A Comparison of Bare-Metal and Drug-Eluting Stents for Off-Label Indications
Oscar C. Marroquin, M.D., Faith Selzer, Ph.D., Suresh R. Mulukutla, M.D., David O. Williams, M.D., Helen A. Vlachos, M.Sc., Robert L. Wilensky, M.D., Jean-François Tanguay, M.D., Elizabeth M. Holper, M.D., J. Dawn Abbott, M.D., Joon S. Lee, M.D., Conrad Smith, M.D., William D. Anderson, M.D., Sheryl F. Kelsey, Ph.D., and Kevin E. Kip, Ph.D.
Background Recent reports suggest that off-label use of drug-elutingstents is associated with an increased incidence of adverseevents. Whether the use of bare-metal stents would yield differentresults is unknown.
Methods We analyzed data from 6551 patients in the NationalHeart, Lung, and Blood Institute Dynamic Registry accordingto whether they were treated with drug-eluting stents or bare-metalstents and whether use was standard or off-label. Patients werefollowed for 1 year for the occurrence of cardiovascular eventsand 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 wellas use in patients with a reference-vessel diameter of lessthan 2.5 mm or greater than 3.75 mm or a lesion length of morethan 30 mm.
Results Off-label use occurred in 54.7% of all patients withbare-metal stents and 48.7% of patients with drug-eluting stents.As compared with patients with bare-metal stents, patients withdrug-eluting stents had a higher prevalence of diabetes, hypertension,renal disease, previous percutaneous coronary intervention andcoronary-artery bypass grafting, and multivessel coronary arterydisease. One year after intervention, however, there were nosignificant differences in the adjusted risk of death or myocardialinfarction in patients with drug-eluting stents as comparedwith those with bare-metal stents, whereas the risk of repeatrevascularization was significantly lower among patients withdrug-eluting stents.
Conclusions Among patients with off-label indications, the useof drug-eluting stents was not associated with an increasedrisk of death or myocardial infarction but was associated witha lower rate of repeat revascularization at 1 year, as comparedwith bare-metal stents. These findings support the use of drug-elutingstents for off-label indications.
Source Information
From the Cardiovascular Institute (O.C.M., S.R.M., J.S.L., C.S., W.D.A.) and the Department of Epidemiology, Graduate School of Public Health (F.S., H.A.V., S.F.K.), University of Pittsburgh, Pittsburgh; Rhode Island Hospital, Providence (D.O.W., J.D.A.); Hospital of the University of Pennsylvania, Philadelphia (R.L.W.); Montreal Heart Institute, Montreal (J.-F.T.); University of Texas Southwestern Medical Center, Dallas (E.M.H.); and University of South Florida, Tampa (K.E.K.).
Address reprint requests to Dr. Marroquin at the Cardiovascular Institute, University of Pittsburgh Medical Center, 200 Lothrop St., F392, PUH, Pittsburgh, PA 15213, or at marroquinoc{at}upmc.edu.
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