Document Detail

Impact of "off-label" utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention.
MedLine Citation:
PMID:  18237587     Owner:  NLM     Status:  MEDLINE    
The utilization of drug-eluting stents (DES) in "real world" practice has deviated from Food and Drug Administration-approved indications. Safety concerns have arisen from recent reports that suggested increased mortality and nonfatal myocardial infarction (MI) with DES usage. Little is known about the clinical outcomes of patients undergoing intracoronary DES implantation for unapproved indications as a group compared with outcomes after bare metal stent (BMS) placement. The clinical outcomes of 546 patients undergoing DES implantation for >or=1 non-Food and Drug Administration-approved ("off label") indication since the approval of the device were assessed. The group was then matched by propensity score with 546 patients receiving BMSs prior to DES approval for the same indications. The primary endpoint was major adverse cardiac events (cardiac death, nonfatal Q-wave myocardial infarction [MI], and target vessel revascularization) at 12 months. Baseline clinical and angiographic characteristics were well matched between BMS and DES groups. The use of debulking devices was higher in the BMS group. Patients in the BMS group were more likely to be treated with larger diameter and shorter stents. There was no significant difference in the rate of in-hospital and 30-day adverse cardiac events. At 12 months, the primary endpoint of major adverse cardiac events was significantly reduced in the DES group (23.6% vs 16.7%, p=0.004), driven by reductions in the need for repeat revascularization (target lesion revascularization: 16.4% vs 7.8%, p<0.001; target vessel revascularization: 20.2% vs 13.1%, p=0.003). There was no significant difference in freedom from cardiac death or nonfatal Q-wave MI between groups (p=0.27). In conclusion, the utilization of DES for non-Food and Drug Administration-approved indications proved to be efficacious and safe when compared with a BMS cohort matched by propensity score. The advantage for DES was driven by reductions in repeat revascularization. "Off-label" DES use was not associated with increased rates of cardiac death and nonfatal MI at 12 months.
Probal Roy; Ashesh N Buch; Aamir Javaid; Teruo Okabe; Vikram Raya; Tina L Pinto Slottow; Daniel H Steinberg; Kimberly Smith; Zhenyi Xue; Natalie Gevorkian; Lowell F Satler; Kenneth M Kent; William O Suddath; Augusto D Pichard; Joseph Lindsay; Ron Waksman
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2007-12-21
Journal Detail:
Title:  The American journal of cardiology     Volume:  101     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2008 Feb 
Date Detail:
Created Date:  2008-02-01     Completed Date:  2008-03-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  293-9     Citation Subset:  AIM; IM    
Division of Cardiology, Washington Hospital Center, Washington, DC, USA.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary*
Coronary Restenosis / epidemiology,  prevention & control
Drug Labeling
Drug-Eluting Stents / standards,  utilization*
Middle Aged
Myocardial Infarction / epidemiology,  prevention & control
Prosthesis Design
Retrospective Studies
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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