News | November 04, 2007

Study Says Sirolimus-Eluting Stent Safety Similar to BMS at Five Years

November 5, 2007 - 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, according to data presented 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).

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

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 E-SIRIUS and C-SIRIUS trials 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 Corp. funded the New SIRIUS, C-SIRIUS and E-SIRIUS studies.

For more information: www.cypherstent.com

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