Document Detail

Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study.
MedLine Citation:
PMID:  20031654     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The US Food and Drug Administration recently concluded that data on off-label drug-eluting stent (DES) safety are limited. However, in actual clinical practice, DES are often used for off-label indications, and observational studies demonstrate that complications are higher when compared with on-label use. We aimed to determine whether clinical outcomes differ after DES and bare-metal stent implantation in a patient cohort defined by DES off-label indications. METHODS AND RESULTS: We used the national revascularization registry in Scotland to identify patients who underwent coronary stenting for an off-label indication between January 2003 and September 2005. Individual-level linkage to comprehensive national admission and death databases was used to ascertain the end points of death, myocardial infarction, and target-vessel revascularization. We calculated propensity scores on the basis of clinical, demographic, and angiographic variables and matched DES to bare-metal stents on a 1:1 basis. The final study population consisted of 1642 patients, well matched for important covariables at baseline. Event-free survival was calculated over 24 months with the Kaplan-Meier method. All-cause death was more common after bare-metal stent implantation during follow-up (7.7% versus 6.6%; hazard ratio 0.63; 95% confidence interval, 0.40 to 0.99; P=0.04). No difference in the rates of myocardial infarction were noted (7.3% versus 7.5%; hazard ratio 1.02; 95% confidence interval, 0.69 to 1.54; P=0.92). Target-vessel revascularization was reduced in patients treated with DES (13.9% versus 10.7%; hazard ratio 0.67; 95% confidence interval, 0.49 to 0.93; P=0.02). CONCLUSIONS: At 24 months, patients treated with DES for off-label indications had lower rates of death and target-vessel revascularization and similar rates of myocardial infarction, as compared with patients treated with bare-metal stents.
David Austin; Keith G Oldroyd; Alex McConnachie; Rachel Slack; Hany Eteiba; Andrew D Flapan; Kevin P Jennings; Robin J Northcote; Alastair C H Pell; Ian R Starkey; Jill P Pell
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Circulation. Cardiovascular interventions     Volume:  1     ISSN:  1941-7632     ISO Abbreviation:  Circ Cardiovasc Interv     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2009-12-24     Completed Date:  2010-06-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101499602     Medline TA:  Circ Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  45-52     Citation Subset:  IM    
University of Glasgow, UK.
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MeSH Terms
Blood Vessel Prosthesis Implantation / adverse effects*,  mortality
Cohort Studies
Coronary Occlusion / therapy*
Drug-Eluting Stents / adverse effects*,  statistics & numerical data
Middle Aged
Myocardial Infarction / etiology*,  mortality
Off-Label Use / statistics & numerical data
Propensity Score
Survival Analysis
Treatment Outcome
Reg. No./Substance:

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