Atlanta,
GA (March 12, 2006) -- The CYPHER® Sirolimus-eluting
Coronary Stent reduced the risk of target vessel failure (TVF) by almost
half in patients who
suffered a heart attack (acute myocardial infarction or AMI) compared to those
who were treated with the current standard of care (balloon angioplasty
and a
bare metal stent), according to data presented today during a late-breaking
clinical trials session at the 2006 American College of Cardiology Scientific
Session.
At one year post implantation of the CYPHER® Stent, the study found that
patients given the CYPHER® Stent were 49 percent less likely to experience TVF
than those given a BMS. Specifically, patients in the CYPHER® Stent arm of the
study had a TVF rate of 7.3 percent compared to 14.3 percent in the BMS arm of
the study (p<0.004). TVF is a composite of the need for re-treatment (target
vessel revascularization or TVR), recurrent heart attack and death due to
cardiac reasons. In addition, the overall mortality rate in both the CYPHER®
Stent arm of the trial and the BMS group was exceeding low (2.2 percent in
both).
"The results of this trial provide important information for doctors treating
heart attack patients," said Christian Spaulding, M.D., F.A.C.C., professor of
Cardiology, Assistance Publique-Paris University Hospitals, Paris, France.
"Prior to the TYPHOON study, we did not have randomized clinical data to
understand the potential use of a drug-eluting stent during the acute phase of
a myocardial infarction.
"Now, doctors have results from a randomized study to help them evaluate the
potential role of the CYPHER® Stent in patients suffering an acute heart
attack."
TYPHOON (Trial to Assess the use of the CYPHER® Stent in Acute
Myocardial Infarction Treated with BallOON Angioplasty) is the first
randomized, multi-center clinical trial to study the safety and efficacy of
the CYPHER® Stent in patients who have suffered an AMI. Data were reported on
712 patients who had suffered an AMI within 12 hours before the stent
placement. TYPHOON was conducted 48 sites across Europe, Israel and Australia.
An angiographic sub-study was conducted in 210 patients who participated in
TYPHOON to assess the rate of re-blockage (restenosis) and the amount of
tissue proliferation (late loss) within the stent eight months after receiving
either a CYPHER® stent or the bare-metal control stent. The study found that
the CYPHER® Stent was associated with an 83 percent reduction in re-blockage
rates and an 83 percent reduction in late loss. Specifically, patients in the
CYPHER® Stent arm of the study had an in-stent restenosis rate of 3.5 percent
compared to 20.3 percent in the BMS arm of the study (p=0.0010) and an average
late loss of 0.14 mm compared to 0.83 mm in the BMS arm (p<0.0001).
Since patients receiving bare-metal stents for the treatment of heart attacks
are at an increased risk of stent thrombosis, there was initial concern about
the use of a drug-eluting stent in this patient population.
Through one-year follow-up in TYPHOON, the stent thrombosis rates with the
CYPHER® Stent (3.4 percent) and the bare metal stent (3.6 percent) arms of the
study were comparable (12 events in the CYPHER® Stent group vs. 13 events in
the group treated with bare metal stents).
"This study provides important clinical and angiographic evidence about the
potential role of the CYPHER® Stent in patients experiencing a heart attack,"
said Dennis Donohoe, M.D., worldwide vice president of Clinical Research and
Regulatory Affairs, Cordis Corporation. "With the TYPHOON data, our clinical
body of knowledge for the CYPHER® Stent continues to grow into new areas such
as acute myocardial infarction."
Cordis Corporation sponsored the TYPHOON trial.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more
than 1.7 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 40 studies, inclusive of independent clinical trials, 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. The first next generation
drug-eluting stent, the CYPHER® SELECT™ Sirolimus-eluting Coronary Stent, was
launched in Europe, Asia Pacific, Latin America and Canada in 2003. More
information about the CYPHER® Stent can be found at www.cypherusa.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson
company, is a worldwide leader in developing and manufacturing interventional
vascular technology. Through the
company's innovation, research and development, physicians worldwide are
better able to treat the 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®. Rapamune® is a trademark of Wyeth Pharmaceuticals.