"Off-label" stent therapy 2-year comparison of drug-eluting versus bare-metal stents.
OBJECTIVE
The aim was to compare 2-year outcomes with the routine use of drug-eluting stents (DES) (>75% "off-label") with a comparable group treated with bare-metal stents (BMS).


BACKGROUND
Safety concerns >1 year from implantation have been raised about DES used "off-label." There are limited data comparing DES and BMS in "off-label" patients.


METHODS
Clinical outcomes (nonfatal myocardial infarction [MI], all-cause mortality) were assessed in 1,164 consecutive patients who received BMS in the year before introduction of DES at Wake Forest University Baptist Medical Center and 1,285 consecutive patients who received DES after it became our routine choice. "On-label" stent use was defined as treatment for a single de novo lesion <30 mm, without recent MI or other major illnesses.


RESULTS
At 2 years, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.77 (95% confidence interval [CI] 0.62 to 0.95), for all-cause mortality 0.71 (0.54 to 0.92), and stent thrombosis (ST) 0.97 (0.49 to 1.91). "On-label" stent procedures were associated with lower risk of MI, death, and ST than "off-label" stent procedures. For "off-label" stent procedures, the hazard ratio for DES compared with BMS for nonfatal MI or death was 0.78 (95% CI 0.62 to 0.98), all-cause mortality 0.72 (0.54 to 0.94), and ST 0.91 (0.46 to 1.80). The hazard of nonfatal MI or death was similar or lower for DES than BMS in high-risk subgroups, including renal failure and recent MI.


CONCLUSIONS
The routine clinical use of drug-eluting stents for "off-label" indications was associated with lower nonfatal MI and death at 2 years than in a comparable group of patients treated with BMS.
Applegate
Robert J
RJ
Section of Cardiology, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1045, USA. bapplega@wfubmc.edu
Sacrinty
Matthew T
MT
Kutcher
Michael A
MA
Santos
Renato M
RM
Gandhi
Sanjay K
SK
Baki
Talal T
TT
Little
William C
WC
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects; D019917:Blood Vessel Prosthesis Implantation; D023903:Coronary Restenosis / Q000517:prevention & control* / Q000601:surgery; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects; D006629:Hirudins / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects; D016016:Proportional Hazards Models; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D055502:Secondary Prevention; D020123:Sirolimus / Q000008:administration & dosage; D016896:Treatment Outcome
D000925:Anticoagulants; D006629:Hirudins; D007166:Immunosuppressive Agents; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; D017239:Paclitaxel; C074619:bivalirudin; D020123:Sirolimus