Healthcare Industry News: stent thrombosis
News Release - September 3, 2007
Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term SafetyVIENNA, Austria, Sept. 3 (HSMN NewsFeed) -- Clinical investigators at the European Society of Cardiology Congress 2007 (ESC Congress 2007) reported today that the CYPHER® Sirolimus-eluting Coronary Stent continued to provide clinical benefits compared to a bare metal stent in the E-SIRIUS Trial out to five years of follow-up with no differences in safety.
At five-year follow-up, the patients in the CYPHER® Stent arm of the study continued to be significantly less likely than the patients in the bare metal stent arm to need another procedure in the same arterial area (TLR or target lesion revascularization). In addition, the investigators found similar rates of myocardial infarction (heart attack) and mortality between the CYPHER® Stent and the bare metal stent, as well as no significant difference between their rates of stent thrombosis (blood clots).
"The five-year results of the E-SIRIUS Trial increase our knowledge and understanding of the long-term clinical benefits of the CYPHER® Stent for patients with coronary artery disease," said Erik Jorgensen, M.D., from The Heart Centre, University Hospital Rigshospitalet, Copenhagen, Denmark, the investigator who presented the results at the ESC Congress. "It is also important to note that at five years, the long-term safety of the CYPHER® Stent was comparable to the bare metal stent arm of this study, and this reinforces the existing body of evidence supporting the long-term safety and efficacy of the CYPHER® Stent."
The five-year results demonstrated that 5.1 percent of the patients in the CYPHER® Stent arm underwent another procedure in the same arterial area, compared to 20.9 percent of the patients in the bare metal stent arm of the study. This means that a patient in whom a CYPHER® Stent was implanted in this study was nearly 76 percent less likely to require a second procedure in the same arterial area within five years than a patient who was implanted a bare metal stent (p <0.001).
The study also showed both treatment arms to yield similarly low rates of mortality and myocardial infarction. The mortality rates were 8.6 percent for the CYPHER® Stent and 7.9 percent for the bare metal stent (p=0.850), the Q- wave myocardial infarction rate for each treatment arm was 1.1 percent (p=1.00) and the non-Q-wave myocardial infarction rates were 7.4 percent for the CYPHER® Stent and 5.1 percent for the bare metal stent (p=0.388).
Also importantly, the study did not find a significant difference in the rates of stent thrombosis between the CYPHER® Stent and the bare metal stent, regardless of whether protocol or Academic Research Consortium (ARC) definitions were employed. When the protocol definitions were used, the rates of acute and subacute stent thrombosis were 0.0 percent for the bare metal stent and 1.1 percent for the CYPHER® Stent (p=0.25). The late stent thrombosis rates were 0.0 percent for the bare metal stent and 1.7 percent for the CYPHER® Stent (p=0.12). The definite/probable ARC definition identified a stent thrombosis rate of 4.2 percent for the CYPHER® Stent versus 1.7 percent for the bare metal stent (p=0.199). The definite/probable/possible ARC definition yielded a stent thrombosis rate of 6.5 percent for the CYPHER® Stent versus 3.5 percent for the bare metal stent (p=0.216). While there were numeric differences in the timing of such events between the CYPHER® Stent and the bare metal stent, at no point throughout the five-year period were the differences statistically significant.
"The results presented today reaffirm the long-term clinical benefits of the CYPHER® Stent compared to bare metal stents," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "As previously announced, Cordis is expanding the E-SIRIUS Trial to eight years of follow-up to provide physicians with longer term data about the CYPHER® Stent that will assist them in making informed treatment decisions."
The E-SIRIUS trial is a double blind, multi-center, controlled, randomized trial designed to compare restenosis (re-blockage) rates between the CYPHER® Stent and a bare metal stent. It involved 352 patients from 35 European clinical centers. Patients enrolled in the study were considered to be at a moderate to high clinical risk for restenosis due to a previous heart attack or smoking.
The eight- and nine-month results of the E-SIRIUS Trial were published in Lancet in October 2003. Cordis Corporation funded the E-SIRIUS 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 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 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
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. More information about Cordis Corporation can be found at www.cordis.com.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Cordis' expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Cordis does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
*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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