Five-year clinical outcomes of drug-eluting stents according to on-label and off-label use.
- Author:
Kyu Hwan PARK
1
;
Ung KIM
;
Chan Hee LEE
;
Jang Won SON
;
Jong Seon PARK
;
Dong Gu SHIN
;
Young Jo KIM
;
Jeong Hwan CHO
Author Information
- Publication Type:Original Article
- Keywords: Off-label use; Drug-eluting stent; Outcome assessment (health care)
- MeSH: 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
- From:The Korean Journal of Internal Medicine 2016;31(4):678-684
- CountryRepublic of Korea
- Language:English
- 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.
