Drug-Coated Stents Beneficial to Heart Patients (12/15/2007)

A study by Heart Center cardiologists at Wake Forest University Baptist Medical Center indicates that drug-coated stents are more beneficial than harmful in keeping the arteries of chest pain patients clear of blood clots.

The Heart Center at Wake Forest Baptist, was one of the first centers in North Carolina to participate in multicenter clinical trials of drug-coated stents versus bare-metal stents, and has participated in nine such clinical trials since 2001. In addition to participation in clinical trials, Heart Center cardiologists have evaluated outcomes in patients receiving stent therapy at Wake Forest Baptist.

Drug-coated stent use has been under fire as reports of blood clots associated with the devices have been documented. Because of these concerns of adverse late events with drug-coated stent use, the Food and Drug Administration recently convened a panel to review available data from both pivotal randomized clinical trial of drug-coated versus bare metal stent and post-randomized clinical trial registry and single-center studies.

Based on review of these data, the panel concluded that adverse late events occurred at a sufficient incidence to caution against use of drug-coated stents for treatment of conditions other than chest pain. However, data is lacking.

"Given our strong interest and experience in drug-coated stents, and in response to the FDA panel's concern about the safety of drug-coated stents, we evaluated the outcomes of stent therapy at our medical center," said Robert J. Applegate, M.D., professor of cardiology, lead investigator of the study at Wake Forest Baptist. "Our study of outcomes of stent therapy at nine months has been published in the American Journal of Cardiology."

"Briefly, we compared nine month outcomes in 1,164 consecutive bare metal stent patients in the year prior to introduction of drug-coated stents, and 1,285 consecutive comparable drug-coated stent patients."

"Our the team's observations of lower cumulative rates of non-fatal heart attacks and death at 9 months in drug-coated stent-treated patients compared to bare-metal stent-treated patients was reassuring that use of drug-coated stents in routine practice is safe," he said. "Longer-term follow-up safety and effectiveness studies of drug-coated stents use are being evaluated to determine if late drug-coated stent-related events will affect the balance of safety and effectiveness more than 2 years after drug-coated stent therapy."

Applegate's research team included: Matthew T. Sacrinty, M.P.H., biostatistician II, Michael A. Kutcher, M.D., professor of cardiology, Talal T. Baki, M.D., assistant professor of cardiology, Sanjay K. Gandhi, M.D., assistant professor of cardiology, Renato M. Santos, M.D., assistant professor of cardiology and William C. Little professor of cardiology, section head.

Note: This story has been adapted from a news release issued by the Wake Forest University Baptist Medical Center

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