Healthcare Industry News: stent thrombosis
News Release - March 26, 2007
CYPHER(R) Sirolimus-eluting Coronary Stent Had Similar Results to Bypass Surgery in Long-Term Study of Patients With Multi-Vessel Coronary Artery DiseaseNEW ORLEANS, March 26 (HSMN NewsFeed) -- Three-year follow-up data presented today at the American College of Cardiology's 56th Annual Scientific Session (ACC.07) showed that the CYPHER® Sirolimus-eluting Coronary Stent had results comparable to coronary artery bypass grafting (CABG or bypass surgery) in patients with blockages in two or more vessels, one of the most complex patient populations examined to date with any drug-eluting stent.
The Arterial Revascularization Therapy Study II (ARTS II Study) is an extension of the ARTS I Study, which was conducted in 1997 and compared the results of bare-metal stents (BMS) to those obtained with bypass surgery. Sponsored by Cordis Corporation, the ARTS II Study includes 607 patients from 45 European centers treated with the CYPHER® Stent. Investigators compared the findings for these patients to those from the ARTS I Trial, which included 605 patients treated with bypass surgery and 600 treated with a BMS.
After three years of patient follow-up, the ARTS II Study continued to show similar rates of survival from major adverse cardiac and cerebrovascular events (MACCE) for the CYPHER® Stent and bypass surgery. This finding is significant as MACCE -- comprised of death, stroke, myocardial infarction (heart attack) and the need for revascularization (re-treatment) of the blocked artery -- was the primary endpoint of the ARTS II Study, which was designed to assess whether the CYPHER® Stent was as effective as bypass surgery.
"Physicians are continuing to evaluate how to best treat and improve the quality-of-life of patients with multi-vessel coronary artery disease," said Patrick W. Serruys, M.D., Ph.D., from Thoraxcenter, Erasmus Medical Center in The Netherlands, and the presenter of the findings today at ACC.07. "The ARTS II three-year data suggest that percutaneous procedures using the CYPHER® Stent provided similar results to bypass surgery in these patients and are much less invasive."
Specifically, 80.6 percent of the patients who received the CYPHER® Stent remained free of MACCE, compared to 83.8 percent of the patients in the bypass surgery arm. Additionally, the CYPHER® Stent performed considerably better than the BMS arm in the same endpoint, as 66.0 percent of the patients who received a BMS did not experience a MACCE event after three years. The difference between the CYPHER® Stent arm and the BMS arm reached statistical significance (p<0.001).
The severe event rate (a composite for death, stroke and heart attack) for the CYPHER® Stent was compared with both the bypass surgery and BMS. The three-year follow-up data showed that 92.0 percent of the patients who received the CYPHER® Stent had survived and had not experienced a stroke or a heart attack, compared with 89.1 percent of the patients in the bypass surgery arm and 87.2 percent of the patients in the BMS arm. The difference between the CYPHER® Stent arm and the BMS arm reached statistical significance (p=0.004).
"More than 25 years ago, balloon angioplasty transformed the treatment paradigm for patients with coronary artery disease," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Cardiology Division of Cordis Corporation. "The three-year results of the ARTS II Study indicated that balloon angioplasty combined with the CYPHER® Stent was as good a treatment as bypass surgery and provided better outcomes than BMS implantation in patients with multi-vessel disease."
The ARTS II Study investigators also reported stent thrombosis rates using the Academic Research Consortium (ARC) definition. The definite stent thrombosis rate for the CYPHER® Stent at 30 days was 1 percent, lower than the 2.8 percent rate found in the BMS arm. The cumulative rates of definite and definite/probable stent thrombosis for the CYPHER® Stent at three-year follow-up were 3.3 percent and 5.3 percent, respectively. Three-year stent thrombosis comparisons with the BMS arm were not possible, as the ARTS I Study did not track stent thrombosis rates beyond 30 days.
The CYPHER® Stent does not have an approved indication in the United States for patients with multi-vessel disease.
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.
*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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