Cath Lab Digest - November 2007 - (Page 53)

53 Adoption of Drug-Eluting Stents Associated with Lower Health Care Costs and Improved Clinical Outcomes Per Patient Cost Decreased by $1,900 T he 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 at the annual Transcatheter Cardiovascular Therapeutics 2007. David J. Cohen, MD, MSc, Director of Cardiovascular Research, Saint-Luke’s Mid-America Heart Institute, Kansas City, MO, and senior author of this study, said, “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 retreatment 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 feefor-service Medicare beneficiaries. Two years were chosen to represent the preDES (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 timeframe, there were significant improvements in most clinical outcomes for coronary revascularization patients, including reductions in rates of risk-adjusted mor- tality by 12 percent and 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. Cordis Corporation funded this study and assisted in the analysis of the data. ■ Endeavor Clinical Program Continues to Provide Positive Safety and Efficacy Data 12-Month ENDEAVOR IV Data Delivers Further Safety and Efficacy Evidence for Next-Generation Drug-Eluting Stent M edtronic, Inc. presented new 12-month data from the ENDEAVOR IV (E-IV) trial during a main-arena plenary session at TCT 2007 (Transcatheter Cardiovascular Therapeutics), sponsored by the Cardiovascular Research Foundation. “Significantly, the results at nine months, which contributed to the recent expert panel recommendation on October 10th for FDA approval of the Endeavor stent, were seen again at 12 months,” said Martin B. Leon, MD, Founder and Chairman Emeritus of the Cardiovascular Research Foundation, Professor of Medicine, Columbia University Medical Center (NY), and principal investigator of the ENDEAVOR III and ENDEAVOR IV trials. “ENDEAVOR IV reached its primary endpoint of TVF (target vessel failure) non-inferiority to the Taxus stent. It was very gratifying to learn that the Endeavor had similar efficacy compared to Taxus for all lesion subsets.” No statistically significant difference in TLR or TVR versus Taxus at 12 months was observed. Endeavor also demonstrated superior procedural success, as measured by the trial protocol. Furthermore, no cases of stent thrombosis were reported after six months in the E-IV trial. Also reported at TCT was a 12-month, interim analysis of the first 1,989 patients enrolled in ENDEAVOR Five (E-Five), a prospective international registry providing a real-world performance and safety evaluation of the Endeavor stent in markets where it is already commercially available. The primary endpoint of E-Five is MACE (a composite of Major Adverse Cardiac Events) at 12 months. The interim results of E-Five on nearly 2,000 patients demonstrate further consistency with the preceding clinical trial program. A low rate of MACE (7.0%) was observed, as was a low rate of target lesion revascularization (TLR) of 3.8%. The complete 12-month results on all 8,260 patients will be presented at EuroPCR in May. Importantly in E-Five, this consistency in performance and safety has also been observed in more complex patients. For E-Five, 34% of the patients had diabetes and 62% had complex lesions. Despite this complexity, the safety profile previously observed is reinforced by these data. Cardiac death was observed at only 2.0%, myocardial infarction at 1.3% and stent thrombosis of only 1.1%. Scott Ward, president of the CardioVascular business at Medtronic, said, “Following the panel’s recommendation, we are confident of approval before the end of this calendar year.” ■

Table of Contents Feed for the Digital Edition of Cath Lab Digest - November 2007

Henry Ford Heart and Vascular Institute Treating Patients with Complex Vascular Disease with a Multi-Disciplinary Approach Improving Patient Compliance with Antiplatelet Medications Clinical Editor’s Corner Cath Lab Nurse/Tech Vascular Access and Closure Using the StarClose® Device The Clinical and Economic Impact of Measuring Fractional Flow Reserve FFR and Choosing an Optimal Revascularization Strategy Finally! The New Registered Cardiac Electrophysiology Specialist (RCES) Credential Use of a Mobile Lab to ‘Test the Waters’ at a Rural Hospital Remembering a Cardiac Cath Lab History ACVP• Membership Page What Do You Think? The Ten-Minute Interview with… Ernie Livingston, RN, BSN SICP* Chapter Updates Who’s in Charge? Working to Eliminate Bottlenecks: Florida Hospital’s Cardiac Cath Lab Achieves Greater Efficiency and Higher Satisfaction Preserving Left Ventricular Function during Percutaneous Coronary Intervention Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Making the Most of Your First Impression: Interviewing Tips and Techniques CEU Education Center Clinical & Industry News Meetings Calendar

Cath Lab Digest - November 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.