FDA Panel on Drug-eluting Stent Safety December 7 and 8th, 2006 Boston Scientific Presentation: Part I On-label Use of the TAXUS

1
FDA Panel on Drug-eluting Stent SafetyDecember 7
and 8th, 2006 Boston Scientific Presentation
Part IOn-label Use of the TAXUS Drug-eluting
Stent System

• Donald S. Baim, M.D.
• Executive Vice President
• Chief Medical and Scientific Officer
• Boston Scientific Corporation
• Glossary/Appendix At End Of Presentation

2
Donald S. Baim, MD
Faculty member since 1981 Professor of Medicine,
1994-2006
Founder and Chief
Interventional Cardiology Section 1981-2000
Senior Physician
Interventional Cardiologist 2000-2006
Co-founder (with Dr. Kuntz) Chief
Scientific Officer Harvard
Clinical Research Institute
Editor-in-Chief, (4th through 7th edition
2006) Grossmans Cardiac Catheterization,
Angiography and Intervention
3
Evolution of PCI The dominant coronary
revascularization since 1990
Over the last 30 years, percutaneous coronary
intervention (PCI) has undergone progressive
improvements in success, safety, and durability,
as serial new technologies have been launched.
While each innovations solved a serious prior
problem, it has sometimes introduced rare new
adverse events (e.g., in-stent restenosis, stent
thrombosis).
Current results of DES-PCI are the BEST they have
ever been
4
TAXUS SR Stent Randomized Clinical Data

• The TAXUS I, II-SR, IV, and V randomized trials
  compared the TAXUS Slow-Release (SR) Stent to
  Bare Metal Stent (BMS) controls in 2,797
  patients, median 4 year follow-up
• PROFOUND clinical benefit reduction in repeat
  revasc. (D 9.7, or 48 relative)
• Trends towards LESS Death (D -0.3 ) or Q-MI (D
  -0.1) through last follow-up
• This favorable risk benefit was seen in all
  studied sub-groups, with TLR reductions of
• Diabetics (n715) D 11.5, (46 relative), p
  lt 0.0001
• Small vessels (lt2.5mm) (n965) D 13.2, (48
  relative), p lt 0.0001
• Long Lesions gt 28 mm (n341) D 18.2, (58
  relative), p lt 0.0001
• Multiple Stents/vessel (n497) D 23.1, (64
  relative), p lt 0.0001
• Stent thrombosis rates were not statistically
  different from the BMS Control for either
  4 years cum. or
  Beyond 1 year (VLST)
• Per protocol 1.3 vs. 0.8, p0.24 D
  0.4, p0.057
• ARC 1o def.prob. 1.8 vs. 1.1, p0.17 D
  0.5, p0.081
• ARC Total 3.5 vs. 3.6, p0.84 D -
  0.1, p0.786
• Plavix use beyond 6 months with TAXUS showed a
  trend towards reduced Death or MI

The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients longer than 12 months or with diabetics,
in lesions longer than 28mm, coronary artery RVDs
lt2.5mm, for the treatment of multiple vessels, or
with implementation of multiple stents. Plavix
is a trademark of Sanofi-Aventis.
5
Agenda

• Background
• Stent Thrombosis ARC Definitions
• TAXUS Meta-Analysis All Patients
• TAXUS Meta-Analysis Subgroups
• Antiplatelet Usage
• Summary and Conclusions

6
A Brief History of Stent Thrombosis
Incomplete/delayed endothelial coverage with DES
Decreasing incidence of ST with BMS
0.7
Stent thrombosis with BMS decreased progressively
due to the use of high-pressure stent deployment
and 1 month of dual anti-platelet Rx (aspirin,
and ticlopidine or clopidogrel). SAT almost
always occurred within 1 month of implantation.
While the main benefit of DES (? in-stent tissue)
has decreased restenosis, the associated drugs or
polymers may interfere with rapid complete
endothelial coverage, at least in some patients
Delayed endothelialization of DES was
anticipated, as shown by longer (3 6 months)
anti-platelet therapy, but it may have
unmasked a new (but rare, 0.5) event Very
Late ST gt 1 year after implantation.
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months.
7
The TAXUS Express Stent Boston Scientific
Corporation
Drug
Polymer
Stent
paclitaxel
Paclitaxel
TransluteTM
Express Stent

• Binds tubulin
• Stabilizes microtubular deconstruction
• Suppresses migration and proliferation
  (cytostatic) at low concentrations

ABA triblock thermoplastic elastomer Styrene- b
isobutylene-b styrene biostable and biocompatible
provides controlled matrix release
Stainless steel Tandem Architecture Stent
Design Maverick Balloon Catheter Flexible,
deliverable

• Studied clinically in 2 different versions
• Slow-release (SR)
• commercialized version
• Moderate release (MR)
• roughly 3x released dose compared to SR
• -- never commercialized in any country

The TAXUS Express Moderate Release Stent is not
approved for sale and the safety and
effectiveness of this device have not been
established.
8
DES Trials and Follow-up
Currently, only TAXUS and Cypher stents have
enough patients with enough long-term follow-up
to accurately assess VLST and late clinical events
1 yr
2 yrs
3 yrs
5 yrs
4 yrs
TAXUS I (n61)
TAXUS II (n536)
3,500 patients ( 2,800 with SR) Median
follow-up 4 years
TAXUS IV (n1314)
TAXUS V (n1156)
TAXUS VI (n448)
RAVEL (n238)
SIRIUS (n1058)
1,800 patients Median follow-up 4 years
E-SIRIUS (n352)
C-SIRIUS (n100)
ENDEAVOR I (n100)
1,400 patients Median follow-up 2 years
ENDEAVOR II (n1200)
ENDEAVOR III (n436)
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months. Cypher is a
trademark of Cordis Corporation.
9
The TAXUS SR Stent Trials (N 2,797)Patients
randomized to Taxus SR vs BMS
Cohort 1 (SR)
Stent Platform
Indication expansion
Pivotal
Efficacy, dose-response
Safety and feasibility
Study Objective
1,156
1,314
266
61
n ITT patients
TVR Non-TVR
TVR Non-TVR
net volume obstruction (IVUS)
Safety and procedural success
1 endpoint
2 years
4 years
4 years
5 years
Long-term F/U available
2.25 -4.0
2.5 -3.75
3.0 -3.5
3.0 -3.5
RVD (mm)
Multiple overlap
Single
Single
Single
Lesion
10 -46
10 - 28
10 -12
12
Lesion length (mm)
2
2
1
1
Max. planned study stents per lesion/patient
RVDReference Vessel Diameter As per trial
inclusion/ exclusion criteria. NIRx is a
trademark of Medinol, Ltd., Jerusalem, Israel.
10
Methodology

• Pilot, pivotal and label extension randomized
  trials (IDE)
• Full monitoring and FDA audits of source data
• Independent Core Laboratories (angio, IVUS,
  EKG)
• Outside adjudication of all endpoints
• HCRI for ARC stent thrombosis adjudication
• Internal (Boston Scientific) data entry and
  analysis
• Independent review and analysis of all
  patient-level data
• Pocock Global Data and Safety Monitoring
  (October 2006)
• Cardiovascular Research Foundation (October
  2006)
• Serruys (pending)

11
Independent CRF patient-level meta-analysis
Freedom From (Protocol) Stent Thrombosis
TAXUS I, II, IV, V, VI-SRMR (n3,506)
RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n1,748)
0.57a
0.48b
0.40b
Time after Initial Procedure (years)
Time after Initial Procedure (years)

• Difference BMS Cypher
  b.
  Difference BMS Taxus

CRF analysis presented by Dr. Gregg Stone and Dr.
Martin Leon, TCT 2006. The safety and
effectiveness of the TAXUS Express2 Stent have
not been established in patients for longer than
12 months.
12
Agenda

• Background
• Stent Thrombosis ARC Definitions
• TAXUS Meta-Analysis All Patients
• TAXUS Meta-Analysis Subgroups
• Antiplatelet Usage
• Summary and Conclusions

13
ARC Definitions a large and needed step towards
clarity

• Definite/Confirmed
• Acute coronary syndrome AND either
• Angiographic confirmation of thrombus or
  occlusion OR
• Pathologic confirmation of acute thrombosis
• Probable
• Unexplained death within 30 days
• OR
• Target vessel MI, even without angiographic
  confirmation of thrombosis or other identified
  culprit lesion
• Possible
• Unexplained death after 30 days

Adapted from Dr. Don Cutlip, TCT 2006
14
ARC Definition (not a single definition, but a
set of definitions)
(specific, but not sensitive and may miss
adverse events)
(optimal sensitivity and specificity best
suited for examining any differential ST
mechanism)
(sensitive, but not specific and may dilute out
any true safety signal)
Also almost identical to the Protocol definition
used in the TAXUS trials
15
Possible Stent Thrombosis is Too Broad Death in
the TAXUS SR Stent Studies (N 2,797) reflect
mostly natural history, and not stent thrombosis
Constant mortality hazard of 1.8 per year after
1 year ( 25 unexplained) with TAXUS 1.71
/ year with BMS 1.87 / year
Possible ST gt 1 yr With TAXUS
0.36/year With control 0.53/year When all
patients have died, BMS Possible ST will
reach 25 !!
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months.
16
Inclusion of Post-TLR Stent Thrombosis is Too
BroadDifferential use of post-brachytherapy in
BMS arm obscures any mechanistic differenceIt is
preferable to censor post-TLR thrombosis, and
capture any missed events in ITT Death/ MI
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months.
17
ARC Definite/Probable Thrombosis
Inclusion of Prior TLR Events hinders (not helps)
out understanding of whether any DES increase the
Very Late Stent Thrombosis mechanism warrants
increased anti-platelet therapy duration !!
TLR Effect
Primary Thrombosis
BMS Post-TLR ST Very late 4 def Late 1 prob
TAXUS Post-TLR ST Very late 1 def
22
21
18
After 1 yr, 9 vs. 3 p0.081
After 1 yr, 10 vs. 7 p0.45
13
Very Late is gt 1 yr, Late is 1 yr. The safety
and effectiveness of the TAXUS Express Stent
have not been established in patients for longer
than 12 months.
18
TAXUS SR Stent has no significant increase in
stent thrombosis by any definition
Rate (No. ST)
3.6 (41) 3.5 (39) p0.84
20 vs 22 (- 0.1) Log-rank p 0.79
ARC ALL
1.8 (21) 1.1 (13) p0.17
9 vs 3 ( 0.5) Log-rank p 0.08
ARC Def/Prob 1o
1.3 (16) 0.8 (10) p0.24
6 vs 1 ( 0.4) Log-rank p 0.06
Protocol ST
Post-TLR Events Censored
19
Agenda

• Background
• Stent Thrombosis ARC Definitions
• TAXUS Meta-Analysis All Patients
• TAXUS Meta-Analysis Subgroups
• Antiplatelet Usage
• Summary and Conclusions

20
Overall TAXUS Analysis (N 2,797) ARC ST (Total
Including post-TLR)
TAXUS analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
21
Overall TAXUS Analysis (N 2,797)ARC ST
(Primary Censoring ST post-TLR)
TAXUS analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
22
But have we spent so much time thinking about the
hole,that we are forgetting about the doughnut?
Late stent thrombosis is just one of several
causes of late death and MI (along with natural
history and restenosis)
Q-wave MI
Death
Repeat procedures
23
Overall TAXUS Analysis (N 2,797)Death -
Alternative Endpoints
?
TAXUS analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
24
Overall TAXUS Stent Analysis (N 2,797) MI -
Alternative Endpoints
TAXUS analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
25
Overall TAXUS Stent Analysis (N 2,797)
Revascularization
TAXUS analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
26
Overall TAXUS Analysis (N 2,797) Major Events
Overview
XXX
TAXUS analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
27
Overall TAXUS Analysis (N 2,797) ANNUAL HAZARD
RATES
4-year Cumulative Rates (K-M estimate )

• 1-4 Years
• ( / patient-year)

0-1 Year ( / patient-year)
Event
Risk Difference
BMS
Taxus
Risk Difference
BMS
Taxus
Risk Difference
BMS
Taxus
p
?
p
?
p
?
0.78
0.65
0.89
-0.16
7.4
7.1
-0.3
1.87
1.71
0.08
1.90
1.97
All Death
0.64
0.88
0.60
-0.03
3.1
2.7
-0.4
0.60
0.57
-0.22
1.31
1.10
Cardiac Death
0.87
0.23
0.52
0.3
6.4
6.9
0.5
0.71
1.01
-0.51
4.76
4.24
All MI
0.83
0.57
0.28
-0.1
1.1
1.0
-0.07
0.25
0.18
0.30
0.37
0.66
QWMI
0.24
0.06
0.82
0.5
0.8
1.3
0.18
0.04
0.21
0.07
0.66
0.73
ST Protocol
0.17
0.08
0.67
0.22
1.1
1.8
0.7
0.11
0.32
0.15
0.73
0.88
Primary ARC ST Def/ Prob
lt0.0001
0.04
lt0.0001
-9.7
20.2
10.5
-0.77
2.34
1.57
-10.21
17.59
7.37
TLR
0.0004
0.01
0.01
-3.1
6.4
3.3
-0.57
1.04
0.47
-1.50
3.19
1.69
TVR-CABG
TAXUS analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs.
p-value from Log rank test of no difference in
the Kaplan-Meier curves between the groups. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
28
TAXUS Stent 4-Year Meta-Analysis reinforces the
positive benefit / risk profile
TAXUS I, II-SR, IV, V (N2,797)
Benefit
Risk
p0.24
p0.78
p0.87
p0.83
plt0.0001
p0.17
p0.86
20.2 n266
10.5 n133
8.3 n89
7.9 n86
7.4 n79
7.1 n75
6.9 n82
6.4 n80
4-Yr Cumulative Events ()
1.8 n21
1.1 n13
1.3 n16
1.1 n12
1.0 n13
0.8 n10
Primary ARC ST Def/Prob
Protocol ST
All Death
All MI
Q Wave MI
TLR
Death or Q Wave MI
TAXUS Stent 4-year meta-analysis includes TAXUS I
(5 yr), II-SR cohort I (4 yr), IV (4 yr), V (2
yr) (N2,797). Kaplan Meier estimate and p
values from log rank The safety and
effectiveness of the TAXUS Express Stent have
not been established in patients for longer than
12 months.
29
Restenosis is not Benign Any Death or MI from
the 6 additional Protocol-defined stent
thromboses with the TAXUS stent is
counter-balanced by an offsetting 142-pt
reduction in first TLR and TLR-related events
with a bare metal stent (N1,397)
with a TAXUS stent (N1,400)
260 TLRsa
118 TLRsb
10 STs
16 STs

• Exclude 6 TLR due to ST
• b.Exclude 13 TLR due to ST and 2 TLR lt 30days.

30
Agenda

• Background
• Stent Thrombosis ARC Definitions
• TAXUS Meta-Analysis All Patients
• TAXUS Meta-Analysis Subgroups
• Patient groups that traditionally have higher
  event rates
• Diabetics
• Small vessels (lt2.5 mm)
• Long lesions (gt28 mm)
• Multiple stents in single vessels
• Antiplatelet Therapy Usage
• Summary and Conclusions

31
TAXUS Subgroup Analysis Diabetics (N 715)
TLR
RD -11.5 -18.0, -5.0 p lt0.0001
24.9 (81)
13.4 (40)
Diabetic analysis includes TAXUS I (5 yr), II-SR
cohort I (4 yr), IV (4 yr), V (2 yr) RCTs. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months or with diabetes.
32
TAXUS Subgroup AnalysisSmall Vessels RVD lt2.5mm
Visual (N 965)
Small vessel analysis includes TAXUS I (5 yr),
II-SR cohort I (4 yr), IV (4 yr), V (2 yr) RCTs.
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months or with RVD
2.5mm.
33
TAXUS Subgroup Analysis Long Lesions gt28mm
Visual (N 341)
TLR
RD -18.2 -28.4, -8.0 p lt 0.0001
31.3 (47)
13.1 (20)
Small vessel analysis includes TAXUS I (5 yr),
II-SR cohort I (4 yr), IV (4 yr), V (2 yr) RCTs.
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months or with
lesions longer than 28mm.
34
TAXUS Subgroup Analysis Multiple Stents in
Single Vessels (N 497)
Small vessel analysis includes TAXUS I (5 yr),
II-SR cohort I (4 yr), IV (4 yr), V (2 yr) RCTs.
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months or with
implementation of multiple stents.
35
Summary TAXUS Stent Subgroup Difference Signals
4 year cumulative
1 year 4 year cum
Event
Lesion gt 28 N 341
RVD lt 2.5mm N 965
Diabetics N715
Multiple Stents N497
Overall N2,797
Overall N 2,797
-3.0 p0.28
0.6 p0.63
-1.5 p0.78
-4.0 p0.16
-0.3 p0.78
0.08 p0.89
All Death
3.0 p0.44
-0.4 p0.95
1.0 p0.64
2.2 p0.53
-0.4 p0.64
-0.22 p0.60
Cardiac Death
9.5 p0.01
-0.6 p0.28
-0.2 p0.57
-1.9 P0.53
0.5 p0.87
-0.51 p0.52
All MI
1.1 p0.35
-0.4 p0.44
-0.8 p0.34
-2.4 p0.37
-0.1 p0.83
0.30 p0.28
QWMI
0.00 p0.96
0.1 p0.79
-0.2 p0.50
0.4 p0.70
0.5 p0.24
0.07 p0.82
ST Protocol
-0.3 p0.93
0.1 p0.83
0.8 p0.96
0.4 p0.76
0.7 p0.17
0.15 p0.67
Primary ARC ST Def/ Prob
-18.2 plt0.0001
-13.2 plt0.0001
-11.5 plt0.0001
-23.1 plt0.0001
-9.7 plt0.0001
-10.21 plt0.0001
TLR
-6.9 p0.02
-5.1 p0.0006
-2.6 p0.13
-5.3 P0.08
-3.1 p0.0004
-1.50 p0.01
TVR-CABG
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients longer than 12 months or with diabetics,
in lesions longer than 28mm, coronary artery RVDs
lt2.5mm, or with implementation of multiple
stents.
36
Agenda

• Background
• Stent Thrombosis ARC Definitions
• TAXUS Meta-Analysis All Patients
• TAXUS Meta-Analysis Subgroups
• Antiplatelet Usage
• Summary and Conclusions

37
Long-Term-Thienopyridine Intake in TAXUS
Clinical Trial Program

• Limitations
• No formal medication log
• Incomplete data collection between trials at
  various time points

DFU compliance
Physician Discretion
93.6
83.2
53.9
Patients on Clopidogrel or Ticlopidine
39.8
31.2
18.2
15.1
2,312/2,470
272/327
1,332/2,470
1,088/2,736
771/2,470
239/1,314
198/1,314
The safety and effectiveness of the TAXUS
Express Stent have not been established in
patients for longer than 12 months.
38
Death or MI During Follow-up to 2 Years
Post-ProcedureAccording to Plavix /Ticlid
Usage at 12 Months
Taxus- P/T Interaction p value 0.0943
Adjusted Cox regression model, additionally
adjusted for patient baseline and lesion
characteristics. Medication data available in
TAXUS II, IV, and V only. Medication data
available in TAXUS IV, V only. Plavix and
Ticlid are trademarks of Sanofi-Aventis. The
safety and effectiveness of the TAXUS Express
Stent have not been established in patients for
longer than 12 months.
39
Death or MI During Follow-up to 4 Years
Post-ProcedureAccording to Plavix /Ticlid
Usage at 12 Months
Medication data available in TAXUS II, IV, V.
Medication data available in TAXUS VI, V only.
Medication data available in TAXUS IV only.
Plavix and Ticlid are trademarks of
Sanofi-Aventis. The safety and effectiveness of
the TAXUS Express Stent have not been
established in patients for longer than 12 months.
40
Summary - On-label uses of the TAXUS SR Stent
System

• The TAXUS I, II-SR, IV, and V randomized trials
  compared the TAXUS Slow-Release (SR) Stent to
  Bare Metal Stent (BMS) controls in 2,797
  patients, median 4 year follow-up
• PROFOUND clinical benefit reduction in repeat
  revasc. (D 9.7, or 48 relative)
• Trends towards LESS Death (D -0.3 ) or Q-MI (D
  -0.1) through last follow-up
• This favorable risk benefit was seen in all
  studied sub-groups, with TLR reductions of
• Diabetics (n715) D 11.5, (46 relative), p
  lt 0.0001
• Small vessels (lt2.5mm) (n965) D 13.2, (48
  relative), p lt 0.0001
• Long Lesions gt 28 mm (n341) D 18.2, (58
  relative), p lt 0.0001
• Multiple Stents/vessel (n497) D 23.1, (64
  relative), p lt 0.0001
• Stent thrombosis rates were not statistically
  different from the BMS Control for either
  4 years cum. or
  Beyond 1 year (VLST)
• Per protocol 1.3 vs. 0.8, p0.24 D
  0.4, p0.057
• ARC 1o def.prob. 1.8 vs. 1.1, p0.17 D
  0.5, p0.081
• ARC Total 3.5 vs. 3.6, p0.84 D -
  0.1, p0.786
• Plavix use beyond 6 months with TAXUS showed a
  trend towards reduced Death or MI

Plavix is a trademark of Sanofi-Aventis.
41
Appendix Source References
SIRTAX Windecker S, Remondino A, Eberli FR, et
al. Sirolimus-eluting and paclitaxel-eluting
stents for coronary revascularization. N Engl J
Med. 2005 Aug18353(7)653662. SIRIUS Moses JW,
Leon MB, Popma JJ, et al SIRIUS Investigators.
Sirolimus-eluting stents versus standard stents
in patients with stenosis in a native coronary
artery. N Engl J Med. 2003349(14)13151323. REAL
ITY Morice MC, Colombo A, Meier A, et al.
Sirolimus- vs. paclitaxel-eluting stents in de
novo coronary artery lesions. The REALITY Trial
A randomized controlled trial. JAMA
2006295895904. ISAR-Diabetes Dibra A,
Kastrati A, Mehilli J, et al. Paclitaxel-eluting
or sirolimus-eluting stents to prevent restenosis
in diabetic patients. N Engl J Med. 2005 Aug
18353(7)663670. S.T.E.N.T. Simonton C, Brodie
B, Cheek B, et al. Late clinical outcomes of
paclitaxel and sirolimus-eluting coronary stents
in diabetic patients Results from the Strategic
Transcatheter Evaluation of New Therapies (STENT)
Group. American College of Cardiology/i2 Summit
2006 Annual Scientific Meeting, Atlanta,
Georgia TAXi Goy JJ, Stauffer JC, Siegenthaler
M, et al. A prospective randomized comparison
between paclitaxel and sirolimus stents in the
real world of interventional cardiology the TAXI
trial. J Am Coll Cardiol. 2005 Jan
1845308-11. SOLACI Sousa A, Abizaid A, Hayashi
EB, et al. Outcomes of percutaneous interventions
in diabetics treated with drug-eluting stents or
bare metal stents. SOLACI registry results.
Transcatheter Cardiovascular Therapeutics
2005. ARRIVE Lasala J. Snapshot of DES use and
outcomes in the US The ARRIVE program.
Cardiovascular research foundation symposium.
American College of Cardiology/i2 Summit 2006
Annual Scientific Meeting, Atlanta,
Georgia. TC-WYRE Kandzari D. TCT 2006 REAL
Saia. JACC 2006481312-8 LONG-DES-II Park SJ.
TCT 2006 DEScover Williams, D. Published online
Circulation 10/23/2006 Prairie Heart Institute
Mishkel G. TCT 2006 Centro Cuore Columbus / MILAN
II Cosgrave J., TCT 2006 SORT-OUT II Galloe A.,
TCT 200621. Research/T-search Long Lesions Aoki,
et al, Am Heart J 2005 150 994-9 RESEARCH/
T-SEARCH Andrew T.L. Ong et al, Comparison of
Short and Long Term Outcomes of Sirolimus vs.
Paclitaxel Stents in 293 consecutive patients
with diabetes. AJC 2005 96 358-362 Milan
Registry Diabetic Data presented by Iakovou at
TCT 2005 TAXUS IV Stone GW, Ellis SG, Cox DA, et
al, for the TAXUS IV Investigators. A
polymer-based, paclitaxel-eluting stent in
patients with coronary artery disease. N Engl J
Med 2004350221231. TAXUS V Stone GW, JAMA
20052941215-1223 TAXUS V ISR Stone GW, Ellis
SG, O'Shaughnessy CD, et al TAXUS V ISR
Investigators. Paclitaxel-eluting stents vs
vascular brachytherapy for in-stent restenosis
within bare-metal stents the TAXUS V ISR
randomized trial. JAMA. 2006295(11)12531263. TA
XUS Meta-analysis presented by Gregg Stone at ACC
2005 / Cypher Integrated Analysis presented by
Wijns at ACC 2005
42
Appendix Source References
TAXUS I trial TAXUS Stent is the
Paclitaxel-eluting NIR Stent control is the
NIR Stent. NIR is a trademark of Medinol Ltd.
Jerusalem - TAXUS NIR (or NIRx) Stent is an
investigational device, not for sale in the
European Economic Area (EEA) TAXUS II trial
TAXUS Stent is the Paclitaxel-eluting NIR
Stent control is the NIR Stent. NIR is a
trademark of Medinol Ltd. Jerusalem - TAXUS NIR
(or NIRx) Stent is an investigational device, not
for sale in the European Economic Area
(EEA) TAXUS IV and TAXUS VI trials TAXUS Stent
is the TAXUS Express Stent control is the
Express Stent. TAXUS Express Stent is an
investigational device, not for sale in the
European Economic Area (EEA) TAXUS V trial
TAXUS Stent is the TAXUS Express² Stent
control is the Express² Stent Cypher Integrated
Analysis is a trial sponsored by JJ-Cordis
Corp. Endeavor I, II and III are trials
sponsored by Medtronic, Corp. RAVEL, E- SIRIUS,
C-SIRIUS are trials sponsored by JJ-Cordis Corp.
S.T.E.N.T IDDM is an independent registry MILAN
and MILAN II are independent registries TC WYRE
is an independent registry Prairie Heart is an
independent registry Kaiser Permanente is an
independent registry SOLACI is an independent
registry Research/T-Search is an independent
registry ISAR Diabetes is an independent
registry TAXUS Stent meta-analysis TAXUS II (4
yr) , IV (4 yr), V (2yr), VI (3 yr) studies
TAXUS Stents include the Paclitaxel-Eluting NIR
Stent (NIR is a trademark of Medinol, Ltd,
Jerusalem) in the TAXUS II study, the TAXUS
Express Stent in the TAXUS IV and VI studies and
the TAXUS Express2 Stent in the TAXUS V study.
BMS Control includes the NIR in the TAXUS II
study, Express Stent in the TAXUS IV and VI
studies and Express2 Stent in the TAXUS V study.
Paclitaxel-Eluting NIR Stent and TAXUS Express
Stent are investigational devices only. All other
cited studies are owned by their respective
Sponsors

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