Key result
Drug-eluting stents were initially approved based on trials in low-risk patients showing reduced restenosis, leading to widespread off-label use in complex subgroups.
Why the study?
Initial randomized trials of drug-eluting stents were conducted in lower risk patients with noncomplex lesions, but safety and effectiveness in more complex subgroups and off-label use remain uncertain.
T he randomized clinical trials leading to initial approval of drug-eluting stents (DES) by the United States Food and Drug Administration were conducted by design in a homogeneous group of lower risk patients with mostly noncomplex coronary lesions.1,2 These studies demonstrated a clear benefit in the reduction of restenosis without any evidence of a safety concern during 1 year follow-up.Shortly after approval of the sirolimus and paclitaxel-eluting stents, safety and effectiveness was reported from small nonrandomized studies in a variety of more complex patient and lesion subgroups and resulted in a large proportion of so-called off-label usage.3,
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Donald E. Cutlip (2008) conducted an editorial in ST Elevation Myocardial Infarction. Drug-Eluting Stents vs. Bare-Metal Stents was evaluated. Drug-eluting stents were initially approved based on trials in low-risk patients showing reduced restenosis, leading to widespread off-label use in complex subgroups.
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