A comparison of bare-metal and drug-eluting stents for off-label indications

Abstract

Background: Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown.

Methods: We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm.

Results: Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents.

Conclusions: Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.

Figure 1. Kaplan–Meier Curves for Outcome According to Stent Type (Drug-Eluting vs. Bare-Metal) and Label Indication (Off-Label vs. Standard Use)

Panel A shows the 1-year incidence of death, Panel B the 1-year incidence of myocardial infarction, Panel C the 1-year incidence of the composite end point of death or myocardial infarction, and Panel D the 1-year incidence of repeat revascularization (percutaneous coronary intervention or coronary-artery bypass grafting).

Figure 2. Safety and Efficacy Outcomes at 1 Year of Follow-up

Shown are the adjusted hazard ratios and 95% confidence intervals (CI) for safety and efficacy outcomes at 1 year for drug-eluting stents and for bare-metal stents (reference category), stratified according to off-label or standard use (Panel A) or stratified according to off-label characteristic (Panel B). Models were adjusted for age, sex, circumstances of the procedure (elective, urgent, or emergency), history or no history of percutaneous coronary intervention (PCI), history or no history of coronary-artery bypass grafting, presence or absence of chronic kidney disease, history or no history of congestive heart failure, presence or absence of diabetes mellitus, number of involved vessels, number of lesions attempted, reason for revascularization, and medical regimen at discharge from the hospital. In both panels, the solid symbols represent the adjusted hazard ratios, and the horizontal lines indicate the 95% CI.