WATERLOO, Belgium, March 17, 2010 /PRNewswire/ --
- SORT OUT III Data Presented at American College of Cardiology Meeting in Atlanta and Published in the Lancet
Investigators reported the long-term follow-up of the largest randomized comparison between the CYPHER(R) Sirolimus-eluting Coronary Stent and Medtronic's Endeavor(R) Stent highlighting significant and sustained clinical differences. These important findings were presented at the American College of Cardiology annual meeting, (ACC 2010) in Atlanta and published on-line in the prestigious journal The Lancet. The CYPHER(R) Stent was associated with significantly lower rates of death, myocardial infarction (heart attack), and repeat revascularization (the need for another procedure) than the Endeavor(R) Stent out to 18 months. This study adds to the unmatched body of safety and efficacy data on the CYPHER(R) Stent with this comparison to the more recently approved Endeavor(R) Stent in a contemporary setting.
The large randomized trial SORT OUT III included more than 2,300 patients across a wide range of lesion and patient complexity. The investigators reported that the mortality rate (4.4% for Endeavor(R) vs. 2.7% for CYPHER(R): p<0.035), incidence of heart attacks (2.1% for Endeavor(R) vs. 0.9 % for CYPHER(R): p<0.029), and composite endpoint of MACE (9.7 % for Endeavor(R) vs. 4.5 % for CYPHER(R): p<0.0001) was significantly lower in patients receiving CYPHER(R) compared to those receiving Endeavor(R). The incidence of "definite" late stent thrombosis was higher for Endeavor(R) than for CYPHER(R), but this difference was not statistically significant (1.1% for Endeavor(R) vs. 0.5% for CYPHER(R): p<0.13). Coupled with the safety advantage observed with CYPHER(R), there was an efficacy advantage as well: CYPHER(R) had significantly less frequent ischemia-driven target lesion revascularization through 18 months compared to Endeavor(R) (1.7% for CYPHER(R) vs. 6.1% Endeavor(R): p<0.0001).
"The SORT OUT III data highlight the excellent long-term safety and efficacy data of the CYPHER(R) Stent in a broad range of patients, and further show that there are important safety and efficacy differences between drug-eluting stents, in this case 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. "The superior safety and efficacy of the CYPHER(R) Stent compared to the Endeavor(R) stent in this real-world randomized study reinforce the excellent sustained clinical outcomes consistently seen over the last 10 years. There now have been six different sets of data from randomized clinical trials and registries--Endeavor III, SORT OUT III, ZEST, ISAR TEST II, the SCAAR diabetes data and the Western Denmark Registry-in which the CYPHER(R) Stent outperformed the Endeavor(R) Stent in key outcome measures, including in long term follow-up," Dr. Rogers noted.
Dr. Jens Flensted Lassen, Principal Investigator of the SORT OUT III trial and associate professor at the Department of Cardiology, Aarhus University Hospital in Denmark pointed to the fact that two main characteristics of the SORT OUT III trial could have caused the difference: the SORT OUT trial was an all-comer trial that accepted nearly all patients receiving a drug-eluting stent, and it was powered to assess clinical endpoints. "If you want to assess clinically relevant differences between the various drug-eluting stents, you have to compare the stents in routine clinical care patients," Dr. Jens Flensted Lassen noted. "As an example the Endeavor III was performed in 436 low-risk patients with a single non-complex lesion and was only powered to assess an angiographic endpoint. SORT OUT III randomized 2,332 all-comers and was powered to assess a clinical endpoint." Another characteristic of the SORT-OUT III trial was the use of Danish health registries to detect clinical events during follow-up. "This means that only clinical events which were seriously enough to bring the patient in contact with the health care system were detected and thereby bringing the results more in line with what is seen in daily clinical practice . Furthermore, the results were unaffected by biases since there were no direct patient contact and no angiographic follow up during the study", Dr. Lassen stated.
"We continue to be gratified by the outstanding performance of CYPHER(R) compared with other drug-eluting stents. The breadth of clinical safety and efficacy data and the long-term follow-up data on patient outcomes associated with the CYPHER(R) Stent are unmatched by the competition, and this gap continues to widen," Dr. Rogers concluded.
About the CYPHER(R) Stent
The CYPHER(R) 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(R) Stent in a broad range of patients.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at http://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 http://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(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
**The third party trademarks used herein are trademarks of their respective owners.
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