Data from ESC confirms reduction in adverse events with CYPHER Stent

Additional Analysis of 18 Month Data of the SORT OUT III Trial Provides Detail on Safety and Efficacy Outcomes in Patients With Diabetes, Acute Coronary Syndrome, or Treatment of Multiple Lesions

Three new analyses of subgroups from the SORT OUT III study presented at the European Society of Cardiology (ESC) meeting in Stockholm, Sweden, provide additional detail on longer-term follow-up subgroup safety and efficacy outcomes in the SORT OUT III trial in three high-risk subgroups (diabetes, acute coronary syndrome and multiple lesion). These important data add detail to those already published in the March 2010 issue of The Lancet on the clinical outcomes for the primary endpoint in the total population and in multiple subgroups at 9 months follow-up and on clinical outcomes at 18 month follow up of the randomized comparison of the CYPHER(R) Stent and the Endeavor(R) Stent.

The initial results of the SORT OUT III study were published in the Lancet and showed significantly reduced adverse events at 9 and 18 months for the CYPHER(R) Sirolimus-eluting Coronary Stent over Medtronic's Endeavor(R) Stent in an unselected group of 2,332 patients undergoing coronary intervention in real world clinical practice. The authors reported that subgroup analysis of the primary endpoint of 9-month Major Adverse Cardiac Events (MACE, defined as a composite of cardiac death, myocardial infarction [MI], or target vessel revascularization [TVR]) were also consistent across all subgroups.

The new data from ESC provide important additional information on longer-term outcomes at 18 months in three key groups of patients that are at higher risk of adverse events when undergoing coronary intervention, namely patients with diabetes, acute coronary syndromes, and treatment of multiple lesions. These data confirm that the significant reductions in major adverse events in these subgroups seen at 9 months with the CYPHER Stent compared to the ENDEAVOR Stent were sustained through 18 months of follow-up and provide important details of how the components of MACE (death, MI, and TVR) contribute to the reduction in major adverse events.

Among the high-risk diabetic patient population in SORT OUT III, the incidence of MACE at 18 months was significantly reduced by 74% with CYPHER vs. ENDEAVOR (4.8% in the CYPHER Stent group vs. 18.3% in the Endeavor(R) Stent group; hazard ratio 4.05; 95% confidence intervals: 1.86-8.82). This difference was driven by statistically significant reductions in death, MI, TVR and TLR favoring the CYPHER Stent. In the CYPHER Stent group, the incidence of MACE was also significantly reduced by 46% compared to the ENDEAVOR Stent in patients without diabetes (4.5% in the CYPHER Stent group vs. 8.3% in the ENDEAVOR Stent group; hazard ratio 1.87, 95% confidence intervals: 1.30-2.69).

Among patients with acute coronary syndrome in SORT OUT III (defined as patients with unstable angina or myocardial infarction), the incidence of MACE at 18 months was significantly reduced by 43% with CYPHER vs. ENDEAVOR (5.0% in the CYPHER Stent group vs. 8.7% in the Endeavor(R) Stent group; hazard ratio 1.78; 95% confidence intervals: 1.10-2.88). This difference was driven by a statistically significant reduction in TLR and TVR favoring the CYPHER stent. In the CYPHER Stent group the incidence of MACE was also significantly reduced by 60% compared to the ENDEAVOR Stent in patients with stable angina (4.2% in the CYPHER Stent group vs. 10.4% in the ENDEAVOR Stent group; hazard ratio 2.53, 95% confidence intervals: 1.60-4.02).

Finally, among the high-risk group treated for disease in multiple lesions in SORT OUT III, the incidence of MACE at 18 months was significantly reduced by 80% with CYPHER vs. ENDEAVOR (2.6% in the CYPHER Stent group vs. 13.2% in the Endeavor(R) Stent group; hazard ratio 5.29; 95% confidence intervals: 2.59-10.8). This difference was driven by statistically significant reductions in death, MI, and TVR favoring the CYPHER Stent. In the CYPHER Stent group the incidence of MACE was also significantly reduced by 35% compared to the ENDEAVOR Stent in patients treated for disease in one lesion (5.4% in the CYPHER Stent group vs. 8.3% in the ENDEAVOR Stent group; hazard ratio 1.55, 95% confidence intervals: 1.06-2.27).

"The SORT OUT III subgroup analyses further support significant safety and efficacy differences between the CYPHER(R) Stent and the Endeavor(R) Stent," said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation and concludes, "In these data sets, risks of adverse events are up to five-fold higher with the Endeavor(R) Stent than with the CYPHER(R) Stent in patients with other complications like diabetes that are described in these data."