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

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.