Atlanta, GA (March 12, 2006) -- Data from a multi-center, prospective
randomized controlled clinical trial suggests that the CYPHER®
Sirolimus-eluting Coronary Stent outperformed the Taxus Stent in procedures
involving long coronary lesions, which are considered some of the most complex
blockages to treat with angioplasty. The results from the LONG DES-II Study
were presented here today at the American College of Cardiology Conference
Annual Scientific Session.
The LONG DES-II Study (percutaneous treatment of long native coronary lesions
with Drug-Eluting Stents II) was designed to compare the angiographic
in-segment binary restenosis rate of CYPHER® Stent vs. the Taxus Stent at six
months. The study was conducted across five medical centers in Korea and
included 500 patients (250 in the CYPHER® Stent arm and 250 in the Taxus Stent
arm). Lesion length needed to be > 25 mm. It is estimated that long
lesions such as these comprise approximately 20 percent of cases treated by
interventional cardiologists today.
"In this study, the CYPHER® Stent showed better outcomes than the Taxus Stent
in these complex, long lesions. Patients with very long lesions are among the
most difficult to treat and tend to be at higher risk of restenosis," said
Seung-Jung Park, M.D., Ph.D., FACC, principal investigator of this study and
Chief of Interventional Cardiology, ASAN Medical Center, Seoul, Korea. "These
findings provide important new information for clinicians to consider when
choosing the best treatment for these types of complex patients."
Myeong-Ki Hong, M.D., PhD., associate professor of Medicine, Division of
Cardiology, Department of Internal Medicine, University of Ulsan, College of
Medicine, Seoul, Korea, presented the findings today on Dr. Park's behalf. The
ASAN Medical Center is the teaching affiliate hospital of Ulsan University,
also in Korea.
In this study, the patients received a mean total stent length of about 41 mm.
Patients receiving the CYPHER® Stent had significantly less in-stent late loss
than patients treated with the Taxus Stent (0.05±0.22 loss index for the
CYPHER® Stent vs. 0.25±0.35 loss index for the Taxus Stent; p<0.001) and 71
percent less in-segment restenosis than patients treated with the Taxus Stent
(three percent for the CYPHER® Stent vs. 10.3 percent for the Taxus Stent;
p=0.007).
Additionally, patients treated with the CYPHER® Stent had significantly larger
minimal in-stent diameter (vessel opening) at follow-up than patients treated
with the Taxus Stent (2.39±0.46 mm for the CYPHER® Stent vs. 2.04±0.65 for the
Taxus Stent; p<0.001), which is important for blood flow, and a lower average
in-stent diameter stenosis (blockage) than those treated with the Taxus Stent
(13.0±17.8 percent for the CYPHER® Stent vs. 23.6±20.7 percent for the Taxus
Stent; p<0.001) at late follow-up.
Secondary endpoints included in-segment and in-stent restenosis at six months
as well as Major Adverse Cardiac Events (MACE), an important safety and
efficacy outcome measure which comprises all-cause death, myocardial
infarction (heart attack) and target lesion revascularization (TLR or
retreatment). At the nine-month clinical follow-up, MACE rates were three
percent for the CYPHER® Stent versus 7.8 percent for the Taxus Stent (p=0.027).
"The LONG DES-II trial provides additional clinical evidence that continues to
differentiate the CYPHER® Stent from the Taxus Stent," said Dennis Donohoe,
M.D., vice president, Worldwide Clinical and Regulatory Affairs, Cordis
Corporation.
"Results of randomized controlled clinical trials, like this LONG DES-II
Study, are the highest level of clinical evidence used to compare two
products. To date, in every randomized clinical trial comparing angiographic
follow up of the CYPHER® Stent to the Taxus Stent, the CYPHER® Stent has
demonstrated a significant difference in important angiographic measurements.
Furthermore, in multiple meta-analyses of these trials, the CYPHER® Stent has
demonstrated significant differences in important clinical outcomes, such as
target lesion revascularization. The clinical body of knowledge for the
CYPHER® Stent continues to show impressive and sustained clinical outcomes for
patients and physicians."
About the CYPHER® Stent
The CYPHER® Stent has been
chosen by cardiologists worldwide to treat more than 1.7 million patients
with coronary artery disease. The safety and
efficacy of the device is supported by a robust clinical trial program that
includes more than 40 studies, inclusive of independent clinical trials, that
examine the performance of the CYPHER® Stent in a broad range of patients.
Developed and manufactured by Cordis Corporation, the CYPHER® Stent is
currently available in more than 80 countries and has the longest-term
clinical follow-up of any drug-eluting stent. The first next generation
drug-eluting stent, the CYPHER® SELECT™ Sirolimus-eluting Coronary
Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003.
More
information about the CYPHER® Stent can be found at www.cypherusa.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson
company, is a worldwide leader in developing and manufacturing interventional
vascular technology. Through the
company's innovation, research and development, physicians worldwide are
better able to treat the millions of patients who suffer from vascular disease.
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®. Rapamune® is a trademark of Wyeth Pharmaceuticals.