Healthcare Industry News: stent thrombosis
News Release - September 13, 2006
Study in New England Journal of Medicine Suggests Heart Attack Patients Fare Better with CYPHER(R) Sirolimus-eluting Coronary Stents Than Bare Metal StentsStudy is the First to Show Potential Benefits of a Drug-Eluting Stent in Patients Experiencing a Heart Attack
MIAMI, Sept. 13 (HSMN NewsFeed) -- 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 balloon angioplasty and a bare metal stent, according to data appearing today in the prestigious New England Journal of Medicine.
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 bare metal stent (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).
These data were originally presented at the American College of Cardiology annual scientific session in March 2006.
"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. "This study on the CYPHER® Stent is the first to show significant reductions in TVF in a multi-center, randomized clinical trial in patients experiencing a heart attack. 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. The TYPHOON trial was conducted at 48 sites across Europe, Israel and Australia.
An angiographic sub-study was conducted in 210 patients who participated in the TYPHOON trial 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 the TYPHOON trial, 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 two 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(TM) 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 http://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.
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