Coronary Drug-Eluting Stents Deemed Safe

The U.S. Food and Drug Administration (FDA, Rockville MD, USA) has released a statement in which it states that coronary drug-eluting stents are safe and effective when used for FDA-approved indications.

The statement was released in response to inquiries asking for the agency's position on adverse events related to coronary drug-eluting stents (DES). The inquiries were made following the publication of recent data suggesting a small but significant increase in the rate of death and myocardial infarction (MI), possibly due to stent thrombosis in patients treated with DES. The increase in the rate of death and myocardial infarction observed in these studies was noted in patients followed 18 months to three years after stent implantation.

Currently the recommended DESs are the Cypher sirolimus-eluting coronary stent, manufactured by Cordis (Miami Lakes, FL, USA), and the Taxus Express paclitaxel-eluting coronary stent system, a product of Boston Scientific (Natick, MA, USA).

The FDA has announced it will convene a public meeting of the Circulatory System Devices advisory panel by the end of 2006 in an effort to improve knowledge regarding the incidence and timing of stent thrombosis as well as the appropriate duration of clopidogrel use in patients who receive DES. Although the duration of clopidogrel appeared to be adequate for the selected patients in the original clinical trials conducted to support FDA approval, the optimal duration of clopidogrel in more complex patients has not been defined.



Related Links:
U.S. Food and Drug Administration
Cordis
Boston Scientific