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.
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 randomised clinical trials shows that the Cypher Stent has an impressive safety and efficacy profile compared to bare metal stents, and that this favourable profile is sustained over time," said David E. Kandzari, 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 eight percent of the patients in the Cypher Stent arm underwent another percutaneous procedure in the same arterial area, compared to 25.1 per cent of the patients in the bare metal stent arm of the study. Additionally, 1.8 per cent of Cypher Stent patients underwent bypass surgery as the repeat procedure versus 2.6 per cent of patients in the bare metal stent arm.
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 per cent for the Cypher Stent and 7.5 per cent for the bare metal stent. The Q-wave myocardial infarction rate was 3.1 per cent for the Cypher Stent and 1.8 per cent for the bare metal stent (p=0.38) and the non-Q-wave myocardial infarction rates were 7.6 per cent for the Cypher Stent and 5.7 per cent for the bare metal stent.
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 per cent for the Cypher Stent and 0.9 per cent for the bare metal stent. The probable ARC definition identified a stent thrombosis rate of 1.3 per cent for each treatment arm. The possible ARC definition provided a stent thrombosis rate of 2.2 per cent for the Cypher Stent versus 1.3 per cent for the bare metal stent. The definite/probable/possible ARC definition yielded a stent thrombosis rate of 6.2 per cent for the Cypher Stent versus 3.5 per cent for the bare metal stent.
"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-centre, controlled, randomised 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 centres and the C-SIRIUS trial involved 100 patients from eight Canadian clinical centres. Cordis Corporation funded the New SIRIUS, C-SIRIUS and E-SIRIUS studies.
The Cypher Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than 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.
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.
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.