Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group.
OBJECTIVE
This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications.


BACKGROUND
Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied.


METHODS
The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses.


RESULTS
Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months.


CONCLUSIONS
Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.
Brodie
Bruce R
BR
LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina, USA. bbrodie@triad.rr.com
Stuckey
Thomas
T
Downey
William
W
Humphrey
Angela
A
Bradshaw
Barbara
B
Metzger
Chris
C
Hermiller
James
J
Krainin
Fred
F
Juk
Stanley
S
Cheek
Barry
B
Duffy
Peter
P
Smith
Henry
H
Edmunds
John
J
Varanasi
Jay
J
Simonton
Charles A
CA
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000401:mortality; D003257:Consumer Product Safety; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D018579:Patient Selection; D011356:Product Labeling; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D008670:Metals