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| * These
news are selected from 'TCT Daily (2004)' provided
by Cardiovascular Research Foundation (CRF). |
After two years of follow-up,
the incremental benefits of the Taxus stent vs.
bare-metal stents continue to increase with no apparent
evidence of late catch-up, according to results
of TAXUS IV presented here by CRF Vice-Chair man
Gregg Stone, MD, of Columbia University Medical
Center.
TAXUS IV enrolled 1,314 patients undergoing elective
stenting at 73 U.S. centers. Patients were randomized
to a paclitaxel-eluting stent or an identical appearing
bare-metal stent, with follow-up occurring at one,
four and nine months, and then annually for up to
five years.
Mean age of patients was about 62 years; and 72%
were men. Mean reference vessel diameter was 2.75
mm in both groups, and mean lesion length was 13.4
mm.
Implantation of the polymer-based, slow rate-release
paclitaxel-eluting stent (Taxus, Boston Scien tific)
in de novo coronary lesions is safe with no overall
increased risk of stent thrombosis.
Taxus stents also reduced clinical restenosis, resulting
in reduced rates of bypass graft surgery and repeat
percutaneous intervention. This result was maintained
across a wide range of complex patients and lesions
including small vessels, long lesions and patients
with diabetes.
At two years, patients in the TAXUS stent group
had a 94.4% rate of freedom from target lesion revascularization,
compared to an 82.6% rate in controls (P<.0001).
Freedom from target vessel revascularization at
two years was similar at 89.4% in the treatment
group and 78.9% in the control group (P<.0001).
Rate of revascularization procedures at two years
was also lower in the Taxus group as compared to
controls.
Stent thrombosis rates were similar between the
two groups at two years: 1.1% in the Taxus group
vs. 0.8% in the control group (P=.77). Stone said
that this may be due to lack of aspirin or clopidogrel
(Plavix, Bristol-Myers Squibb) in these patients.
However, there was no difference in cardiac death
or MI. Significant reductions in TLR were still
present in all categories of reference vessel diameter
and lesion length.
Patients with diabetes also had significant reductions
in TLR at two years with Taxus stents (8% vs. 22%,
P=.0005) but the difference was not significant
in insulin-dependent diabetics (6.2% vs. 17.7%,
P=.08). |
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