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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

vestigators found similar rates of freedom from major adverse cardiac and cerebrovascular events (MACCE) for the CYPHER(R) Stent and bypass surgery out to three years of follow-up. This finding is significant as MACCE -- comprised of death, stroke, myocardial infarction (heart attack) and the need for revascularization (re- treatment) of the blocked artery -- at one-year follow-up was the primary endpoint of the ARTS II Study. Specifically, 72.1 percent of the diabetic patients who received the CYPHER(R) Stent remained free of MACCE three years after the procedure, compared to 82.2 percent of the patients in the bypass surgery arm (p=0.09). Additionally, the CYPHER(R) Stent performed significantly better than the bare metal stent arm during the same endpoint, as 52.7 percent of the patients who received a bare metal stent did not experience a MACCE event after three years. The difference between the CYPHER(R) Stent arm and the bare metal stent arm reached statistical significance (p=0.0003).

Clinical investigators also reported no significant impact on MACCE when CYPHER(R) Stents were implanted in patients with blockages that measured more than 100 mm in length (20 percent of the ARTS II patient population). According to this subgroup analysis, 75.8 percent of these patients remained free of MACCE out to three years of follow-up, compared to 82.5 percent of the patients who received CYPHER(R) Stents measuring 100 mm or less in length (p =0.15).

A third analysis showed that implantation of the CYPHER(R) Stent in bifurcations did not affect clinical outcomes. The rate of freedom-from-MACCE for patients who received a CYPHER(R) Stent to treat a bifurcation (53.4 percent of the overall patient population) was 79.8 percent, compared to 81.5 percent when the implantation did not take place in a bifurcation (p=0.61). The clinical investigators also found that neither the type of bifurcation (true/substantial or partial) nor the stent implantation strategy (one-
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SOURCE Cordis Corporation
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