CYPHER® Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared To Bare Metal Stents In Five-Year Randomized Clinical Trial With No Differences In Long-Term Safety
Vienna, Austria .–Clinical investigators at the European Society of Cardiology Congress 2007 (ESC Congress 2007) reported today 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 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 Jørgensen, 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. This means that a patient in whom a CYPHER® Stent was implanted in this 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 0.001).
The study also showed both treatment arms to yield similarly low rates of mortality and myocardial infarction. The mortality rates were 8.6 percent for the CYPHER® Stent and 7.9 percent for the bare metal stent (p=0.850), the Q-wave myocardial infarction rate for each treatment arm was 1.1 percent (p=1.00) and the non-Q-wave myocardial infarction rates were 7.4 percent for the CYPHER® Stent and 5.1 percent for the bare metal stent (p=0.388).
Also importantly, 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. When the protocol definitions were used, the rates of acute and subacute stent thrombosis were 0.0 percent for the bare metal stent and 1.1 percent for the CYPHER® Stent (p=0.25). The late stent thrombosis rates were 0.0 percent for the bare metal stent and 1.7 percent for the CYPHER® Stent (p=0.12). The definite/probable ARC definition identified a stent thrombosis rate of 4.2 percent for the CYPHER® Stent versus 1.7 percent for the bare metal stent (p=0.199). The definite/probable/possible ARC definition yielded a stent thrombosis rate of 6.5 percent for the CYPHER® Stent versus 3.5 percent for the bare metal stent (p=0.216). While there were numeric differences in the timing of such events between the CYPHER® Stent and the bare metal stent, at no point throughout the five-year period were the differences statistically significant.
“The results presented today reaffirm the long-term clinical benefits of the CYPHER® Stent compared to bare metal stents,” said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. “As previously announced, Cordis is expanding the E-SIRIUS Trial to eight years of follow-up to provide physicians with longer term data about the CYPHER® Stent that will assist them in making informed treatment decisions.”
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.
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