Positive Long Term Data Presented at ACC 2010 Demonstrate Sustained Safety and Efficacy Advantages of the Cypher(R) Sirolimus Drug-Eluting Stent Over the Endeavor(R) Zotarolimus-Eluting Stent

By Cordis Corporation, PRNE
Tuesday, March 16, 2010

SORT OUT III Data Presented at American College of Cardiology Meeting in Atlanta and Published in the Lancet

WATERLOO, Belgium, March 17, 2010 - Investigators reported the long-term follow-up of the
largest randomized comparison between the CYPHER(R) Sirolimus-eluting
Coronary Stent and Medtronic's Endeavor(R) Stent highlighting significant and
sustained clinical differences. These important findings were presented at
the American College of Cardiology annual meeting, (ACC 2010) in Atlanta and
published on-line in the prestigious journal The Lancet. The CYPHER(R) Stent
was associated with significantly lower rates of death, myocardial infarction
(heart attack), and repeat revascularization (the need for another procedure)
than the Endeavor(R) Stent out to 18 months. This study adds to the unmatched
body of safety and efficacy data on the CYPHER(R) Stent with this comparison
to the more recently approved Endeavor(R) Stent in a contemporary setting.

The large randomized trial SORT OUT III included more than 2,300 patients
across a wide range of lesion and patient complexity. The investigators
reported that the mortality rate (4.4% for Endeavor(R) vs. 2.7% for
CYPHER(R): p<0.035), incidence of heart attacks (2.1% for Endeavor(R) vs. 0.9
% for CYPHER(R): p<0.029), and composite endpoint of MACE (9.7 % for
Endeavor(R) vs. 4.5 % for CYPHER(R): p<0.0001) was significantly lower in
patients receiving CYPHER(R) compared to those receiving Endeavor(R). The
incidence of "definite" late stent thrombosis was higher for Endeavor(R) than
for CYPHER(R), but this difference was not statistically significant (1.1%
for Endeavor(R) vs. 0.5% for CYPHER(R): p<0.13). Coupled with the safety
advantage observed with CYPHER(R), there was an efficacy advantage as well:
CYPHER(R) had significantly less frequent ischemia-driven target lesion
revascularization through 18 months compared to Endeavor(R) (1.7% for
CYPHER(R) vs. 6.1% Endeavor(R): p<0.0001).

"The SORT OUT III data highlight the excellent long-term safety and
efficacy data of the CYPHER(R) Stent in a broad range of patients, and
further show that there are important safety and efficacy differences between
drug-eluting stents, in this case the CYPHER(R) Stent and the Endeavor(R)
Stent," said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global
Research and Development, Cordis Corporation. "The superior safety and
efficacy of the CYPHER(R) Stent compared to the Endeavor(R) stent in this
real-world randomized study reinforce the excellent sustained clinical
outcomes consistently seen over the last 10 years. There now have been six
different sets of data from randomized clinical trials and
registries–Endeavor III, SORT OUT III, ZEST, ISAR TEST II, the SCAAR
diabetes data and the Western Denmark Registry-in which the CYPHER(R) Stent
outperformed the Endeavor(R) Stent in key outcome measures, including in long
term follow-up," Dr. Rogers noted.

Dr. Jens Flensted Lassen, Principal Investigator of the SORT OUT III
trial and associate professor at the Department of Cardiology, Aarhus
University Hospital in Denmark pointed to the fact that
two main characteristics of the SORT OUT III trial could have caused the
difference: the SORT OUT trial was an all-comer trial that accepted nearly
all patients receiving a drug-eluting stent, and it was powered to assess
clinical endpoints. "If you want to assess clinically relevant differences
between the various drug-eluting stents, you have to compare the stents in
routine clinical care patients," Dr. Jens Flensted Lassen noted. "As an
example the Endeavor III was performed in 436 low-risk patients with a single
non-complex lesion and was only powered to assess an angiographic endpoint.
SORT OUT III randomized 2,332 all-comers and was powered to assess a clinical
endpoint." Another characteristic of the SORT-OUT III trial was the use of
Danish health registries to detect clinical events during follow-up. "This
means that only clinical events which were seriously enough to bring the
patient in contact with the health care system were detected and thereby
bringing the results more in line with what is seen in daily clinical
practice . Furthermore, the results were unaffected by biases since there
were no direct patient contact and no angiographic follow up during the
study", Dr. Lassen stated.

"We continue to be gratified by the outstanding performance of CYPHER(R)
compared with other drug-eluting stents. The breadth of clinical safety and
efficacy data and the long-term follow-up data on patient outcomes associated
with the CYPHER(R) Stent are unmatched by the competition, and this gap
continues to widen," Dr. Rogers concluded.

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.

For more complete information on indications, contraindications, warnings
and precautions, see the Instructions for Use available at
www.cypherstent.com.

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. More information about Cordis Corporation can
be found at www.cordis.com.

*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.

Media Contact: Ben Lyons, +44(0)20-7526-3622 office

Media Contact: Ben Lyons, +44(0)20-7526-3622 office, +44(0)78-1425-0038

YOUR VIEW POINT
NAME : (REQUIRED)
MAIL : (REQUIRED)
will not be displayed
WEBSITE : (OPTIONAL)
YOUR
COMMENT :