Long-term outcomes following off-label use of sirolimus-eluting stent

Abstract Objective To clarify the impact of off-label use of drug-eluting stent (DES) on 5-year outcomes. Background Studies on the outcomes of on- vs off-label use of DES have been limited by the duration of observation. Methods We analyzed 1937 patients from a multicenter registry that includes 95% of patients with 5-year follow-up data. We defined 10 variables as off-label indications according to the manufacturer's instructions for use, and 1665 of 1937 patients (86.0%) met the criteria for at least 1 off-label indication. Results At 5 years, there were no differences in the rates of death, myocardial infarction (MI), and stent thrombosis between off-label and on-label use. The frequency of major adverse cardiac events (MACE), target lesion revascularization (TLR), non-TL but target vessel revascularization (TVR), and target vessel failure were higher in the off-label only during the first year. Among the off-label, having 2 indications was associated with TVR hazard ratio (HR) 1.62; 95% confidence interval (95%CI), 1.09–2.36 and TLR (HR, 1.90; 95%CI, 1.30–2.85). Moreover, having ≥3 off-label indications increased the risk of MACE (HR, 1.70; 95%CI, 1.23–2.40) compared with on-label use. Thrombosis rates increased with the number of off-label indications; it was 0.32% with 1, 0.69% with 2, and 3.54% with ≥3 off-label indications ( p < 0.001). This trend was also seen with other outcomes, except for non-TL TVR. Patients with ≥3 off-label indications had a remarkably different clinical course. Conclusion Off-label use did not increase rates of death and MI as compared with on-label use, but the number of off-label indications influenced outcomes at 5 years.