Results from a multicenter, prospective, randomized clinical trial
indicate that the CYPHER(R) Stent performed better than the Taxus Stent
in procedures involving long coronary lesions, which are considered some
of the most complex blockages to treat with balloon angioplasty. The
final results from the LONG-DES-II Study were presented during a Late
Breaking Clinical Trial Plenary Session at the Transcatheter
Cardiovascular Therapeutics (TCT) Conference.
In this 500-patient trial, the CYPHER(R) Stent significantly
outperformed the Taxus Stent in the primary endpoint, which was binary
in-segment restenosis (a measure of reblockage) at six-month
angiographic follow-up. According to the data, 3.3 percent of the
patients who received a CYPHER(R) Stent developed binary in-segment
restenosis versus 14.6 percent of the patients who received a Taxus
Stent (p=0.001).
"The LONG-DES-II Study provides compelling evidence supporting
the use of the CYPHER(R) Stent in long coronary lesions," said
Seung-Jung Park, M.D., Ph.D., Principal Investigator of this study and
Chief of Interventional Cardiology, Asan Medical Center, Seoul, Korea.
"These results deserve attention as patients with very long lesions
are among the most difficult to treat and tend to be at higher risk of
restenosis."
At nine-month clinical follow-up, the CYPHER(R) Stent was found to
be significantly better than the Taxus Stent at reducing the need for a
second procedure. The rate of target lesion revascularization (TLR or
re-treatment in the same location) was 2.4 percent for the CYPHER(R)
Stent versus 7.2 percent for the Taxus Stent (p=0.012). The difference
in target vessel revascularization (TVR or re-treatment in the same
vessel) also reached statistical significance, with the CYPHER(R) Stent
registering a 3.2 percent rate and the Taxus Stent rate totaling 7.6
percent (p=0.03). It is also noteworthy that in this very challenging
population, device and procedural success were identical between the two
drug-eluting stents.
The study authors concluded that while efficacy rates in this study
favored the CYPHER(R) Stent over the Taxus Stent, the incidence of
death, myocardial infarction (heart attack) or stent thrombosis was
similarly low for both groups in a complex patient population with a
high prevalence of acute coronary syndrome.
The LONG-DES-II Study (percutaneous treatment of LONG native
coronary lesions with Drug-Eluting Stent-II) was conducted across five
medical centers in Korea and included 250 patients in the CYPHER(R)
Stent arm and 250 patients in the Taxus Stent arm. Lesion length needed
to be at least 25 mm. It is estimated that long lesions such as these
comprise approximately 20 percent of cases treated by interventional
cardiologists today.
"The LONG-DES-II Study adds to the growing body of data
helping interventional cardiologists to determine the best treatment
option for their patients," said Dennis Donohoe, M.D., vice
president, Worldwide Clinical and Regulatory Affairs, Cordis
Corporation. "Results of randomized controlled clinical trials like
the LONG-DES-II Study are the highest level of clinical evidence used to
compare medical therapies and have consistently demonstrated the
performance of the CYPHER(R) Stent."
Preliminary results of this trial were presented at the American
College of Cardiology's 55th Annual Scientific Session (ACC.06) in
March.
Cordis Corporation is one of the sponsors of the LONG-DES-II Study,
along with the Korean Ministry of Health and Welfare.
The CYPHER(R) Stent is indicated in the United States for improving
coronary luminal diameter in patients with symptomatic ischemic disease
due to discrete de novo lesions of length less than or equal to 30 mm in
native coronary arteries with a reference vessel diameter of less than
or equal to 2.5 to less than or equal to 3.5 mm.
About the CYPHER(R) Stent
More than 2 million worldwide patients with coronary artery disease
have been treated with the CYPHER(R) Stent. The safety and efficacy of
the device is supported by a robust clinical trial program that includes
more than 70 studies, inclusive of independent clinical trials, that
examine the performance of the CYPHER(R) Stent in a broad range of
patients.
Developed and manufactured by Cordis Corporation, the CYPHER(R)
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(TM) Stent, was
launched in Europe, Asia Pacific, Latin America and Canada in 2003. The
CYPHER SELECT(TM) Plus Stent, the first third-generation drug-eluting
stent, received the CE mark in June 2006 and is now available in many
markets outside the United States.
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(R).
Rapamune is a trademark of Wyeth Pharmaceuticals.
For more inforamtion, http://www.cordis.com or call 786/313-2776.
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