Abstract 5990: Off-Label Use of Drug-Eluting Stents Is Associated with a Reduction in All-Cause Mortality Compared with Bare-Metal Stents: Results from a Combined Analysis
Background: Several recent analyses have suggested that off-label (non-FDA approved) use of drug-eluting stents (DES) is associated with increased adverse events compared with their on-label use. However, it is unknown whether the use of bare metal stents (BMS) is better than use of DES for similar off-label indications.
Methods: We performed a pooled analysis of all registries that included patients who received either a DES or BMS, and provided data on their use for > 1 non-FDA approved indication. We pooled data across studies using random effects models.
Results: A total of 5 registries, which included 21,029 patients, were identified. Among the off-label indications included were STEMI (12.6%), in-stent restenosis (16.0%), vein graft interventions (16.3%), ostial lesions (16.4%) and chronic occlusions (18.2%). The weighted mean duration of follow-up was 15.6 months (range 9 to 36). Compared with BMS, DES were associated with a significant reduction in all-cause mortality (4.6% vs. 8.6, Risk Ratio [RR]= 0.55, 95% CI 0.49 – 0.61, p<0.0001), non-fatal MI (3.5% vs. 5.7%, RR = 0.70, 95% CI 0.60 – 0.81, p<0.0001), and target vessel revascularization (TVR) (7.6% vs. 13.6%, RR=0.71, 95% CI 0.65– 0.78, p<0.0001)(Figure 1⇓). Rates of stent thrombosis were similar for both groups.
Conclusions: Patients who receive off-label DES have significantly better long-term outcomes, including mortality, when compared to those receiving BMS for similar indications. Although associated with increased adverse events as compared to on-label use, the magnitude and consistency of benefit with off-label DES warrants further randomized investigation.