Long-Term Results With the Off-Label Use of Paclitaxel-Eluting Stents

Introduction and objectives. Little information is available about the results obtained with the off-label use of drug-eluting stents. Our aim was to investigate clinical findings on long-term follow-up. Methods. The study included 604 consecutive patients who received ≥ 1 paclitaxel-eluting stents (PES) at our catherization laboratory between June 2003 and February 2005. Patients were divided into 2 groups according to whether stent use was on-label or off-label as defined by current practice. The primary study endpoints were the combination of death and non-fatal acute myocardial infarction (AMI) and the combination of death, AMI and target-vessel revascularization (TVR). Secondary endpoints were these events individually and late stent thrombosis (ST). Results. During the median follow-up period of 34.3 months (interquartile range, 8.6 months), PESs had been used off-label in the majority of patients (ie, 464, 76.8% of the sample) and their use was associated with an increased risk of death or AMI (hazard ratio [HR]=2.2; 95% confidence interval [CI], 1.2-4) and of death, AMI or TVR (HR=1.8; 95% CI, 1.1-3). There was no significant difference in individual events (ie, death, AMI, or TVR). The group who used stents off-label had poorer clinical characteristics (ie, older age, and higher likelihoods of previous AMI or previous revascularization and multivessel disease), as well as a higher incidence of ST (5% vs 0; log-rank test, P=.015). Conclusions. The off-label use of PESs was associated with an increased risk of a combined clinical endpoint during long-term follow-up. Further studies are needed to determine the efficacy and safety of these devices in these settings.