Association between off-label use of drug-eluting stents and subsequent stent thrombosis: a case-control analysis.
OBJECTIVE
We sought to examine the association between off-label drug-eluting stent (DES) use and stent thrombosis (ST) in unselected patients undergoing percutaneous coronary intervention (PCI).


BACKGROUND
DES are frequently used in clinical and angiographic scenarios not initially tested and approved by the FDA (off-label use) resulting in lingering concerns about the higher risk of ST in these situations.


METHODS
Out of 5,383 patients undergoing PCI at a single center between 2004 and 2006, 380 had death or myocardial infarction within 1 year. After adjudication using Academic Research Consortium definitions, patients with possible, probable or definite ST were termed cases. Cases were matched with controls, free of ST at 1 year, using geographic and temporal similarities. Off-label usage was defined using manufacturer's instructions and other standard criteria.


RESULTS
Overall, the proportion of off-label usage was higher among cases than controls (58% vs. 43%; p = 0.002) and both cases with definite/probable ST (77% vs. 59%; p = 0.08) and possible ST (54% vs. 37%; p = 0.002) had a higher off-label use than respective controls. Off-label use among cases with ST remained higher within the following subgroups: off-label by manufacturer's criteria (36% vs. 27%; p = 0.05), left main stent implantation (2% vs. 0%; p = 0.01), ostial (12% vs. 6%; p = 0.04) and bifurcated lesions (26% vs. 9%; p < 0.001). In multivariate analysis, being a case independently predicted off-label use (OR 1.68, 95% CI: 1.10-2.57; p = 0.02).


CONCLUSIONS
In this case-control analysis, off-label use of DES was independently associated with ST within 1 year, although the increased risk was moderate.
Rabinovitz
Asaf
A
Department of Medicine, Jacobi Medical Center, Bronx, New York, USA.
Bier
Dara M
DM
Wagman
Gabriel M
GM
Charlap
Esti
E
Nazari
Reza
R
Ghitelman
Jaime
J
Celaj
Sulejman
S
Skeif
Basel
B
Menegus
Mark
M
Srinivas
V S
VS
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D016022:Case-Control Studies; D003324:Coronary Artery Disease / Q000628:therapy*; D003328:Coronary Thrombosis / Q000150:complications / Q000453:epidemiology*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D056687:Off-Label Use; D012189:Retrospective Studies; D012307:Risk Factors; D012923:Social Class; D015607:Stents
D008670:Metals