Keimyung Med J.  2018 Dec;37(2):49-60. 10.0000/kmj.2018.37.2.49.

Two-year Clinical Outcomes Following Everolimus-eluting Stent Use for Off-label Versus On-label Indications: From the Korean Multicenter Drug-eluting Stent Registry

Affiliations
  • 1Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea. k5112@dsmc.or.kr
  • 2Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea.
  • 3Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
  • 4Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
  • 5Department of Internal Medicine, Andong Medical Group Hospital, Andong, Korea.
  • 6Department of Internal Medicine, Sunlin Hospital, Pohang, Korea.
  • 7Department of Internal Medicine, Ulsan University Hospital, Ulsan, Korea.
  • 8rtment of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.

Abstract

BACKGROUND
Everolimus-eluting stent (EES) implantations have a relatively low rate of major adverse cardiac event (MACE) and target lesion revascularization (TLR) in patients with off-label use. However, the clinical outcome in the Korean population regarding EES in patients with off-label use is not well known. OBJECTS: The aim of the current analysis was to compare the clinical outcomes of on-label and off-label EES use over a 2-year follow-up period.
METHODS
Using patient-level data from a stent-specific, prospective, all-comer registry, we evaluated 987 patients (1,342 lesions) who received an EES (XIENCE V®, Abbott Vascular, Santa Clara, CA, USA) implantation between February 2009 and April 2011. The primary outcome was assessed: 2-year MACE (a composite endpoint of death from any cause, spontaneous myocardial infarction (MI), and any repeat revascularization). The clinical outcomes in the on- and off-label groups were compared at 2 years.
RESULTS
The majority of patients (79.0%) were treated for ≥1 off-label indication. The median duration of the clinical follow-up in the overall population was 2.0 years (interquartile range 1.9-2.1). At 2-years after the EES implantation in the enrolled patients, MACE occurred in 71 (7.9%) patients, cardiac death in 12 (1.3%), MI in 4 (0.5%), target vessel revascularization (TVR) in 33 (3.8%), TLR in 22 (2.5%), and definite or probable stent thrombosis (ST) in 1 (0.1%). Off-label EES implantations tend to increase the risk of 2-year MACE (4.7% vs. 8.8%, p = 0.063) without statistical significance. However, the rates of TLR were higher in the off-label EES implantations (0.0% vs. 3.2%, p = 0.013). In the multivariable analysis, renal failure, previous bypass surgery, previous cerebrovascular accident, and left main lesions were associated with 2-year MACE in patients with EES implantations.
CONCLUSIONS
The incidence of 2-year MACE was 7.9%, which that might be acceptable in all-comer patients treated with EES implantations. Although the off-label use of EES was not statistically associated with an increased risk of MACE, the TLR rate was higher in the off-label group, suggesting that physicians need to pay attention to high risk patients with the use of EES implantations.

Keyword

Coronary artery disease; Drug-eluting stents; Off-label use
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