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

(December 7, 2006 WASHINGTON, DC) -- In testimony before the Food and Drug Administration (FDA), Gregory J. Dehmer, MD, president of the Society for Cardiovascular Angiography and Interventions (SCAI), today urged a review panel to evaluate new data on the safety of drug-eluting stents (DES) from the perspective of prior developments in the history of coronary intervention, and with an appreciation for the balance of benefits and risks that guides all clinical decision-making.

As president of SCAI, Dr. Dehmer spoke on behalf of the professional organization representing the vast majority of physicians who perform invasive cardiac procedures, including the placement of coronary artery stents. "SCAI has been and will continue to be at the forefront in providing guidance to physicians regarding the use of drug-eluting stents," said Dr. Dehmer, who cited the Societys proactive role in publishing clinical alert documents on drug-eluting stents and other therapies for patients with heart disease.

Drug-eluting stents were approved by the FDA in 2003. These devices, which prop open narrowed arteries in the heart, are coated with a medication that prevents the build-up of scar tissue inside the stent. Drug-eluting stents have proven so successful in preventing renarrowing of the artery or restenosis they were being used in 80 to 90 percent of stent procedures, thereby sparing patients the need for a repeat procedure to restore blood flow through a constricted artery.

A new concern has arisen, however. Several recent analyses that tracked patient outcomes for four to five years after stent placement showed that blood clots appear slightly more likely to form inside a drug-eluting stent than in a bare metal stent. When this occurs, the patient may suffer a heart attack or even die. "Clearly, this unexpected new observation is worrisome, but it must be evaluated in the proper context," said Dr. Dehmer, who has practiced as an intervention

Contact: Wayne Powell
Society for Cardiovascular Angiography and Interventions

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