Impact of the Food and Drug Administration's Public Health Notification on the adoption of drug-eluting stents

Am J Cardiol. 2007 May 1;99(9):1227-9. doi: 10.1016/j.amjcard.2006.12.031. Epub 2007 Mar 16.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Disclosure*
  • Female
  • Guideline Adherence
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Myocardial Infarction / therapy
  • Practice Guidelines as Topic
  • Product Surveillance, Postmarketing*
  • Registries
  • Sirolimus / administration & dosage*
  • Stents / adverse effects
  • Stents / statistics & numerical data*
  • United States
  • United States Food and Drug Administration*

Substances

  • Immunosuppressive Agents
  • Sirolimus