September 5, 2007 - Clinical investigators at the European Society of Cardiology Congress 2007 (ESC Congress 2007) reported that the CYPHER Sirolimus-eluting Coronary Stent continued to provide clinical benefits compared to a bare metal stent in the E-SIRIUS Trial out to five years of follow-up with no differences in safety.
At the five-year follow-up, the patients in the CYPHER Stent arm of the 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 (TLR or target lesion revascularization). In addition, the investigators found similar rates of myocardial infarction (heart attack) and mortality between the CYPHER Stent and the bare metal stent, as well as no significant difference between their rates of stent thrombosis (blood clots).
“The five-year results of the E-SIRIUS Trial increase our knowledge and understanding of the long-term clinical benefits of the CYPHER Stent for patients with coronary artery disease,” said Erik Jorgensen, M.D., from The Heart Centre, University Hospital Rigshospitalet, Copenhagen, Denmark, the investigator who presented the results at the ESC Congress. “It is also important to note that at five years, the long-term safety of the CYPHER Stent was comparable to the bare metal stent arm of this study, and this reinforces the existing body of evidence supporting the long-term safety and efficacy of the CYPHER Stent.”
The five-year results demonstrated that 5.1 percent of the patients in the CYPHER Stent arm underwent another procedure in the same arterial area, compared to 20.9 percent of the patients in the bare metal stent arm of the study, meaning a patient who receives a CYPHER Stent implant in the study was nearly 76 percent less likely to require a second procedure in the same arterial area within five years than a patient who was implanted a bare metal stent (p
The study did not find a significant difference in the rates of stent thrombosis between the CYPHER Stent and the bare metal stent, regardless of whether protocol or Academic Research Consortium (ARC) definitions were employed. significant.
The E-SIRIUS trial is a double blind, multi-center, controlled, randomized trial designed to compare restenosis (re-blockage) rates between the CYPHER Stent and a bare metal stent. It involved 352 patients from 35 European clinical centers. Patients enrolled in the study were considered to be at a moderate to high clinical risk for restenosis due to a previous heart attack or smoking.The eight- and nine-month results of the E-SIRIUS Trial were published in Lancet in October 2003. Cordis Corporation funded the E-SIRIUS Trial.
For more information: www.cypherstent.com and www.cordis.com