RIDGEWATER, N.J.--(BUSINESS WIRE)--Investigators reported results of SORT-OUT IV, comparing Cordis Corporation’s CYPHER® Sirolimus-eluting Coronary Stent and Abbott’s XIENCE V ® Everolimus-eluting Stent in the primary endpoint of MACE (major acute coronary events) at nine months. These findings were presented at the TCT annual meeting, (TCT 2010)held last week in Washington DC. This study adds to the unmatched body of safety and efficacy data on the CYPHER® Stent with this comparison to the more recently approved XIENCE V® Stent in a contemporary setting.
“The SORT OUT consortium has used CYPHER® Stent as the comparator in a number of studies and to date, no newer stent has proven a benefit over CYPHER® Stent in terms of safety or efficacy,” said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation. “The safety and efficacy of the CYPHER® Stent in this real-world randomized study reinforce the excellent sustained clinical outcomes consistently seen over the last 10 years.”
The large randomized trial SORT OUT IV included more than 2,600 patients across a wide range of lesion and patient complexity. The study was designed to test whether the XIENCE V® stent is non-inferior to the CYPHER® stent. Both drug-eluting stents performed better than planned for the composite endpoint of MACE (4.9 % for XIENCE V® Stent vs. 5.2% for CYPHER® Stent); these data support the non-inferiority of the XIENCE stent over the CYPHER stent (non-inferiority p=0.01) . There was no statistically significant difference in key markers of safety including the incidence of cardiac death (1.9% for XIENCE V Stent vs. 1.4% for CYPHER Stent: p=0.31), myocardial infarction, (1.1% for XIENCE V Stent vs. 1.4% for CYPHER Stent: p=0.48), or definite or probable stent thrombosis (0.9% for XIENCE V Stent vs. 0.9% for CYPHER Stent: p=0.83).
“The SORT OUT IV trial demonstrates that both drug eluting stents perform extremely well,” said Rogers. “The unique design characteristics of the CYPHER® Stent continue to make it an essential treatment option for today’s interventional cardiologists.”
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.
