Healthcare Industry News: drug-eluting stent
News Release - October 23, 2007
Adoption of Drug-Eluting Stents Associated with Lower Health Care Costs and Improved Clinical OutcomesPer Patient Cost Decreased by $1,900 Following Introduction of Innovative Devices
WASHINGTON--(HSMN NewsFeed)--The introduction of drug-eluting stents (DES) was associated with reduced health care costs while providing improved clinical outcomes compared to the pre-DES era according to data presented here today at the annual Transcatheter Cardiovascular Therapeutics 2007.
“These results suggest that medical innovation, like the development and introduction of drug-eluting stents, can have value by contributing to improved clinical outcomes and reduced overall health care costs,” said David J. Cohen, M.D., M.Sc., Director of Cardiovascular Research, Saint-Luke’s Mid-America Heart Institute, Kansas City, Mo., and senior author of this study. The results were presented by Jason Ryan, M.D., M.P.H., Cardiology Fellow, Beth Israel Deaconess Medical Center in Boston, Mass.
“Despite higher up-front costs for DES procedures, aggregate spending for cardiovascular care decreased by more than $1,900 per patient needing revascularization. This reflects both the shift from bypass surgery to percutaneous coronary intervention (PCI) as initial treatment and downstream cost savings due to improved clinical outcomes such as reduced need for re-treatment among these patients.”
Data were analyzed from the Medicare Standard Analytic File (SAF), which contains all inpatient, hospital outpatient, skilled nursing, physician and supplier claims for 5 percent of fee-for-service Medicare beneficiaries. Two years were chosen to represent the pre-DES (2001) and post-DES (2004) eras. The CYPHER® Sirolimus-eluting Coronary Stent was approved for marketing by the U.S. Food and Drug Administration in 2003.
The primary objectives of the analysis were to examine the impact of the introduction of drug-eluting stents on overall coronary revascularization rates and treatment patterns among the Medicare population, to determine whether changes in revascularization patterns were associated with changes in clinical outcomes, and to determine the overall impact of these changes on total health care costs, as assessed from the perspective of the Medicare program.
Between 2001 and 2004, the introduction of DES was associated with substantial changes in both the practice and the outcomes of coronary revascularization among older Americans. Notably, there was a shift from bypass surgery (CABG) to PCI over this time period. In addition, the proportion of patients over the age of 79 increased from 2001 to 2004 and these patients were more likely at this time point to have co-morbidities including diabetes, heart failure and hypertension.
In 2004, the first full year of DES availability, 75 percent of PCI procedures used DES while the proportion of patients receiving bypass surgery decreased by 8 percent. Over this same time frame, there were significant improvements in most clinical outcomes for coronary revascularization patients, including reductions in rates of risk-adjusted mortality by 12 percent and heart attacks (myocardial infarction) by 29 percent. While the introduction of DES was not the only change to the system during these two periods, it was noted as the largest and most significant.
The analysis also showed that the introduction of DES was not associated with any evidence of an adverse safety signal. These findings are consistent with newly released data on the long-term safety of DES including the Swiss Meta analysis, which appeared in The Lancet, the Ontario DES registry from The New England Journal of Medicine, as well as data from the European Society of Cardiology meeting in Vienna, including the SCAAR registry, the Western Denmark registry and data from Bern/Rotterdam.
“Although other factors may have contributed to these results, these findings support both the clinical and economic value of drug-eluting stents in the treatment of older Americans requiring coronary revascularization,” said Liesl Cooper, PhD, Vice President, Health Economics and Reimbursement, Cordis Corporation. “In addition we are pleased to see that these data are consistent with other recent data in terms of the safety of drug-eluting stents.”
Cordis Corporation funded this study and assisted in the analysis of the data.
About the CYPHER® Stent
The CYPHER® Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than 3 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.
The CYPHER® 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 a sirolimus-eluting stent, the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT™ 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 www.cypherstent.com.
About Cordis Corporation
Cordis, 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.
(This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Cordis expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson s Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Cordis does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
- 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.
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