Cath Lab Digest - May 2008 - (Page 49)

49 Long-Term Financial Benefits of Drug-Eluting Stents: Report Available E ach year in the United States alone, almost 1 million people with coronary artery disease are treated with a percutaneous coronary procedure (PCI); worldwide the number is about 2.1 million. According to a new report by Kalorama Information, Major World Markets for Stents and the Economics of Drug-Eluting Technology, the current market for coronary stents in the seven major world healthcare markets is $4.9 billion. The market effects of drug-eluting stents (DES) began in 2003. Today they represent 69.2% of the total coronary stent market, expected to grow at a rate of about 4.6%. “Though drug-eluting stents cost 3 to 4 times as much as bare metal stents, when one examines their cost-effectiveness, the case is clear,” notes Kalorama analyst Kenneth Krul. “They remain an exciting innovation that will be a major part of cardiovascular intervention technologies over the next ten years, and it should become increasingly evident that DES use does in fact result in reduced long-term healthcare costs and improved economic outcomes.” The report can be purchased directly from Kalorama Information by visiting http://www.kaloramainformation.com/ Everolimus-Eluting Stent Shows Promise for Improving Outcomes in Patients With Coronary Artery Disease F or patients who underwent angioplasty, the use of stents releasing the drug everolimus reduced the rate of restenosis and significantly reduced the risk of major cardiac events, compared to paclitaxel-releasing stents, according to a study in the April 23/30 issue of JAMA. Gregg W. Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, and colleagues conducted the SPIRIT III trial to evaluate the everolimus-releasing stent in comparison to the paclitaxel-releasing stent in 1,002 patients with coronary artery disease. Patients were randomized 2:1 to receive the everolimus-releasing stent (n = 669) or the paclitaxel-releasing stent (n = 333). Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months. The researchers found that angiographic in-segment late loss was significantly less in the everolimus-releasing stent group compared with the paclitaxel group. At 9 months, everolimus stents, compared with paclitaxel stents, were noninferior for the outcome of target vessel failure (47 of 657 patients [7.2 percent] vs. 29 of 321 [9.0 percent], respectively. Use of the everolimus stent compared with the paclitaxel stent resulted in a 44-percent reduction (4.6 percent vs. 8.1 percent) at 9 months in the composite of major adverse cardiac events (cardiac death, heart attack, or target vessel revascularization), and a 42 percent reduction in the composite of major adverse cardiac events at 1 year (6.0 percent vs. 10.3 percent). This was due to fewer heart attacks and target lesion revascularization procedures. “This large-scale, prospective, randomized, single-blind, controlled study demonstrates that an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent results in a significant reduction in angiographic in-segment late loss at 8 months, with noninferior 9-month rates of ischemia-driven target vessel failure,” the authors write. In an accompanying editorial, Manesh R. Patel, MD, of Duke University, Durham, NC, and David R. Holmes, Jr., MD, of Mayo Clinic, Rochester, Minn., write that the results of the SPIRIT III trial are promising. “These data are encouraging and would qualify as demonstrating biological plausibility and mechanistic effect at the level of a phase 2 study,” they write. “What happens next with the everolimus-eluting stent is critical. The current data from the SPIRIT III trial are analogous to the initial comparisons of drug-eluting vs. bare-metal stents. Restenosis is reduced with the everolimus stent, potentially with a clinical reduction in target lesion revascularization and myocardial infarction. The clinical effect in a broad population of patients who may be clinically exposed following device approval is unknown. Furthermore, clinical efficacy without any mandated angiographic analysis and long-term safety remain important unanswered clinical issues. Postmarketing approval registries, although complex and expensive to perform optimally, may not address both these concerns.” “Physicians must continue to be judicious stewards of the interventional toolbox so that patients continue to allow them the privilege of performing procedures intended to improve their health.” ■ Heart Researchers Report Modest Progress in Including More Women in Studies A review of three and one-half decades of clinical cardiology trials shows that while an increasing number of women are being included in clinical trials, their numbers are still so low in some areas of research that it’s questionable whether study conclusions can be legitimately applied to women. The researchers, led by Dr. Chiara Melloni, a research cardiologist at the Duke Clinical Research Institute, examined the numbers of women included in 156 randomized clinical trials cited by the 2007 American Heart Association Guidelines for Cardiovascular Disease Prevention in Women. They found that overall, women comprised 30.6 percent of the total number of participants enrolled, with the number growing significantly during the past 36 years. In 1970, women comprised only 9 percent of those registered in the prevention trials. In 2006, that figure rose to 42.4 percent, although researchers say the latter figure reflects a striking increase in the number of single-sex trials. The researchers found that location of the trials appeared to play a role in participation: More women were enrolled in clinical trials in the U.S. (45 percent) compared to those abroad (26 percent). Clinical conditions appeared to make a difference, too, with the highest number of women found in trials for hypertension (41 percent), diabetes (39 percent), and stroke (37 percent), and lowest for trials related to heart failure (29 percent), coronary artery disease (24 percent), and high cholesterol (17 percent). The funding source for the studies did not seem to have any influence on the numbers of women involved. Women comprised about 30 percent of all participants enrolled in both government and privately-funded trials. “It’s heartening to note some gain in the numbers of women taking part in cardiovascular disease prevention trials, but we are still seeing substantial deficits in female representation in many areas of research,” says Dr. Kristin Newby, a cardiologist at Duke and senior author of the study. “The results of this study tell us that efforts to change that picture are not robust enough to make a difference and that we still have a lot of work to do to ensure that we can generate evidencebased, sex-specific treatment recommendations when they are appropriate.” ■ http://www.kaloramainformation.com/

Table of Contents Feed for the Digital Edition of Cath Lab Digest - May 2008

Cath Lab Digest - May 2008 The King Faisal Specialist Hospital and Research Centre Cell Therapy in the Cath Lab for Heart Failure: A Look at MyoCell® Therapy and the SEISMIC Trial Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Contents Clinical Editor’s Corner Commentary: Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Ask the STEMI Expert Comparing Drug-Eluting Stents and Bare-Metal Stents SICP: The Ten-Minute Interview with… Christopher Kambak, RT(R) Cardiac Cath Lab Economics in a Public Hospital of a Developing Country Keeping Your Heart & Vascular Employees: Proven Ideas for an Effective Retention Plan Unspoken Words Ask the Clinical Instructor Society of Invasive Cardiovascular Professionals Meetings Calendar Education Center What Do You Think? Clinical & Industry News Classifieds Advertisers Index

Cath Lab Digest - May 2008

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.