Author Affiliation: Cardiovascular Diseases
and Internal Medicine, Mayo Clinic and Foundation, Rochester, Minn.
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 were not the focus of these early trials were those
with clinically important stenoses of small coronary arteries.
Holmes DR. Stenting Small Coronary Arteries: Works in Progress. JAMA. 2004;292(22):2777–2778. doi:10.1001/jama.292.22.2777
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