Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or MI but was associated with a lower rate of repeat revascularization at one year, as compared with bare-metal stents, according to a study published in the Jan. 24 issue of the New England Journal of Medicine.
Despite recent reports suggesting that off-label use of drug-eluting stents (DES) is associated with an increased incidence of adverse events, the researchers sought out to discover whether the use of bare-metal stents (BMS) would yield different results.
Oscar C. Marroquin, MD, from the Cardiovascular Institute at the University of Pittsburgh Medical Center in Pittsburgh, and colleagues, conducted the study.
The researchers analyzed data from 6,551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry, according to whether they were treated with DES or BMS, and whether use was standard or off-label. The patients were followed for one year for the occurrence of cardiovascular events and death.
The 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, according to the researchers.
The researchers reported that off-label use occurred in 54.7% of all patients with BMS and 48.7% of patients with DES. As compared with patients with BMS, patients with DES 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, there were no significant differences in the adjusted risk of death or MI in patients with DES as compared with those with BMS, whereas the risk of repeat revascularization was significantly lower among patients with DES, the authors wrote.
The authors noted that their findings support the use of DES for off-label indications.