1. Updated 3-Year Meta-Analysis of the TAXUS Clinical Trials Safety and Efficacy Demonstrated in 3,445 Randomized Patients
Time allocation for this talk is 15 minutes. Approximately 25 – 30 slides.
Gregg W. Stone, MD
Columbia University Medical Center
The Cardiovascular Research Foundation

2. Conflict of Interest Disclosure
The following relationships exist related to this presentation:
Consultant/Advisory Board (Boston Scientific)

3. TAXUS II, IV, V, VI: N=3,445
10.5
13.4
17.2
20.6
2.75
2.69
2.79

4. TAXUS II, IV, V, VI: N=3,445
N/A

5. Analysis of All Pts, TAXUS II, IV, V, VI
Control (n=1727)
TAXUS (n=1718)
All Patients (n=3445)

6. Baseline Characteristics Overall Population, TAXUS II, IV, V, VI
Control (n=1727)
TAXUS (n=1718)
P Value
Diabetes
24.0%
23.2%
0.60
RVD (mm)
2.73±0.51
2.74±0.51
0.84
Lesion length (mm)
15.1±8.0
15.2±7.9
0.85
Type B2/C lesions
68.3%
67.0%
0.72
Multiple stents
19.5%
20.3%
0.58
QCA RVD <2.5mm
34.1%
33.7%
0.83
Visual length >26mm
14.6%
15.4%
0.54

7. TAXUS Trials Meta-Analysis: FU Duration
1 yr
2 yr
3 yr
ACC’05
TCT’05

8. TAXUS Meta-Analysis Low Frequency Long-Term Safety Events Efficacy
3445 intent-to-treat patients overall
1727 bare metal Express vs TAXUS Express
2289 with 2-year follow-up
1843 with 3-year follow-up
2627 pts with angiographic follow-up
1040 pts with IVUS follow-up
Low Frequency
Safety Events
Long-Term
Efficacy
Overall
Subgroups

9. Freedom from Stent Thrombosis Days Since Index Procedure
Stent Thrombosis out to 3-Years Overall Population, TAXUS II, IV, V, VI 9m 6m
12m
2 yr
3 yr
100%
90%
80%
Freedom from Stent Thrombosis
TAXUS N = 1718
Control N = 1727
100
200
300
400
500
600
700
800
900
1000
1095
Days Since Index Procedure

10. Freedom from Stent Thrombosis Days Since Index Procedure
Stent Thrombosis out to 3-Years Overall Population, TAXUS II, IV, V, VI 9m 6m
12m
2 yr
3 yr
100%
90%
80%
98.7% (T)
99.2% (C)
p = 0.36
Stent Thrombosis
Between 6 Mo and 2 Yrs
N=0 Control
N=8 TAXUS
Stent Thrombosis
Between 2 and 3 Years
N=1 Control
N=0 TAXUS
Freedom from Stent Thrombosis
TAXUS N = 1718
Control N = 1727
100
200
300
400
500
600
700
800
900
1000
1095
Days Since Index Procedure

11. Freedom from Cardiac Death Days Since Index Procedure
3-Year Freedom from Cardiac Death Overall Population, TAXUS II, IV, V, VI 9m 6m
12m
2 yr
3 yr
100%
90%
80%
70%
98.0% (C)
97.9% (T)
P=0.81
Freedom from Cardiac Death
TAXUS N = 1718
Control N = 1727
100
200
300
400
500
600
700
800
900
1000
1095
Days Since Index Procedure

12. 3-Year Freedom from Any Death Overall Population, TAXUS II, IV, V, VI
2 yr
3 yr
100%
90%
80%
70%
60%
95.7% (C)
95.4% (T)
p=0.89
Freedom from Any Death
TAXUS N = 1718
Control N = 1727
100
200
300
400
500
600
700
800
900
1000
1095
Days Since Index Procedure

13. 3-Year Freedom from MI Overall Population, TAXUS II, IV, V, VI
2 yr
3 yr
100%
90%
80%
70%
60%
93.6% (C)
93.4% (T)
p=0.96
Freedom from MI
TAXUS N = 1718
Control N = 1727
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

14. 3-Year Freedom from TLR Overall Population, TAXUS II, IV, V, VI
2 yr
3 yr
100%
90%
80%
70%
60%
90.6% (T)
Δ9.1%
Δ10.5%
Freedom from TLR
80.1% (C)
TAXUS N = 1718
Control N = 1727
p<0.0001
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

15. % Binary Restenosis at 6-9 Months All Patients, TAXUS II, IV, V, VI (N=3,445)
Control (n=1727)
TAXUS (n=1718)
p<0.0001
p<0.0001
69%
59%
Patients (%)
338/1227
105/1247
368/1229
154/1249
In-Stent
Analysis Segment

16. Effect of Vessel Size on 3-Year TLR TAXUS II, IV, V, VI MetaAnalysis
2 yr
3 yr
100%
90%
80%
70%
60%
>3.0
≤2.5
>3.0
Freedom from TLR
Control
TAXUS
RVD >3.0
RVD2.5≤3.0
RVD≤2.5
P=0.0001
P<0.0001
≤2.5
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

17. Effect of Lesion Length on 3-Year TLR TAXUS II, IV, V, VI MetaAnalysis
2 yr
3 yr
100%
90%
80%
70%
60%
<18
18-26
>26
18-26
Freedom from TLR
<18
Control
TAXUS
>26mm
18-26mm
<18mm
P=0.002
P=0.0006
P<0.0001
>26
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

18. Effect of Vessel Size and Lesion Length on 3-Year TLR
Control
TAXUS
RVD in terciles (mm)
3-Year TLR (%)
≤2.5
>2.5<3.0
≥3.0
<11
≥17
<11
≥17
≥11≤17
≥11≤17
Lesion Length in terciles (mm)

19. Days Since Index Procedure
Effect of Diabetic Status on 3-year TLR TAXUS II, IV, V, VI MetaAnalysis 9m
12m
2 yr
3 yr
100%
90%
80%
70%
60%
NonD
Diab
NonD
Freedom from TLR
Diab
Control
TAXUS
Non-Diabetic
P<0.0001
Diabetic
P<0.0001
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

20. Effect of Diabetic Status on 3-year TLR TAXUS II, IV, V, VI MetaAnalysis
Control
TAXUS
p<0.0001
p<0.0001
p=0.005
52%
53%
61%
3-Year TLR (%) N=
1312
1319
279
279
136
120
Diabetic
(Oral Agents)
Diabetic
(Insulin-Requiring)
Non-Diabetic

21. Single vs. Multiple Stents TAXUS II, IV, V, VI Meta-Analysis
Single Stents (n=2740)
Control (n=1378)
TAXUS (n=1362)
All Patients
Multiple Stents (n=684)
Control (n=336)
TAXUS (n=348)

22. Baseline Characteristics Multiple Stent Patients, TAXUS II, IV, V, VI
Control n=336
TAXUS n=348
P value
Type C lesions
70.3
68.7
0.67
RVD (mm)
2.72±0.55
2.71±0.52
0.73
Diabetes (%)
28.6
28.2
0.93
Lesion length (mm)
23.7±10.4
23.6±9.7
0.95
Stent length (mm)
41.6±11.4
41.7±10.7
0.83
Stent:lesion Ratio
2.07±1.14
2.07±1.11
0.92
Overlap stents (%)
85.3
81.7
0.30

23. MACE, Cumulative to 30 Days Multiple Stent Patients, TAXUS II, IV, V, VI
Control (n=336)
TAXUS (n=348)
p=1.00
p=1.00
p=0.015
p=0.027
p=1.00
p=1.00
Adverse events (%)
Cardiac
Death
Q-Wave MI
Non-Q
Wave MI
MACE
All
Death ST

24. MACE, Cumulative to 3 Years Multiple Stent Patients, TAXUS II, IV, V, VI
Control (n=336)
TAXUS (n=348)
p=0.67
p=0.49
p=0.21
p=0.0002
p=0.03
p=0.51
Adverse events (%)
Cardiac
Death
Q-Wave MI
Non-Q
Wave MI
MACE
All
Death ST

25. Freedom from cardiac death Days Since Index Procedure
3-Year Freedom from Cardiac Death Multiple Stent Patients, TAXUS II, IV, V, VI 9m
12m
2 yr
3 yr
100%
90%
80%
70%
60%
99.1% (T)
98.4% (C)
Freedom from cardiac death
p=0.67
TAXUS N = 348
Control N = 336
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

26. 3-Year Freedom from MI Multiple Stent Patients, TAXUS II, IV, V, VI
2 yr
3 yr
100%
90%
80%
70%
60%
90.0% (T)
Freedom from MI
88.3% (C)
p=0.40
TAXUS N = 348
Control N = 336
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

27. 3-Year Freedom from TLR Multiple Stent Patients, TAXUS II, IV, V, VI
2 yr
3 yr
100%
90%
80%
70%
60%
88.5% (T)
Δ16.6%
Δ19.9%
Freedom from TLR
p<0.0001
TAXUS N = 348
Control N = 336
68.6% (C)
1095
500
600
700
800
900
1000
100
200
300
400
Days Since Index Procedure

28. TLR up to 3-Years: Subgroup Summary All Pts, TAXUS II, IV, V, VI Meta-analysis
HR [95% CI] HR
TAXUS
Control
P Value
All
0.42
9.3%
19.8%
<0.0001
RVD ≤2.5
0.40
12.3%
27.4%
RVD ≤3.0
0.47
9.1%
17.7%
RVD >3.0
0.43
6.4%
13.2%
0.0002
Lsn Length <18
8.5%
19.0%
Lsn Length 18-26
0.46
11.3%
18.5%
0.0008
Lsn Length >26
0.44
13.0%
28.2%
0.003
Non-Diabetic
8.8%
Diabetic-Oral
0.39
11.8%
24.5%
Diabetic-Insulin
0.37
9.2%
23.4%
0.007
Single Stent
0.45
17.2%
Multiple Stents
0.33
11.5%
31.1%
Univariate analysis for TLR through 3 Year, done using the Cox regression model with the Hazard Ratio (HR) and pvalue should be the one testing the HR =1 to match the previous presentation.
0.5
1.0
1.5

29. Summary TAXUS II, IV, V, VI Meta-Analysis to 3-Years
Overall safety with the TAXUS stent to 3-years has been demonstrated
No increased risk of early stent thrombosis
Stent thrombosis rates at 3 years are comparable with control
Increased late ST between 6 mos and 2 yrs seen (8 TAXUS vs. 0 control) – but 0 stent thrombosis with TAXUS between 2 and 3 years (vs. 1 case with control)
Comparable rates of all cause death, cardiac death, and MI with TAXUS and control
Marked reduction in TLR with TAXUS compared to control for 3 years with no late catch-up apparent

30. Summary TAXUS II, IV, V, VI Meta-Analysis to 3-Years
Subgroups
Significant benefit in all patient groups stratified by vessel size, lesion length and diabetic status; increased absolute benefit in higher risk cohorts
Multiple stent group
Increase peri-procedural non-Q MI in TAXUS pts
3-year results demonstrate similar rates of cardiac death and MI, and a marked reduction in TLR and binary restenosis