Abstract 2142: Off-Label Use of Drug-Eluting Stents: Safety and Efficacy Compared to Bare Metal Stents. A Report From the NHLBI Dynamic Registry.
Introduction: Recent reports suggest that off-label use of drug-eluting stents (DES) is associated with an increased incidence of adverse events. Whether use of bare metal stents (BMS) for such patients (pts) would yield different results is unknown. Accordingly we analyzed 6545 pts in the NHLBI Dynamic Registry according to treatement with DES or BMS and whether use was on- or off-label.
Methods: Off-label use was defined as use in restenotic lesions, graft lesions, reference diameter <2.5mm or >3.75mm, or lesion length >30mm, left main, ostial, bifurcations or total occlusions.
Results: Off-label use accounted for 55% of the BMS pts (n=2110) and 48% of the DES pts (n=1306). Off-label pts had more high-risk clinical profiles at baseline than on-label pts, as did DES pts with higher prevalences of diabetes, hypertension, renal disease, prior PCI and CABG, and more multivessel CAD. When used off-label, DES resulted in a non-significantly lower 1-year risk of death/MI and significantly lower risk of repeat revascularization compared to BMS (figure⇓).
Conclusion: Both on- and off-label use of DES was not associated with an increased risk of death or MI while the risk of repeat revascularization was lower for both subsets when compared to BMS. This investigation indicates that for pts with off-label indications, use of DES is preferred to BMS.