TCT
2009
Gregg W. Stone, MD, of Columbia University Medical Center, New
York, presented results showing that the everolimus-eluting stent significantly reduced target
lesion failure - the study’s primary endpoint - at one-year follow-up
compared with a paclitaxel-eluting stent (everolimus 4.2% vs. paclitaxel 6.8%) in the SPIRIT IV
trial.
While overall results favored the everolimus-eluting stent (Xience V, Abbott Vascular), results in patients with
diabetes did not.
Stone said there were significant reductions in TLF,
target vessel failure and MACE for patients who received the everolimus-eluting stent (n=2,458) vs.
paclitaxel-eluting stent (n=1,229) through one year.
The everolimus-eluting stent also outperformed the paclitaxel-eluting stent (Taxus Express, Boston Scientific) for a secondary endpoint of
ischemia-driven TLR reduction, with a relative risk reduction of 45% (RR=0.55;
95% CI, 0.38-0.78). In another secondary endpoint, a composite of cardiac death
or MI at one year, there was no difference between the two stents (RR=0.69; 95%
CI, 0.46-1.04).
SPIRIT IV also included a large number of patients with diabetes (32.2%,
n=1,185) compared with SPIRIT III (29%, n=290), but results were not as
desirable as some hoped, according to comments during the discussant portion of
the presentation.
“This clearly demonstrates that we have a novel, effective …
stent platform out to a year and within that, we have greater precision and
understanding of all the components,” said Mitchell Krucoff, MD,
professor of medicine and cardiology at Duke University Medical Center.
“Which of those could be tweaked to have a greater impact in diabetes?
It’s important that we continue to wrestle with the science of
revascularization in diabetics.”
Stone said there was a comparable rate of TLF for
the everolimus-eluting stent and paclitaxel-eluting stent (6.4% Xience V vs. 6.9% Taxus; P=0.80). He said that
outcomes in patients with diabetes should be improved through future
development of novel drugs and stent design. – by Judith Rusk
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