Korean J Intern Med.  2016 Jul;31(4):678-684. 10.3904/kjim.2015.045.

Five-year clinical outcomes of drug-eluting stents according to on-label and off-label use

• Park KH
• Kim U
• Lee CH
• Son JW
• Park JS
• Shin DG
• Kim YJ
• Cho JH

• KMID: 2327743
• DOI: http://doi.org/10.3904/kjim.2015.045

Abstract

BACKGROUND/AIMS
To compare the clinical outcomes of 'on-label' and 'off-label' drug-eluting stents (DESs) over a 5-year follow-up period.
METHODS
A total of 929 patients that underwent percutaneous coronary intervention with DESs were enrolled. Patients were divided into two groups according to on-label (n = 449) and off-label (n = 480) indications. Off-label use was defined as implantation of DESs for acute myocardial infarction (MI), very small vessel, a long stenotic lesion, chronic total occlusion, a bifurcation lesion, an ostial lesion, left main coronary artery disease, multivessel disease, a saphenous vein graft lesion, and a lesion with thrombus. Endpoints were composite of major adverse cardiac events (MACEs), which included all-cause death, ischemic-driven target vessel revascularization (Id-TVR), MI, and stent thrombosis (ST). Clinical outcomes in the two groups were compared for up to 5 years postimplantation.
RESULTS
At 1 year postimplantation, the off-label group had higher incidences of total MACEs (8.2% vs. 3.7%, p = 0.005), Id-TVR (5.0% vs. 1.6%, p = 0.004), and ST (1.7% vs. 0.3%, p = 0.042), and at 5 years postimplantation, the off-label group continued to have higher incidences of total MACEs (17.5% vs. 9.4%, p < 0.001), Id-TVR (13.1% vs. 5.8%, p = 0.024), and ST (2.1% vs. 0.3%, p = 0.021). Multivessel disease and diabetes were found to be independent risk factors of MACE in patients with an off-label indication.
CONCLUSIONS
Patients treated with an on-label DES had better long-term clinical outcomes than those treated with an off-label DES.

Keyword

Off-label use; Drug-eluting stent; Outcome assessment (health care)

MeSH Terms

Coronary Artery Disease
Drug-Eluting Stents*
Follow-Up Studies
Humans
Incidence
Myocardial Infarction
Off-Label Use*
Outcome Assessment (Health Care)
Percutaneous Coronary Intervention
Risk Factors
Saphenous Vein
Stents
Thrombosis
Transplants