGY(TM), incorporates hundreds of small reservoirs filled with a
recessed drug-polymer matrix.
Contact: Ulrike Domany Director Communication & Public Affairs, EMEA Mobile: +43-664-83-504-83 Office: +43-360-25-396
Contact: Ulrike Domany, Director Communication & Public Affairs, EMEA, Mobile: +43-664-83-504-83, Office: +43-360-25-396; A.J. Desjardins, Edelman, Mobile: +33-6-29-56-06-52, Office: +33-1-56-69-73-99
Tags: Cordis Corporation, France, May 25, Paris