TAXUS IV研究
TAXUS IV 2-Year Clinical Results
The safety and effectiveness of the TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent System have been established up to 12 months in the treatment of de novo lesions ≤ 28mm in length in native coronary arteries
≥ 2.5 to ≤ 3.75mm in diameter. Please refer to the directions for use for the clinical experience observed in
three clinical studies TAXUS IV, II and I.
TAXUS and Express are trademarks of Boston Scientific Corporation or its affiliates. Copyright ? 2004 by Boston Scientific Corporation or its affiliates. All rights reserved.
TAXUS IV Clinical Trial: Patient Flow
TAXUS Stent (n=662)
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
TAXUS Stent (n=639)
TAXUS Stent (n=625)
TAXUS IV Clinical Trial: Baseline Clinical Features
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
The safety and effectiveness of the TAXUS? Express? Stent
have not been established in patients with diabetes.
TAXUS IV Clinical Trial: 2-Year Revascularization
P<0.0001
P<0.0001
P<0.0001
P=0.0002
P=0.01
P<0.0001
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
100
90
70
75
80
95
85
TLR-free (%)
0
100
200
300
400
500
600
700
750
50
150
250
350
450
550
650
Days
TAXUS
Control
P<0.0001
24 mos.
12 mos.
9 mos.
TAXUS IV Clinical Trial: Freedom From TLR to 2 Years
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
P<0.0001
89.4%
78.9%
83.1%
93.1%
9 mos.
87.9%
95.3%
TAXUS IV Clinical Trial: Freedom From TVR to 2 Years
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
P<0.0001
85.3%
75.1%
12 mos.
79.8%
89.4%
9 mos.
84.9%
91.5%
TAXUS IV Clinical Trial: Freedom From MACE to 2 Years
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
TAXUS IV Clinical Trial: Stent Thrombosis
P=0.77
1.1%
(n=7)
0.8%
(n=5)
* All within 1-6 months
Stent Thrombosis, %
TAXUS
Stent
CONTROL
In-Hospital
31 days – 1 Year*
Discharge – 30 Days
1 – 2 Years
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
TAXUS Stent N=3
Circumstances
ASA/Plavix?
status
TAXUS IV Clinical Trial: Stent Thromboses Between 1 and 2 Years
Plavix is a trademark of Sanofi-Synthelabo Corp.
TAXUS IV Clinical Trial: 2-Year Adverse Cardiac Events
P=0.67
P<0.0001
P=0.50
P<0.0001
P<0.0001
P<0.0001
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
P<0.0001
P=0.026
P=0.0004
TAXUS IV Clinical Trial: Subset Data – 2 Year TLR
The safety and effectiveness of the TAXUS? Express? Stent have not been established
in patients with coronary artery reference vessel diameter less than 2.5mm.
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
P<0.0001
P=0.009
P<0.0001
The safety and effectiveness of the TAXUS? Express? Stent have not been
established in patients with coronary artery in lesions longer than 28mm.
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
TAXUS IV Clinical Trial: Subset Data – 2 Year TLR
TLR (%)
Lesion Length (mm)
Control
TAXUS Stent
> 3.0
2.5-3.0
< 2.5
RVD (mm)
Tertile analysis
The safety and effectiveness of the TAXUS? Express? Stent have not been established in patients with coronary artery reference vessel diameter less than 2.5mm or in lesions longer than 28mm.
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
TAXUS IV Clinical Trial: Subset Data – 2 Year TLR
P<0.0001
P=0.08
P=0.0005
The safety and effectiveness of the TAXUS? Express? Stent
have not been established in patients with diabetes.
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
TAXUS IV Clinical Trial: Subset Data – 2 Year TLR
P<0.0001
P<0.0001
N=269
N=264
N=381
N=396
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
TAXUS IV Clinical Trial: Subset Data – 2 Year TLR
12 mo
9 mo
24 mo
Control
11.3
n=652
P<0.0001
14.7
p<0.0001
17.4*
P<0.0001*
N=652
22.0*
N=163
P=0.0005*
17.7*
N=54
P=0.0786*
25.4*
P<0.0001*
N=212
22.5*
P=0.0092*
n=99
19.6
P=0.0016
16.0
N=163
P=0.002
13.0
n=54
P=0.32
16.7
P=0.12
15.4
n=214
P<0.0001
20.1
p<0.0001
18.6
N=97
P<0.0001
21.6
P=0.0014
Diabetics
Insulin Treated
Diabetics
9 mo
12 mo
24 mo
4.2
7.1
5.3
5.5
8.0*
N=155
6.2*
N=51
6.1*
N=203
8.9*
N=91
Small
Vessel
<2.5mm
Long Lesion
>20mm
All Patients
TLR
TLR
TLR
TLR
TLR
5.9
5.6*
N=662
The safety and effectiveness of the TAXUS? Express? Stent have not been established in patients
with coronary artery reference vessel diameter less than 2.5mm, in lesions longer than 28mm or in
patients with diabetes.
TAXUS IV Clinical Trial: Subset Data % TLR to 24-month
* Kaplan-Meier estimate (log-rank) 2 year
9-Month and 12-Month TAXUS IV Clinical Trial TLR calculated as Fischer ITT analysis
5.2
n=155
3.0
n=662
5.9
n=51
3.3
n=91
3.4
n=206
Paclitaxel-
Eluting
Stent***
TAXUS IV Clinical Trial- TAXUS? Express? Stent / Control- Express? Stent
At 2-year follow-up, the incremental benefits of having received the TAXUS stent rather than a bare metal stent continue to increase, with no apparent evidence of late catch-up.
TAXUS-IV Clinical Trial: 2-Year Conclusion
INDICATIONS
The TAXUS Express2 Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions <28 mm in length in native coronary arteries >2.5 to <3.75mm in diameter.
CONTRAINDICATIONS
Use of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System is contraindicated in patients with:
Known hypersensitivity to paclitaxel or structurally related compounds.
Known hypersensitivity to the polymer or its individual components.
Coronary Artery Stenting is contraindicated for use in:
Patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
WARNINGS
To maintain sterility, the inner package should not be opened or damaged prior to use.
The use of this product carries the risks associated with coronary artery stenting, including
subacute thrombosis, vascular complications, and/or bleeding events. Patients with known hypersensitivity to 316L stainless steel may suffer an allergic reaction to this implant.
Potent