KMID : 0980720180370020049
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Keimyung Medical Journal 2018 Volume.37 No. 2 p.49 ~ p.60
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Two-year Clinical Outcomes Following Everolimus-eluting Stent Use for Off-label Versus On-label Indications: From the Korean Multicenter Drug-eluting Stent Registry
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Pae Jong-Yop
Lee Cheol-Hyun Choi Ji-Yong Park Hun-Sik Kim Dae-Kyeong Hyun Dae-Woo Jeong Yong-Suk Lee Sang-Kon Kim Young-Jo Kim Kwon-Bae
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Abstract
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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 stentspecific, prospective, all-comer registry, we evaluated 987 patients (1,342 lesions) who received an EES (XIENCE V¨Þ, 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 ¡Ã1 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%). Offlabel
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.
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KEYWORD
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Coronary artery disease, Drug-eluting stents, Off-label use
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