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.
Curtis
Jeptha P
JP
Yale University, New Haven, Connecticut, USA.
Cohen
David J
DJ
Jones
Philip G
PG
Bach
Richard G
RG
Spertus
John A
JA
Krumholz
Harlan M
HM
D000368:Aged; D030881:Disclosure; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration
D007166:Immunosuppressive Agents; D020123:Sirolimus