Clinical Data Reveals Bare-Metal Stents May Be More Effective Than Predicted; New Study Shows Less than 8 Percent of Patients Need Follow-up Procedures in Stented Arteries.

ATLANTA -- The benefits of switching from bare-metal stents to drug-eluting stents to reopen blocked coronary arteries may be smaller than previous trials indicated, according to a study published in the August issue of Clinical Cardiology. The findings, based on data provided by Goodroe Healthcare Solutions, are notable given ongoing discussions about the safety and effectiveness of drug-eluting stents.

The study comes amidst recent reports that drug-eluting stents may contribute to potentially deadly blood clots.

Stents are small, wire-mesh tubes placed in a heart artery following angioplasty, a procedure to reopen blocked or narrowed arteries. Some stents are made of bare metal, which requires repeat treatment known as revascularization. The newer (and more expensive) drug-eluting stents are coated with drugs designed to prevent repeat blockage of the artery.

For their study, the researchers - interventional cardiology expert Spencer B. King, III, M.D., FACC from the Fuqua Heart Center of Piedmont Hospital in Atlanta; Cynthia Yock from the Center for Primary Care and Outcomes Research at Stanford University's School of Medicine; and Mike Isbill of Goodroe Healthcare Solutions - reviewed clinical outcomes from 17,000 bare-metal stent patients and found that less than 8 percent of the patients needed additional blockage treatment after the first follow-up month. This is less than half the rate originally reported in drug-eluting stent trials.

Goodroe Healthcare Solutions, a firm that helps hospitals improve clinical quality and economic performance, looked at detailed clinical data from 17,000 people who received bare-metal stents from December 1998 through March 2003. This information was collected from 17 hospitals across the country that use Goodroe's CathSource(R) Enterprise software, which feeds information into the Goodroe Data Warehouse, the nation's largest warehouse of data on outcomes, costs and productivity measures for cardiac catheterization labs, as well as for cardiac and orthopedic surgery procedures.

"This study provides a real-life example of the importance of collecting and evaluating clinical data," said Joane Goodroe, founder of Goodroe Healthcare Solutions. "Now, we have information that questions the value of using expensive drug-eluting stents, rather than bare-metal stents, during cardiac catheterization procedures." The study, she noted, adds to a growing body of evidence that bare-metal stents are effective, and may in fact be more effective than earlier trials had suggested. "This effort demonstrates that hospitals must have access to better outcomes data to make smarter decisions about the resources they use to provide patient care," Goodroe added.

Physicians' rapid acceptance of drug-eluting stents in 2002 was based on evidence from manufacturer-sponsored clinical trials that showed they reduced the need for revascularization by as much as 81 percent compared with bare-metal stents. However, the Stanford study, along with meta-analysis done by Drs. Babapulle and Brophy (published in The Lancet), shows there is no significant difference in serious events, such as mortality and post-stent heart attack, between patients receiving drug-eluting stents and those receiving bare-metal stents.

"Our most recent study indicates that while drug-eluting stents may be the latest technology for coronary disease, they do not provide the degree of improvement in clinical results that was suggested by the trials," said Dr. King, who is a former president of the American College of Cardiology and a pioneer in the development of the angioplasty procedure.

Because coronary disease is progressive in nature, many patients require additional catheterization procedures to clear blockages in other areas. However, the Stanford study with King et al. found that in 19 out of 20 subgroups of the bare-metal stent patients, between 4 percent and 10 percent of the patients required repeat revascularization. With 90 percent of all stent patients now receiving drug-eluting stents to prevent further blockages, this study suggests that many of these patients would be equally well served by using less-expensive bare-metal stents.

About Goodroe Healthcare Solutions, LLC - Goodroe Healthcare Solutions is an Atlanta-based firm that concentrates on helping hospitals reduce costs and improve quality in specialty surgical areas quality. Goodroe's clinical consultants work with hospitals to analyze their care processes and find ways to make hospitals more efficient while improving effectiveness. Goodroe focuses on cardiology, orthopedic medicine and neurosurgical procedures, such as insertion of spinal implants. These important specialty services generate 60 to 80 percent of supply costs for many large hospitals, as well as considerable revenues, so controlling costs associated with these procedures can help hospitals improve their financial health and assure that resources are available to fund other patient care activities.