Long-Term Data Supports Cypher Over Endeavor in High-Risk Subgroups

 

September 7, 2010

September 7, 2010 – New analyses of subgroups from the SORT OUT III study provide detail on longer-term follow-up safety and efficacy outcomes in diabetics and patients with acute coronary syndrome and multiple lesions.Three new analyses of subgroups were presented at the European Society of Cardiology (ESC) meeting last week in Stockholm. 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 nine months followup and on clinical outcomes at 18-month followup of the randomized comparison of the Cypher stent and the Endeavor stent.

The initial results of the SORT OUT III study showed significantly reduced adverse events at nine and 18 months for the Cypher sirolimus-eluting coronary stent over Medtronic's Endeavor zotarolimus-eluting 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 nine-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 nine months with the Cypher compared to the Endeavor were sustained through 18 months of followup and provide important details of how the components of MACE contribute to the reduction in major adverse events.

Diabetics

Among the high-risk diabetic patient population in SORT OUT III, the incidence of MACE at 18 months was significantly reduced by 74 percent with Cypher vs. Endeavor (4.8 percent in the Cypher group vs. 18.3 percent in the Endeavor group; hazard ratio 4.05; 95 percent 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 group, the incidence of MACE was also significantly reduced by 46 percent compared to the Endeavor in patients without diabetes (4.5 percent in the Cypher group vs. 8.3 percent in the Endeavor group; hazard ratio 1.87, 95 percent confidence intervals: 1.30-2.69).

Coronary Syndromes

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 reduced by 43 percent with Cypher vs. Endeavor (5 percent in the Cypher group vs. 8.7 percent in the Endeavor group; hazard ratio 1.78; 95 percent confidence intervals: 1.10-2.88). This difference was driven by a statistically significant reduction in TLR and TVR favoring the Cypher. In the Cypher group the incidence of MACE also was reduced by 60 percent compared to the Endeavor stent in patients with stable angina (4.2 percent in the Cypher group vs. 10.4 percent in the Endeavor group; hazard ratio 2.53, 95 percent confidence intervals: 1.60-4.02).

Multiple Lesions

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