| Drug-eluting
stents are a hot topic in interventional cardiology and potentially
revolutionary in the treatment of coronary artery disease, but
the ideal stent coating has yet to be determined.
Investigators
testing various coatings discussed their research at a press
conference on Sunday. Researchers from France and Brazil presented
positive data from their clinical studies using sirolimus-eluting
stents. But a trial from Germany showed negative results with
heparin-coated stents.
The
heparin-coated stent trial was described by Michael Haude,
MD, Med Klinik II, University of Essen, Essen, Germany. In
the trial, 600 patients with recurrent small-vessel disease
were randomized to receive PTCA, an uncoated JOSTENT Flex
stent, or the same stent with a heparin coating.
Median
lumen diameters at six months were almost identical, at 1.34
mm for PTCA, 1.47 mm for the uncoated stent, and 1.45 mm for
the coated stent. There were no deaths in the PTCA group but
two each in the stent trial arms. And there was one thrombotic
event each in the stent arms versus none in the PTCA arm.
We
conclude that the heparin-coated stent does not provide any
angiographic or clinically-related benefit in small native
coronary arteries, Dr. Haude said.
More
promising data come from two studies using stents coated with
the naturally-occurring antibiotic sirolimus.
Jean
Fajadet, MD, Clinique Pasteur, Toulouse, France, reported
on the 210-day followup of the RAVEL study, which found no
late loss and no restenosis in the 120 patients randomized
to receive a sirolimus-eluting Bx Velocity balloon-expandable
stent. This compares very favorably with an average late loss
of 0.8 mm and restenosis rate of 26 percent among the 118
controls who received the uncoated stent.
Dr.
Fajadet said especially impressive was that patients with
diabetes who were treated with the coated stent also had no
late loss or restenosis compared with a late loss of 0.82
mm and restenosis rate of 42 percent for the controls.
And
survival at one year was 94 percent with the sirolimus stent
versus 71 percent for the controls.
Use
of the sirolimus stent is safe and there were no deaths related
to its use, Dr. Fajadet said.
Results
from another sirolimus-coated stent trial were similarly encouraging.
Jose Eduardo Sousa, MD, Institute Dante Pazzanese of Cardiology,
Sao Paulo, Brazil, said the two-year followup of implantation
with the sirolimus-eluting stent showed no mortality and no
restenosis in the stent.
At
two years followup, the sirolimus-eluting stent continues
to be a major breakthrough in the fight against restenosis,
Dr. Sousa said.
He
presented data on 45 patients followed by serial angiography
and ultrasound examination on multiple occasions during the
two-year followup.
The
percent of arterial blockage before treatment was 61 percent,
Dr. Sousa said. Immediately post procedure it was 4.2 percent,
and 1.4 percent at two-year followup.
These
angiographic results were confirmed by intravascular ultrasound
that demonstrated minimal scar-tissue growth in the stent,
Dr. Sousa said. The clinical benefits observed after
placement of the sirolimus stent appear durable at late followup.
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