Largest Study to Date Shows Significant Reductions in Risks of Blood Clots and Reintervention With CYPHER(R) Sirolimus-Eluting Coronary Stent Compared to Taxus Stent
04/09/2007 17:47
PR Newswire
VIENNA, Austria, September 4 /PRNewswire/ -- In an extensive analysis of clinical trials known as a
meta-analysis, the CYPHER(R) Sirolimus-eluting Coronary Stent was associated
with significantly lower risks of blood clots and the need for reintervention
compared to the Taxus Stent out to 30 months after an angioplasty procedure.
This meta-analysis of 16 randomized clinical trials and 8,695 patients, the
largest analysis of its kind to date, is now posted on the Journal of the
American College of Cardiology website and is expected in print later in the
year.
"Over the past year, concerns have been raised regarding the
long-term safety of all drug-eluting stents," said Professor Albert Schömig,
M.D., from Deutsches Herzzentrum, Technische Universität in Munich, Germany,
one of the authors of the study. "In this meta-analysis of randomized
controlled trials, the CYPHER(R) Stent was associated with a significant
reduction in the risks of stent thrombosis and reintervention compared to the
Taxus Stent. This reinforces the notion that there are marked differences
between the CYPHER(R) Stent and the Taxus Stent and that the safety of these
drug-eluting stents must be assessed separately."
Professor Schömig added, "We find these data compelling
because they are consistent with other documented meta-analyses and reflect
data from all of the randomized clinical trials directly comparing these
drug-eluting stents. Meta-analyses like this are an important and
well-accepted statistical method among clinicians worldwide for documenting
similarities and differences between two treatment modalities. We understand
and appreciate that such studies are open to various interpretations by
researchers and clinicians."
The primary safety endpoint of the meta-analysis was
protocol-defined stent thrombosis while the secondary safety endpoints were
death and heart attack (myocardial infarction or MI). The primary efficacy
endpoint was the need for reintervention (target lesion revacularization or
TLR).
According to this comprehensive analysis of all head-to-head
clinical studies between the CYPHER(R) Stent and the Taxus Stent, a blood
clot (stent thrombosis) is 34 percent less likely to form in patients
implanted with the CYPHER(R) Stent than in patients who receive the Taxus
Stent-a statistically significant difference [hazard ratio (HR) 0.66, 95
percent confidence interval (CI) 0.46 to 0.94, p=0.02]. In addition, the
CYPHER(R) Stent significantly lowered the risk of reintervention by 26
percent versus the Taxus Stent (HR 0.74, CI 0.63 to 0.87, p
While the overall risk of death was not significantly
different between the two drug-eluting stents (HR 0.92, CI 0.74 to 1.13,
p=0.43), the authors of the meta-analysis identified a trend toward a lower
risk of heart attack with the CYPHER(R) Stent versus the Taxus Stent (HR
0.84, CI 0.69 to 1.03, p=0.10), especially after the first year of follow-up.
Events occurring after the first year of stent placement have
fueled the discussion surrounding the safety of drug-eluting stents. When
only patient-level data were used, the authors were able to assess the
occurrence of events after the first year of follow-up. In this analysis,
there was a significant 70 percent reduction in blood clots (p=0.004) and a
55 percent reduction in repeat heart attacks (p=0.006) in patients who
received the CYPHER(R) Stent compared to patients implanted with a Taxus
Stent.
"This meta-analysis substantially enriches the large body of
evidence that interventional cardiologists have at their disposal to make the
right choice for their patients," said Hans-Peter Stoll, M.D., Director of
Clinical Research and Medical Affairs for Cordis in Europe, the Middle East
and Africa "Drug-eluting stents, like the CYPHER(R) Stent, continue to
provide significant benefits for patients with coronary artery disease."
For this analysis of randomized controlled trials, the gold
standard of clinical evidence in medicine, individual patient data were
obtained from 11 of the 16 included studies or 5,562 patients. The authors
noted in the manuscript that the overall treatment effects were similar
regardless of how the data were analyzed (total patient population or
analysis of individual patient data).
The meta-analysis comprised studies of simple cases, studies
that included all types of patients and studies that focused on specific and
complex patient populations, such as patients with diabetes, patients treated
for disease in long lesions or small vessels, patients presenting with a
heart attack and patients being treated for repeat disease in a previously
placed bare-metal stent, some of which are not within the approved labeling
for the products.
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.
Contacts: Christopher Allman, Cordis Corporation, Mobile: +1-305-586-6024, Email: callman1@crdus.jnj.com; Terri Mueller, Office: +33-1-5500-4433, Mobile +33-6-2736-6588, Email: tmueller1@jnjfr.jnj.com