The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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Five-year clinical outcomes of drug-eluting stents according to on-label and off-label use

  • Park, Kyu-Hwan (Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center) ;
  • Kim, Ung (Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center) ;
  • Lee, Chan-Hee (Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center) ;
  • Son, Jang-Won (Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center) ;
  • Park, Jong-Seon (Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center) ;
  • Shin, Dong-Gu (Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center) ;
  • Kim, Young-Jo (Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center) ;
  • Cho, Jeong-Hwan (Division of Cardiology, Department of Internal Medicine, Daegu Veterans Hospital)
  • Received : 2015.02.23
  • Accepted : 2015.06.10
  • Published : 2016.07.01
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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.

Keywords

Acknowledgement

Supported by : Yeungnam University

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