In Patients with Heart Attacks, CYPHER® Sirolimus-Eluting Coronary Stent Results Sustained out to Four Years Compared to Bare Metal Stents

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Tue May 19, 2009 10:45am EDT

BARCELONA, Spain--(Business Wire)--
Four-year results of a large, multi-center clinical trial show that earlier
results favoring the CYPHER® Sirolimus-eluting Coronary Stent over bare metal
stents (BMS) in patients with acute myocardial infarction (heart attack) were
maintained in long-term follow-up. In addition, there were no differences in key
safety measures between the CYPHER® Stent and BMS. 

Results were presented today during Late Breaking Clinical Trials at EuroPCR 09,
the leading medical conference in Europe for physicians specializing in
interventional procedures. 

The study found that, four years after implantation, patients receiving the
CYPHER® Stent remained 53 percent less likely to experience target lesion
revascularization (TLR) than those receiving a BMS. Specifically, patients in
the CYPHER® Stent arm of the study had a TLR rate of 7.2 percent compared to
15.2 percent in the BMS arm of the study (p=0.005). The reduction of target
vessel revascularization (TVR) by the CYPHER® Stent was also maintained with 44
percent reduction at four years (9.6 percent in the CYPHER® Stent arm versus
17.2 percent in the BMS arm; p=0.013). 

"The four-year results of this trial, especially the highly significant
reduction in TVR, are impressive because of the sustained benefits seen in these
patients receiving the CYPHER® Stent," said Christian Spaulding, M.D., F.A.C.C.,
Professor of Cardiology, Assistance Publique-Paris Decartes University
Hospitals, Paris, France. "These results will be helpful to physicians as they
assess treatment options for patients having an acute heart attack." 

There continued to be no differences in the key safety parameters of cardiac
death, heart attack or stent thrombosis in the four-year follow-up (death=4.0
percent for the CYPHER® Stent vs. 6.4 for BMS). 

Prior to TYPHOON, there were insufficient randomized clinical data available to
evaluate the safety of a drug-eluting stent during the acute phase of a heart
attack. There were numerous clinical trial data assessing the safety of bare
metal stents in these patients. At four years, there were no differences in
rates of ARC (Academic Research Consortium)-defined definite/probably stent
thromboses between the two treatment arms (4.8 percent for the CYPHER® Stent vs.
4.4 percent for bare metal stents; p=0.83). 

"The safety outcomes for the CYPHER® Stent in this complex patient population
were similar to what we have seen in the BMS arm," said Dr. Spaulding. 

"This study provides important evidence about the long-term performance of the
CYPHER® Stent in patients experiencing a heart attack, which represents a
significant percentage of patients who undergo emergency angioplasty," said
Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research &
Development, Cordis Corporation. "With the TYPHOON data, the long-term clinical
body of knowledge in complex patient populations for the CYPHER® Stent continues
to grow." 

In August 2008, CYPHER SELECT® Plus, which is available outside the United
States and Japan, received CE marking for treatment of acute myocardial
infarction. The CYPHER® Stent is not approved for the treatment of AMI in the
U.S. 

About TYPHOON

TYPHOON (Trial to Assess the use of the CYPHER® Stent in Acute Myocardial
Infarction Treated with BallOON Angioplasty) is the first large, randomized,
multi-center clinical trial to study the safety and efficacy of the CYPHER®
Stent in patients who have suffered a heart attack. 

TYPHOON was closed in 2006 after 1-year of follow-up by study design. However,
because of concerns of stent thrombosis at that time, the trial was re-opened in
2007 to ascertain four-year follow-up data. TYPHOON was conducted 48 sites
across Europe, Israel and Australia. 

The one-year data were presented originally at the American College of
Cardiology annual scientific session in March 2006 and were published later that
year in the New England Journal of Medicine. 

In addition to his role as the lead investigator, Dr. Spaulding is compensated
for his time as a member of Cordis` scientific advisory board. 

Cordis Corporation sponsored the TYPHOON trial. 

About the CYPHER® Stent

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

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. 

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®. Rapamune is a trademark of Wyeth Pharmaceuticals. 

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Cordis Corporation
Christopher Allman
(m) 305-586-6024
(o) 908-541-4807
Callman1@its.jnj.com

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