Navigation Links
Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent
Date:9/4/2007

While no significant differences were found, results showed CYPHER(R) Stent

had lower mortality and heart attack rates

VIENNA, Austria, Sept. 4 /PRNewswire/ -- A subgroup analysis of diabetic patient data from a two-year randomized controlled trial comparing the CYPHER(R) Sirolimus-eluting Coronary Stent to the Taxus Stent showed no statistically significant differences in safety outcomes between the two drug- eluting stents. The authors of the analysis, presented today at the European Society of Cardiology Congress 2007 (ESC Congress 2007), also reported that in the CYPHER(R) Stent arm there were numerically lower rates of cardiac mortality, blood clots and heart attack rates than in the Taxus Stent arm, although these differences did not reach statistical significance.

"In this analysis of head-to-head randomized controlled trial data, both drug-eluting stents yielded similar safety outcomes and the CYPHER(R) Stent presented safety rates in some areas that were numerically lower," Giulio Guagliumi, M.D., from the Ospedale Riuniti Di Bergamo in Bergamo, Italy, who presented the results on behalf of the REALITY Trial investigators.

The cardiac death rates were 1.6 percent for the CYPHER(R) Stent and 4.7 percent for the Taxus Stent (p=0.14). The rate of Q-wave myocardial infarction (heart attacks that involve the full thickness of the heart wall) was 0.0 percent for the CYPHER(R) Stent and 1.6 percent for the Taxus Stent (p=0.25). In addition, the rates of non-Q wave myocardial infarctions (heart attacks that do not involve the full thickness of the heart wall) were 4.8 percent for the CYPHER(R) Stent and 5.2 percent for the Taxus Stent (p=1.00). None of these numerical differences in favor of the CYPHER(R) Stent reached statistical significance.

Both drug-eluting stents were also equivalent in terms of major adverse cardiac events (MACE), which in this study were defined to include cardiac deaths, Q-wave myocardial infarctions, non-Q wave myocardial infarctions, emergent bypass surgery and target lesion revascularizations (a subsequent procedure to reopen an artery). The MACE rate for the CYPHER(R) Stent was 15.5 percent while the MACE rate for the Taxus Stent was 14.1 percent (p=0.77).

At the World Congress of Cardiology 2006, the REALITY Trial investigators reported a stent thrombosis rate for the Taxus Stent that was significantly higher than the rate for the CYPHER(R) Stent in the overall patient population (2.5 percent for the Taxus Stent versus 0.9 percent for the CYPHER(R) Stent; p log-rank=0.02). While the difference between the protocol-defined stent thrombosis rate for each drug-eluting stent in the diabetic patient subgroup did not reach statistical significance, the rate for the Taxus Stent remained numerically higher than the rate for the CYPHER(R) Stent (3.1 percent for the Taxus Stent versus 1.1 percent for the CYPHER(R) Stent; p log-rank=0.16).

These numerically lower rates of cardiac death, Q-wave myocardial infarction and stent thrombosis favoring the CYPHER(R) Stent were also seen in diabetic patients who required insulin therapy.

"Diabetic patients remain one of the most complex patient populations to treat for coronary artery disease," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "This analysis provides additional and relevant information to doctors regarding the long- term efficacy and safety outcomes in diabetic patients treated with either the CYPHER(R) Stent or the Taxus Stent."

The analysis involved 375 diabetic patients, which represented 28 percent of the patients enrolled in the REALITY Trial. The REALITY Trial was comprised of 1,386 moderately complex patients from 90 centers in Europe, Latin America and Asia. These patients were randomly selected to receive either the CYPHER(R) Stent or the Taxus Stent. In the end, the CYPHER(R) Stent was used in 684 patients and 970 artery blockages, while the Taxus Stent was used in 669 patients and 941 artery blockages.

Cordis Corporation sponsored the REALITY Trial.

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.

Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER SELECT(TM) Sirolimus- eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT(TM) Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.

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.


'/>"/>
SOURCE Cordis Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Genzyme and Bayer HealthCare Announce Detailed Interim Two-Year Alemtuzumab in Multiple Sclerosis Data Presented at AAN
2. Two-year data for Angiotechs Vascular Wrap Paclitaxel-Eluting Mesh to be Presented at European Vascular Symposium
3. Two-Year Results from the Medtronic ENDEAVOR III Trial Confirm Stents Positive Clinical Profile
4. Two-Year Patient Registry Results Support Safety and Efficacy of Cypher Sirolimus-Eluting Coronary Stent in Real World Uses
5. Skin Rash Actually Signifies Better Outcomes for Pancreatic and Lung Cancer Patients
6. MEDIA ADVISORY: Subsets of Landmark Diabetes Trials Investigating MacroVascular Outcomes Presented at the American Diabetes Association 67th Scientific Sessions
7. New Study Suggests Better Patient Outcomes with CYPHER Sirolimus-Eluting Coronary Stent than with Taxus Stent in Real-World Clinical Settings
8. Taxus VI Clinical Trial Demonstrates Positive Long-Term Outcomes for Moderate-Release Paclitaxel-Eluting Stent at Four Years
9. Cypher Sirolimus-Eluting Coronary Stent Had Similar Results to Bypass Surgery and Better Outcomes Than Bare Metal Stents in Subgroup Analysis of Diabetic Patients With Multivessel Coronary Disease
10. Urinalysis Analyzers: Large Capabilities in Every Size Device
11. Large Geographic Differences in EpiPen Prescriptions in the U.S., From the Journal of Allergy and Clinical Immunology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/8/2017)... June 8, 2017   Responding to Heath Ledger,s ... the death of singer Chris Cornell in May, ... International offers a free online psychiatric drug ... and families about psychotropic drug risks. The ... died from an accidental overdose, has called for tighter rules ...
(Date:6/7/2017)... Md. , June 7, 2017  Novavax, Inc., (Nasdaq: ... second of two Phase 2 trials of its RSV F ... of child bearing age have been published in the journal ... publication have been shared in prior scientific conferences). The Company ... in April 2014. Novavax is developing the RSV F Vaccine ...
(Date:6/5/2017)... , June 5, 2017 Kohll,s Pharmacy & Homecare is ... the United States . The Raizer is a ... fallen person up to an almost-standing position within ... operated by one assistant and does not require ... enough that a child can operate it, and ...
Breaking Medicine Technology:
(Date:6/20/2017)... ... 20, 2017 , ... AMC Health , the leading provider of proven ... trials market. Similar to its approach in demonstrating positive outcomes in the healthcare market, ... proving the value of eVisits to support virtual studies. , In a ...
(Date:6/20/2017)... ... June 20, 2017 , ... With certifications and experience that puts ... NJ, Drs. Adam and Hal Kimowitz are currently accepting new patients at their practice ... can cause for some patients, which is why they offer the latest in modern ...
(Date:6/20/2017)... ... June 20, 2017 , ... Uniform Advantage (UA), a multi-channel retailer ... designed to create tailored looks and athleisure-inspired outfits. UA Flex fabric is breathable, wrinkle ... twill. , With trendy looks hitting the medical community, UA Flex is for the ...
(Date:6/20/2017)... ... 20, 2017 , ... MEDI+SIGN, a healthcare technology company that ... Stanowski, DHA, FACHE to the MEDI+SIGN Advisory Board. , “We are eager ... provide invaluable direction for the company,” says Andrew Hoffman, President of MEDI+SIGN. ...
(Date:6/19/2017)... ... June 19, 2017 , ... The joyful summer wedding ... to be a humdinger. A warm winter and wet spring have created ideal conditions ... one wants to be swatting away pesky mosquitoes when a bride and groom are ...
Breaking Medicine News(10 mins):