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.
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