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10.11.2004 – 18:25

Cordis Corporation

Study Shows Low Incidence of Adverse Events Associated With Cypher(R) Sirolimus-Eluting Coronary Stent

New Orleans, November 10 (ots/PRNewswire)

- Analysis of 30 Adverse Event Risk Factors Offers New Insights
for Patient Care
Data presented today at the 2004 American Heart Association
Scientific Sessions further documented the low incidence of Major
Adverse Cardiac Events (MACE) and stent thrombosis (blood clots)
associated with the CYPHER(R) Sirolimus-eluting Coronary Stent. The
overall MACE rate at six months for the drug-eluting stent was 3.1
percent in the 11,920 patients evaluated for the study, including men
and women of different ages and ethnicities and with varying health
status, including patients with diabetes.
MACE, which is a critical measurement of a drug-eluting stent's
safety and efficacy, is a composite endpoint that typically includes
such factors as target lesion revascularization (TLR, or the need for
retreatment), myocardial infarction (heart attack), and death
(all-cause mortality).
"These real-world clinical findings further support the
significant scientific evidence that exists regarding the CYPHER(R)
Stent. The results confirm an excellent safety profile of the
CYPHER(R) Stent in routine clinical use, similar to that shown in
randomized, controlled trials," said Philip Urban, MD, Director of
Invasive Cardiology, La Tour Hospital, Geneva, Switzerland. "When it
comes to any type of procedure, patient safety is always a primary
concern for doctors and patients, so it is reassuring that the
CYPHER(R) Stent is consistently demonstrating these positive results
over time. The preliminary efficacy data are also very encouraging,
even if a definitive assessment will have to wait until the 12-month
follow-up data that should be available early next year"
Results from the analysis of 11,920 patients showed TLR at 1.3
percent and 1.0 percent had suffered a myocardial infarction. The
aggregate stent thrombosis rate was 0.88 percent (0.13 percent acute
thrombosis, 0.61 percent sub-acute thrombosis and 0.14 percent late
thrombosis), which is comparable to conventional bare metal stents.
The study also examined 25 factors that could serve as predictors
of a patient's likelihood to experience an adverse event after
receiving a drug-eluting stent. Researchers looked at three main
categories: clinical factors (e.g., age, presence of diabetes),
lesion-specific factors (e.g., site of the lesion, such as in a
bifurcated or left main vessel, amount of calcification) and
procedure-specific factors (e.g., number of lesions, amount of
residual restenosis).
"We found that patients with stable chest pain correlated with a
decreased risk for adverse events, while factors such as insulin
dependent diabetes, advanced age, and a history of open heart surgery
showed a trend toward an increased risk of adverse events," Urban
said.
Dennis Donohoe, MD, Vice President of Clinical and Regulatory
Affairs at Cordis Corporation commented, "This study adds to the
growing body of evidence regarding the CYPHER(R) Stent's strong
safety profile, with new insight into factors that may impact patient
outcomes."
The analysis was based on six-month follow-up data from the
international e-CYPHER(SM) registry, which tracks use of the
CYPHER(R) Stent in more than 15,000 patients worldwide. The
e-CYPHER(SM) Registry has currently collected baseline, procedure and
follow-up information from 15,000 patients treated in 281 centers. An
independent review committee adjudicated all MACE events.
About the CYPHER(R) Stent
Developed and manufactured by Cordis Corporation, the CYPHER(R)
Stent is currently available in more than 80 countries and has been
used by doctors to treat more than 900,000 patients worldwide. With
more than 40 clinical trials conducted or in progress worldwide, the
CYPHER(R) Stent remains the most studied drug-eluting stent today
with the largest body of clinical evidence demonstrating the
long-term safety and efficacy of its drug and polymer. In clinical
trials, the CYPHER Stent has been shown to reduce reblockage in the
arteries by more than 90 percent over a bare metal stent.
About Cordis Corporation
For more than 40 years, Cordis Corporation, a Johnson & Johnson
company, has pioneered less invasive treatments for vascular disease.
Technological innovation and a deep understanding of the medical
marketplace and the needs of patients have made Cordis the world's
leading developer and manufacturer of breakthrough products for
interventional medicine, minimally invasive computer-based imaging,
and electrophysiology. Today, more than 7,000 Cordis employees
worldwide share a strong commitment to continue the Company's
groundbreaking work in the fight against 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.
Web site: http://www.cordis.com

Contact:

Terri Mueller, Cordis Corporation, +1-786-313-8687, or cell,
+1-305-903-9980; or Todd Ringler, Edelman, +1-212-704-4572, or cell,
+1-617-872-1235, for Cordis