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

Jeptha P. Curtis; David J. Cohen; Philip G. Jones; Richard G. Bach; John A. Spertus; Harlan M. Krumholz

doi:10.1016/j.amjcard.2006.12.031

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

Jeptha P. Curtis, David J. Cohen, Philip G. Jones, Richard G. Bach, John A. Spertus, Harlan M. Krumholz

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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.

Original language	English
Pages (from-to)	1227-1229
Number of pages	3
Journal	American Journal of Cardiology
Volume	99
Issue number	9
DOIs	https://doi.org/10.1016/j.amjcard.2006.12.031
State	Published - May 1 2007

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title = "Impact of the Food and Drug Administration's Public Health Notification on the Adoption of Drug-Eluting Stents",

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.",

author = "Curtis, {Jeptha P.} and Cohen, {David J.} and Jones, {Philip G.} and Bach, {Richard G.} and Spertus, {John A.} and Krumholz, {Harlan M.}",

note = "Funding Information: This study was supported by CV Therapeutics, Palo Alto, California. ",

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AU - Curtis, Jeptha P.

AU - Cohen, David J.

AU - Jones, Philip G.

AU - Bach, Richard G.

AU - Spertus, John A.

AU - Krumholz, Harlan M.

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AB - 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.

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

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