Additional analysis of 18 month data provides detail on safety and efficacy outcomes in patients with diabetes, acute coronary syndrome, or treatment of multiple lesions
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- 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. 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® Stent and the Endeavor® 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® Sirolimus-eluting Coronary Stent over Medtronic’s Endeavor® 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 to 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® 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® 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® 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 that there are significant safety and efficacy differences between drug-eluting stents, in this case the CYPHER® Stent and the Endeavor® Stent,” said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation. “In these data sets, risks of adverse events are up to five-fold higher with the Endeavor® Stent than with the CYPHER® Stent, including in patients with other complications like diabetes.”
The CYPHER stent does not have an FDA-approved indication for use in patients with diabetes, acute coronary syndrome, or multi-vessel disease.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.
**The third party trademarks used herein are trademarks of their respective owners.
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