TAXUS V
Slow-rate release polymer-based paclitaxeleluting stent compared with bare stent in
patients with single complex coronary lesions
Presented at
The American College of Cardiology
Scientific Sessions 2005
Presented by Dr. Gregg Stone
TAXUS V
1,156 patients with single complex coronary lesions
31% diabetic, 31% female, 33% received multiple stents
Mean stent length = 28 mm; Mean patient age = 63
Cocomitant medications: aspirin indefinitely, clopidogrel 6 months +
Paclitaxel- eluting stent
Bare metal stent
 Slow-release formulation
 2.25-4.0 mm in diameter
 8 – 32 mm in length
 2.25-4.0 mm in diameter
 8 – 32 mm in length
 n = 577
 n = 579
Endpoints:


Primary – Symptom-driven target vessel revascularization at 9 months
Secondary – 9 month late loss and overall MACE (cardiac death, target
vessel revascularization, Q-wave and non-Q-wave MI, stent thrombosis)
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ACC 2005
TAXUS V: Primary Endpoint
The primary endpoint of 9 month target vessel revascularization was lower in the TAXUS group
than in the bare metal stent group. The difference was driven by a significant reduction in target
lesion revascularization, with no difference in non-TLR between the two groups.
20%
17.3%
15%
15.7%
p =0.0003
p=0.018
12.1%
10%
%
8.6%
5%
0%
TVR
TLR
TAXUS
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Bare Stent
ACC 2005
TAXUS V Trial: Overall MACE
Overall MACE at 9 months
25%
p=0.008
21.2%
20%
15%
15.0%
10%
• The significant reduction in
overall MACE in the
paclitaxel-eluting stent group
was driven solely by a lower
rate of TVR. The two groups
showed no difference in all
other components of the
MACE endpoint, including
cardiac death, Q-wave and
non-Q-wave MI, and stent
thrombosis.
5%
0%
TAXUS
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Bare metal stent
ACC 2005
TAXUS V Trial: angiographic endpoints
In-stent late lumen loss
In-stent binary restenosis
p<0.0001
p<0.0001
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0.90
35%
31.9%
30%
25%
20%
0.49
15%
13.3%
10%
5%
Paclitaxel Stent
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Bare Stent
0%
Paclitaxel Stent
Bare Stent
ACC 2005
TAXUS V: Small-vessel subgroup
In a subgroup of 203 small-vessel patients (2.25 mm stents,) the primary endpoint of 9 month TVR
was lower (but not significantly) in the TAXUS group than in the bare metal stent group, driven by
a significantly lower rate of TLR. 9-month MACE rates were not significantly different between the
two groups.
30%
25%
26.9%
24.7%
p=0.03
p =0.23
18.9%
20%
16.0%
%
15%
10%
5%
0%
TVR
MACE
TAXUS
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Bare Stent
ACC 2005
TAXUS V: small-vessel subgroup
Among patients in the small-vessel subgroup, the paclitaxel-eluting stent was also associated
with significant reductions in 9 month binary restenosis and late-loss compared to treatment with
a bare metal stent. The groups showed statistically equal rates of stent thrombosis (1%).
50%
p=0.01
49.4%
0.7
p=0.004
0.61
0.6
40%
0.5
31.2%
mm
30%
20%
0.4
0.36
0.3
0.2
10%
0.1
0.0
0%
Binary restonosis
Paclitaxel Stent
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Bare Stent
Late-loss
Paclitaxel Stent
Bare Stent
ACC 2005
TAXUS V Trial: Large-vessel subgroup
Binary Restenosis at 9 months
14.4%
15%
p=0.016
10%
5%
0%
3.5%
TAXUS
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• In a subgroup of 202 large
vessel patients (4.0 mm
stents), there was no
difference in 9 month TLR,
TVR or MACE between the
two groups.
• The TAXUS stent was
associated with a significant
reduction in binary restenosis
compared to bare metal stent
at 9 months.
•Both groups had 0% stent
thrombosis at 9 months.
Bare metal stent
ACC 2005
TAXUS V Trial: Multiple-stent group
In a subgroup of 379 patients receiving multiple stents, the paclitaxel-eluting stent was associated
with a near significant increase in 9 month MACE due to a marked increase in non-Q-wave MIs in
the TAXUS stent group compared with the bare metal stent group. The increase in non-Q-wave MI
is probably driven by the significant increase in branch TIMI flow reduction in the TAXUS group.
41.9%
10%
p=0.016
40%
8.3%
p=0.047
5%
3.3%
28.6%
30%
20%
10%
0%
0%
9-month MACE
Paclitaxel Stent
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Bare Stent
9-month Branch TIMI flow reduction
Paclitaxel Stent
Bare Stent
ACC 2005
TAXUS V: Multiple-stent group
However, there were no differences between the TAXUS and bare metal stent groups in the
clinical endpoints of death, cardiac death, or stent thrombosis. The TAXUS stent was associated
with significantly improved angiographic endpoints of TLR, TVR , binary restenosis, and late loss.
57.8%
60%
50%
p =<0.0001
p =0.002
40%
p=0.0003
29.8%
28.2%
30%
20%
27.2%
16.2%
12.6%
10%
0%
9-month TLR
9-month TVR
TAXUS
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binary restenosis
Bare Stent
ACC 2005
TAXUS V Trial: Summary
• Among patients with single complex lesions, treatment with the slow-release paclitaxel-eluting
stent was associated with a significant reduction in the primary endpoint of 9-month target vessel
revascularization compared with treatment with bare metal stent.
• Earlier TAXUS studies showed a similar reduction in TVR with paclitaxel-eluting stents in more
simple lesions; this trial expands these findings to include more complex lesions, including longer
lesions and lesions requiring multiple and overlapping stents.
•The secondary angiographic endpoints of 9 month in-stent late lumen loss and in-stent binary
restenosis were significantly lower in the paclitaxel-eluting stent group compared with the bare
metal stent group.
• As in previous TAXUS trials, paclitaxel-eluting stents were not associated with a reduction in
other components of overall MACE, including the clinical endpoints of cardiac death or MI at 9
months.
• The overall findings of the trial held true for subgroups of both small and large vessel patients.
However, a third subgroup of patients receiving multiple stents showed a significant increase in
MACE (all of which were MI, all but one of which were non-Q-wave MI) and a significant increase
in branch TIMI flow reduction in the TAXUS stent group compared with the bare metal stent group.
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ACC 2005