Practice Changes After an FDA Caution on Drug-Eluting Stents

Clinical practice change in response to a 2003 FDA notification about DES was modest and transient.

The FDA has devised a preliminary notification system whereby it alerts healthcare providers to public health issues when available information is limited but of concern. One such communication was made on October 29, 2003, regarding subacute thrombosis and hypersensitivity reactions to drug-eluting stents. In this alert, the FDA urged clinicians to adhere to manufacturers’ instructions for DES use. To determine the effect of this notification on actual DES use, investigators examined data from 1344 MI patients who enrolled in the multicenter Prospective Registry Evaluating Myocardial Infarctions: Events and Recovery (PREMIER) study after the introduction of DES in April 2003 and before April 2004.

Overall, 621 (46.2%) of the participants in…

Reviewing Author

Joel M. Gore, MD