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Works in Progress

David R. Holmes, Jr, MD

JAMA. 2004;292:2777-2778.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Interventional cardiology has a long and rich tradition of randomized clinical trials, the results of which have dramatically improved patient care. In the past few years, attention has particularly focused on drug-eluting stents, which have quickly become predicate devices (ie, against which new stents are compared). In the case of sirolimus-eluting stents, device approval was based in large measure on the 2 initial randomized clinical trials of RAVEL¹ and SIRIUS.² Based on the dramatic improvement in reducing restenosis with these devices demonstrated in these 2 trials, patients and physicians alike have embraced this new technology and physicians have used drug-eluting stents in subsets of patients for whom the data from trials were very limited. Early randomized trials of any device or drug typically target restricted "ideal" patient groups; this was certainly the case with the early drug-eluting stent trials. An important subset of patients that . . . [Full Text of this Article]

Author Affiliation: Cardiovascular Diseases and Internal Medicine, Mayo Clinic and Foundation, Rochester, Minn.

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