Off-label use of stents: bare-metal versus drug-eluting stents.
Drug-eluting stents (DES) became the default strategy for percutaneous revascularization due to their improved intermediate-term outcomes when compared with bare-metal stents (BMS) in the pivotal randomized, controlled trials. The excellent results of DES in on-label or US FDA-approved indications led to extrapolation of the results to more complex situations that were excluded from initial pivotal trials; such as off-label indications. Safety concerns began to grow after reports of increased late thrombosis and possibly associated increased death and myocardial infarction with DES, especially in the off-label situations. Recently, however, several important published registries have calmed some of those uncertainties and reassured the cardiology community of the safety and efficacy of DES compared with BMS. There is an overall poorer outcome with off-label use of any stent (BMS or DES) compared with standard or on-label use. This difference in outcome is most likely related to patient or specific coronary lesion characteristics or comorbidities that predispose an individual to adverse outcomes regardless of the stent type used. It is accepted now that DES use does result in a small increased risk of late thrombosis, but that risk is offset by a significant reduction in restenosis. Overall, the current data suggest that the use of DES in most lesion subsets is at least as safe as and clearly more efficacious than use of BMS in similar situations.
Girod
John P
JP
Center for Interventional Cardiology Research, Cardiovascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. girodjp@upmc.edu
Mulukutla
Suresh R
SR
Marroquin
Oscar C
OC
D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000628:therapy; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control; D003331:Coronary Vessels / Q000033:anatomy & histology; D004348:Drug Labeling; D054855:Drug-Eluting Stents / Q000009:adverse effects; D006801:Humans; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012307:Risk Factors; D012449:Safety; D015607:Stents; D013927:Thrombosis / Q000209:etiology