Two-Year Outcomes From Large Head-To-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for CYPHER(R) Sirolimus-Eluting Coronary Stent and Taxus Stent


VIENNA, Austria, September 4 /PRNewswire/ --

- While no Significant Differences Were Found, Results Showed CYPHER(R) 
Stent had Numerically Lower Mortality and Heart Attack Rates

A subgroup analysis of diabetic patient data from a two-year
randomized controlled trial comparing the CYPHER(R) Sirolimus-eluting
Coronary Stent to the Taxus Stent showed no statistically significant
differences in safety outcomes between the two drug-eluting stents. The
authors of the analysis, presented today at the European Society of
Cardiology Congress 2007 (ESC Congress 2007), also reported that in the
CYPHER(R) Stent arm there were numerically lower rates of cardiac mortality,
blood clots and heart attack rates than in the Taxus Stent arm, although
these differences did not reach statistical significance.

"In this analysis of head-to-head randomized controlled trial
data, both drug-eluting stents yielded similar safety outcomes and the
CYPHER(R) Stent presented safety rates in some areas that were numerically
lower," said Giulio Guagliumi, M.D., from the Ospedale Riuniti Di Bergamo in
Bergamo, Italy, who presented the results on behalf of the REALITY Trial
investigators.

The cardiac death rates were 1.6 percent for the CYPHER(R)
Stent and 4.7 percent for the Taxus Stent (p=0.14). The rate of Q-wave
myocardial infarction (heart attacks that involve the full thickness of the
heart wall) was 0.0 percent for the CYPHER(R) Stent and 1.6 percent for the
Taxus Stent (p=0.25). In addition, the rates of non-Q wave myocardial
infarctions (heart attacks that do not involve the full thickness of the
heart wall) were 4.8 percent for the CYPHER(R) Stent and 5.2 percent for the
Taxus Stent (p=1.00). None of these numerical differences in favor of the
CYPHER(R) Stent reached statistical significance.

Both drug-eluting stents were also equivalent in terms of
major adverse cardiac events (MACE), which in this study were defined to
include cardiac deaths, Q-wave myocardial infarctions, non-Q wave myocardial
infarctions, emergent bypass surgery and target lesion revascularizations (a
subsequent procedure to reopen an artery). The MACE rate for the CYPHER(R)
Stent was 15.5 percent while the MACE rate for the Taxus Stent was 14.1
percent (p=0.77).

At the World Congress of Cardiology 2006, the REALITY Trial
investigators reported a stent thrombosis rate for the Taxus Stent that was
significantly higher than the rate for the CYPHER(R) Stent in the overall
patient population (2.5 percent for the Taxus Stent versus 0.9 percent for
the CYPHER(R) Stent; p log-rank=0.02). While the difference between the
protocol-defined stent thrombosis rate for each drug-eluting stent in the
diabetic patient subgroup did not reach statistical significance, the rate
for the Taxus Stent remained numerically higher than the rate for the
CYPHER(R) Stent (3.1 percent for the Taxus Stent versus 1.1 percent for the
CYPHER(R) Stent; p log-rank=0.16).

These numerically lower rates of cardiac death, Q-wave
myocardial infarction and stent thrombosis favoring the CYPHER(R) Stent were
also seen in diabetic patients who required insulin therapy.

"Diabetic patients remain one of the most complex patient
populations to treat for coronary artery disease," said Hans-Peter Stoll,
M.D., Director of Clinical Research and Medical Affairs for Cordis in Europe,
the Middle East and Africa. "This analysis provides additional and relevant
information to doctors regarding the long-term efficacy and safety outcomes
in diabetic patients treated with either the CYPHER(R) Stent or the Taxus
Stent."

The analysis involved 375 diabetic patients, which represented
28 percent of the patients enrolled in the REALITY Trial. The REALITY Trial
was comprised of 1,386 moderately complex patients from 90 centres in Europe,
Latin America and Asia. These patients were randomly selected to receive
either the CYPHER(R) Stent or the Taxus Stent. In the end, the CYPHER(R)
Stent was used in 684 patients and 970 artery blockages, while the Taxus
Stent was used in 669 patients and 941 artery blockages.

Cordis Corporation sponsored the REALITY Trial.

About the CYPHER(R) Stent

The CYPHER(R) Stent has been chosen by cardiologists worldwide
to treat approximately three 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 70 studies 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
broadest clinical experience and longest-term clinical follow-up of any
drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER
SELECT(TM) Sirolimus-eluting Coronary Stent, was launched in Europe, Asia
Pacific, Latin America and Canada in 2003. The CYPHER SELECT(TM) Plus Stent,
the third version of a sirolimus-eluting coronary stent, received CE Mark in
2006

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is 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.

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.

© PR Newswire Association LLC.

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