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Four Analyses of Three-Year Clinical Data Suggest CYPHER(R) Sirolimus-Eluting Coronary Stent May Provide Alternative to Surgery for Patients with Multivessel Disease
Date:9/5/2007

or two-stent implantation) significantly influenced MACCE outcomes. The freedom- from-MACCE rate for true bifurcations was 81.9 percent, compared to 78.1 percent for partial bifurcations (p=0.58). The one-stent implantation strategy produced a freedom-from-MACCE rate of 82.0 percent, compared to 79.3 percent for the two-stent strategy (p=0.60). Bifurcations are associated with increased case complexity.

In addition, the ARTS II Study investigators reported stent thrombosis rates for the CYPHER(R) Stent using the ARC definitions. The definite, definite/probable and definite/probable/possible stent thrombosis rates for the CYPHER(R) Stent at three years were 3.3 percent, 5.3 percent and 6.4 percent, respectively. Stent thrombosis comparisons between the CYPHER(R) Stent and the bare metal stent were not possible as ARC stent thrombosis rates for the ARTS I Study were not available and the ARTS I Study did not track stent thrombosis rates beyond 30 days. The protocol stent thrombosis rate for the bare metal stent arm was 2.8 percent at 30 days of follow-up, while the ARC definite definite/probable and definite/probable/possible stent thrombosis rates for the CYPHER(R) Stent at 30 days were 1.0 percent, 1.5 percent and 1.5 percent, respectively.

In lieu of ARC stent thrombosis rates for the bare metal stent, the clinical investigators pointed out that the rate of myocardial infarction for the CYPHER(R) Stent was significantly lower than that of the bare-metal stent (3.6 percent for the CYPHER(R) Stent versus 6.8 percent for the bare metal stent, p=0.014). In addition, the mortality rate for the CYPHER(R) Stent was numerically lower than that of the bare metal stent, although this difference did not reach statistical significance (3.0 percent for the CYPHER(R) Stent versus 4.0 percent for the bare metal stent, p=0.33). These rates favored the CYPHER(R) Stent in spite of the fact that the patients treated with the drug- eluting stent were significantly more co
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SOURCE Cordis Corporation
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