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SCAI president testifies before FDA on safety of drug-eluting stents

al cardiologist for more than 25 years and is a professor of medicine at the Texas A&M University College of Medicine and director of the Cardiology Division at the Scott & White Clinic.

Because data are limited, the precise rate of delayed blood clot formationknown as late stent thrombosisis unknown. Current information suggests it is small, however, representing 1 additional case of late stent thrombosis per every 200 to 500 patient-years in those treated with a drug-eluting stent, over what would be expected with a bare metal stent.

This must be weighed against the substantial benefits of drug-eluting stents, Dr. Dehmer said. Simply put, patients who avoid renarrowing of their coronary arteries as a result of drug-eluting stent placement avoid the need for repeat procedures, which themselves have small but definite risks.

Dr. Dehmer pointed out that it is common for challenges to arise after introduction of a new medical technology, and for its use to evolve over time. Bare metal stents, for example, reduced the risk of restenosis by half, as compared to conventional balloon angioplasty, and were greeted with widespread enthusiasm. But restenosis within a stent was very difficult to treat, prompting the introduction of internal radiation of the coronary arteries, a technique that had its own set of problems, including late stent thrombosis.

"It is difficult to think of any area in medical care where challenges and solutions did not occur during introduction of a new therapy into practice," Dr. Dehmer said. "We are now faced with a possible problem with drug-eluting stents late stent thrombosis. Like all of the problems that preceded it, this too will have a solution."

Finally, medical decision-making has always been guided by the balance between benefit and risk, Dr. Dehmer said. As an example, he pointed to the well-established benefits of aspirin for preventing heart attack and stroke in patients with heart
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Contact: Wayne Powell
wpowell@scai.org
703-772-7910
Society for Cardiovascular Angiography and Interventions
7-Dec-2006


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