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Drug-coated stents effective in 'real world' patients

DALLAS, Dec. 23 Drug-coated stents are safe and effective at preventing death, heart attack or repeat procedures in "real world" patients who are often sicker or older than those selected for clinical trials, according to a study in today's rapid issue of Circulation: Journal of the American Heart Association.

The drug-coated stents were more effective than uncoated stents, just as they had been in clinical trials, said lead investigator Patrick W. Serruys, M.D., Ph.D., professor of cardiology at Erasmus Medical Center in Rotterdam, the Netherlands.

This "real world" research is important because patients in clinical trials of drug-coated stents "were a very select group, whereas this registry is an attempt to look at in an unselected population," Serruys said. "Sixty-eight percent of the patients in this study did not meet the selection criteria for the clinical trials."

Stents are tiny flexible wire mesh tubes that prop open blocked arteries in the heart. Drug-eluting stents are coated with slow-release drugs that help prevent cell re-growth that can re-narrow the artery.

These one-year results from the Rampamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry show that 9.7 percent of patients who received the drug-eluting stents had a major adverse cardiac event, compared with 14.8 percent of those treated with bare metal stents.

Only 3.7 percent of the patients treated with drug-eluting stents had a renarrowing of the treated vessel that required repeat procedures, while 10.9 percent of the patients in the bare-metal stent group required repeat interventions.

"The treatment effects particularly the reduction of reinterventions were similar across very different subgroups of patients," Serruys said. "The effect was the same in long lesions and short lesions, in small vessels, and in all kinds of anatomic settings."

The study included 508 patients with previously untreated blocked a
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Contact: Carole Bullock
carole.bullock@heart.org
214-706-1279
American Heart Association
22-Dec-2003


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