Impact of the Food and Drug Administration’s Public Health Notification on the Adoption of Drug-Eluting Stents

We used data from 1,344 patients enrolled in the Prospective Registry Evaluating Myocardial Infarction: Events and Recovery study to examine the adoption of drug-eluting stents (DESs) and the effect of the release of the Food and Drug Administration’s preliminary public health notification, which raised concerns about DES safety. Overall, there was a dramatic increase in the use of DESs over the study period, from 32% in April 2003 to 81% in March 2004. The notification issued on October 29, 2003 was associated with a 26% relative decrease in DES use. By January 2004, DES use had returned to the prenotification rate and continued to increase thereafter. In conclusion, the Food and Drug Administration’s notification had a modest but temporary effect on clinical practice.