Cedars-Sinai Medical Center, David Geffen School of Medicine, and University of California, Los Angeles, Los Angeles, California 90048, USA.
Interventional cardiologists have quickly replaced bare metal stents with intravascular drug-eluting stents for treating and preventing restenosis, largely on the basis of empirical evidence that shows profound reduction in angiographic and clinical restenosis. A critical reassessment of the published evidence, however, suggests that the putative superiority of intravascular drug-eluting stents is founded on questionable premises, including 1) overestimation of restenosis benefit, 2) underestimation of the risk for stent thrombosis, 3) overreliance on "soft" rather than "hard" outcomes (need for repeated revascularization vs. death or myocardial infarction), and 4) the attendant overestimation of cost-effectiveness. Because the long-term incremental risks, benefits, and costs of drug-eluting stents have not yet been optimally evaluated in a broad spectrum of patient and lesion cohorts, the rational role of these devices in clinical management warrants reappraisal.