Healthcare Industry News: stent thrombosis
News Release - October 21, 2007
New Study Shows Excellent Outcomes for CYPHER(R) Sirolimus-Eluting Coronary Stent in Treatment of Completely Blocked Coronary ArteriesSix-month Results from ACROSS-CYPHER Study Presented at TCT 2007
WASHINGTON--(HSMN NewsFeed)--Implantation of the CYPHER® Sirolimus-eluting Coronary Stent to treat completely blocked coronary arteries led to substantial reductions in recurrent blockage and the need for repeat treatment compared to bare metal stents in a study presented today at the Transcatheter Cardiovascular Therapeutics 2007 meeting (TCT 2007).
Researchers reported that the Approaches to Chronic Occlusions with Sirolimus-eluting Stents (ACROSS-CYPHER) study met its primary endpoint, which was the assessment of angiographic restenosis at six-month follow-up. Among 200 patients treated with the CYPHER® Stent following successful reopening of a completely blocked coronary artery (chronic total occlusion), the likelihood of renarrowing of the treated segment (angiographic restenosis) was reduced by 65.6 percent compared with a pre-specified cohort of patients treated with a bare metal stent in the earlier Total Occlusion Study of Canada (TOSCA-1) trial. In the entire segment treated with balloon angioplasty and stents, the restenosis rate for the CYPHER® Stent was 19.0 percent while the restenosis rate for the bare metal stent was 55.2 percent. Following risk adjustment, these differences translated into an 84 percent reduction in the primary endpoint (p<0.0001). Further, restenosis occurring only within the CYPHER® Stent-treated area was 7.5 percent.
“Chronic total occlusions remain one of the most challenging lesions to treat, especially because rates of restenosis and reocclusion have remained high despite treatment with bare metal stents,” said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation, who presented the results. “These data, combined with the results of the PRISON II Randomized Controlled Trial, which showed similar positive results for the CYPHER® Stent in chronic total occlusions, add to the unsurpassed volume of clinical evidence on the use of the CYPHER® Stent in a variety of patients and lesion subsets, including these very complex, chronically occluded vessels.”
Among patients treated with the CYPHER® Stent, at six months, there were no deaths, and myocardial infarction and target lesion revascularization occurred in 1.0 percent and 6.0 percent of patients, respectively. Overall major adverse cardiac events were similarly low, at 6.5 percent.
The reported stent thrombosis rate for the CYPHER® Stent was 0.0 percent within 24 hours after stent implantation, 0.0 percent between 1 and 30 days after stent implantation; and 0.5 percent beyond 30 days after stent implantation.
The ACROSS-CYPHER Trial is a prospective, multi-center, open-label, single-arm study designed to demonstrate the safety and efficacy of the CYPHER® Stent in non-acute chronic total occlusions. The study included patients from 15 medical centers in the United States and Canada.
Dr. Kandzari is one of the principal investigators of the Cordis-sponsored study. Enrollment and six-month follow-up were completed before Dr. Kandzari joined Cordis. At the time, Dr. Kandzari was part of the faculty at Duke University Medical Center.
In the United States, the CYPHER® Stent is indicated for de novo lesions less than 30 mm in length in native coronary arteries between 2.5 mm and 3.5 mm in diameter. It does not have an approved indication for patients with chronic total occlusions.
About the CYPHER® Stent
The CYPHER® Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than 3 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.
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 a sirolimus-eluting stent, the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT™ 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, 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.
(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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