Temporal trends in the use of drug-eluting stents for approved and off-label indications: a longitudinal analysis of a large multicenter percutaneous coronary intervention registry.
BACKGROUND
We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC).


OBJECTIVE
To determine whether the decrease in use of DES has affected both on and off-label indications.


METHODS
The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as ST-segment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions, were evaluated.


RESULTS
The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISR was less affected, though it also fell 25% (from 79%-56%).


CONCLUSIONS
The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies.
Gualano
Sarah K
SK
Department of Internal Medicine, Division of Cardiovascular Medicine, The University of Michigan, Ann Arbor, Michigan, USA.
Gurm
Hitinder S
HS
Share
David
D
Smith
Dean
D
Aronow
Herbert D
HD
LaLonde
Thomas
T
Bates
Eric R
ER
Changezi
Hameem
H
McNamara
Richard
R
Moscucci
Mauro
M
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000706:statistics & numerical data / Q000639:trends*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data / Q000639:trends*; D005260:Female; D019983:Guideline Adherence; D006331:Heart Diseases / Q000628:therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008670:Metals; D056687:Off-Label Use; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000639:trends*; D011356:Product Labeling / Q000639:trends*; D011474:Prosthesis Design; D012042:Registries; D015607:Stents / Q000706:statistics & numerical data / Q000639:trends*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D008670:Metals