Abstract 2562: Long-Term Clinical Outcomes and Stent Thrombosis After On-Label versus Off-Label Utilization of Drug-Eluting Stents
Background: There may be an increased risk of stent thrombosis (ST) at 1 year with off-label use of drug-eluting stents (DES), as compared with on label use. However, data are limited regarding the long-term outcomes (>1year) with the off-label use of DES.
Methods: We evaluated 3,097 patients treated with at least 1 DES from January 2003 to March 2006 in clinical practice. We applied a classification of ST by the Academic Research Consortium (ARC). The population was divided into 2 groups based on the presence of at least 1 of 10 off-label criteria by the approval of current US Food and Drug Administration.
Results: Of 3,097 patients receiving DES, 2677 (85%) received stents for off-label indications. During 4 year follow-up, adjusted the risk of death, MI, and the composite of death/MI was not statistically different between on-label and off-label (death; hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.32–1.41; P=0.3, MI; HR 1.9; 95% CI 0.6–6.37; P=0.26, and the composite of death/MI; HR 0.89; 95% CI 0.48–1.65; P=0.72, figure 1⇓). The risk of definite or probable stent thrombosis was not significantly higher in patents with off-label use (HR 1.42; 95% CI 0.4–4.71; P=0.55, figure 2⇓).
Conclusions; In the current practice, off-label use of DES was common. Compared with on-label use, the long-term risk of mortality, MI, or stent thrombosis was not higher even in off-label use.