The SIRIUS (Sirolimus-coated BX VELOCITY Balloon-Expandable Stent in Treatment of Patients with De Novo Coronary Artery Lesions) trial is a double-blinded, multi-center, randomized study examining 1,058 patients with previously untreated (de novo) native coronary artery lesions. Data presented were four-year follow up of patients.
"Even after four years, the CYPHER® Stent continues to show impressive, sustained safety and efficacy benefits for a wide variety of patients and lesion types, without any evidence of 'late catch-up' in restenosis" said Martin Leon, M.D., Co-Principal Investigator of the SIRIUS trial. "These findings add to the extensive body of evidence supporting the use of the CYPHER® Stent as an excellent, long-term treatment for coronary artery blockages."
The study also found that the positive benefits of the CYPHER® Stent extended to patients at high-risk for re-blockage (restenosis). In fact, there was no 'late catch up' in restenosis in patients receiving the CYPHER® Stent compared to those receiving BMS. This had been a concern among clinicians since the introduction of drug-eluting stents in 2003.
"When the CYPHER® Stent was introduced four years ago, there was debate among interventional cardiologists as to whether we would see a late 'catch up' in restenosis relative to bare metal stents. The SIRIUS four-year data presented today show that those concerns are unfounded," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "The long-term data from the SIRIUS trial demonstrate that the CYPHER Stent provides durable, real-world benefits to patients."
Four-year data from the trial demonstrated that patients receiving the CYPHER® Stent had significantly lower rates of target vessel failure (TVF), the primary end-point of the trial, than those who received a BMS (18.6 percent for the CYPHER® Stent vs. 32 percent for BMS; p<0.001). TVF was defined as a composite of cardiac death, heart attack and re-treatment of the blocked vessel (target vessel revascularization or TVR).
The CYPHER® Stent arm of the study also demonstrated lower rates of repeat revascularization (target lesion revascularization or TLR) and major adverse cardiac events (MACE), including heart attack and death. There was a 67 percent reduction in TLR (7.9 percent for CYPHER® Stent vs. 23.8 for BMS; p<0.001) and 47 percent reduction in MACE (16.3 percent for CYPHER® Stent vs. 30.5 percent for BMS; p<0.001) for CYPHER® Stent patients. These figures are similar to what was noted during years 1-3 of this study. The late thrombosis rate was 0.8 percent in the CYPHER® Stent patients and 0.6 percent in the bare metal stent group after 4 years (p=1.000).
In the SIRIUS trial, patients were divided into two treatment groups: 533 patients received the CYPHER® Stent and 525 patients received a BMS (serving as the control arm of the study). Of the original participants, 94.2 percent of patients receiving the CYPHER Stent and 93.7 percent of patients receiving bare metal stents were available for the four-year follow up.
Cordis Corporation sponsored this trial.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than 1.7 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 40 studies, inclusive of independent clinical trials, 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 longest-term clinical follow-up of any drug-eluting stent. The first next generation drug-eluting stent, the CYPHER SELECT
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the 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.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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