Healthcare Industry News: drug-eluting stent
News Release - November 5, 2007
Pooled Analysis of Long-Term Data Suggests Cypher(R) Sirolimus-Eluting Coronary Stent Provides Sustained Clinical Benefits in Patients with Coronary Artery Disease Compared to Bare Metal StentsORLANDO, Fla.--(HSMN NewsFeed)--A pooled analysis of the E-SIRIUS and C-SIRIUS trials, called New SIRIUS, found that the CYPHER® Sirolimus-eluting Coronary Stent continued to provide clinical benefits with similar safety compared to a bare metal stent at five-year follow-up. The data are being presented today at the American Heart Association Scientific Session 2007.
At five-year follow-up, the patients in the CYPHER® Stent arm of the New SIRIUS 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 (target lesion revascularization). In addition, the investigators found similar rates of myocardial infarction (heart attack) and mortality with the CYPHER® Stent and the bare metal stent, and no significant difference in the rates of stent thrombosis (blood clots).
“The pooled analysis of these two randomized clinical trials shows that the CYPHER® Stent has an impressive safety and efficacy profile compared to bare metal stents, and that this favorable profile is sustained over time,” said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. “Follow-up on patients in the E-SIRIUS and C-SIRIUS trials will continue out to eight years so that we can learn more about the long-term benefits of the CYPHER® Stent.”
According to the New SIRIUS analysis presented, patients who received a CYPHER® Stent were less likely to require a second procedure – bypass surgery or percutaneous intervention – in the same arterial area within five years than a patient who was implanted with a bare metal stent. The five-year results demonstrated that 8.0 percent of the patients in the CYPHER® Stent arm underwent another percutaneous procedure in the same arterial area, compared to 25.1 percent of the patients in the bare metal stent arm of the study (p < 0.001). Additionally, 1.8 percent of CYPHER® Stent patients underwent bypass surgery as the repeat procedure versus 2.6 percent of patients in the bare metal stent arm (p=0.75).
The New SIRIUS study also showed that both treatment arms yield similarly low rates of mortality and myocardial infarction. The mortality rates were 7.6 percent for the CYPHER® Stent and 7.5 percent for the bare metal stent (p=1.00). The Q-wave myocardial infarction rate was 3.1 percent for the CYPHER® Stent and 1.8 percent for the bare metal stent (p=0.38) and the non-Q-wave myocardial infarction rates were 7.6 percent for the CYPHER® Stent and 5.7 percent for the bare metal stent (p=0.46).
The New SIRIUS study did not find a significant difference in the rates of stent thrombosis between the CYPHER® Stent and the bare metal stent when using any of the Academic Research Consortium (ARC) definitions. The definite ARC definition yielded a stent thrombosis rate of 2.7 percent for the CYPHER® Stent and 0.9 percent for the bare metal stent (p=0.174). The probable ARC definition identified a stent thrombosis rate of 1.3 percent for each treatment arm (p=1.000). The possible ARC definition provided a stent thrombosis rate of 2.2 percent for the CYPHER® Stent versus 1.3 percent for the bare metal stent (p=0.502). The definite/probable/possible ARC definition yielded a stent thrombosis rate of 6.2 percent for the CYPHER® Stent versus 3.5 percent for the bare metal stent (p=0.197).
“The body of clinical evidence supporting the CYPHER® Stent continues to grow, making it the most studied drug-eluting stent with the greatest body of long-term data,” said Dr. Kandzari. “These data are meaningful for clinicians seeking to determine if a drug-eluting stent is a viable option for their patients, and underscores the continued benefits associated with a CYPHER® Stent.”
The E-SIRIUS and C-SIRIUS trials are two of the longest-running studies comparing the safety and efficacy of a drug-eluting stent to a bare metal stent. The studies are double-blind, multi-center, controlled, randomized trials designed to compare in-stent minimal lumen diameter and restenosis (re-blockage) rates between the CYPHER® Stent and a bare metal stent. The E-SIRIUS trial involved 352 patients from 35 European clinical centers and the C-SIRIUS trial involved 100 patients from eight Canadian clinical centers. Cordis Corporation funded the New SIRIUS, C-SIRIUS and E-SIRIUS studies.
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.
- 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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