Stent TAXUS Superioridad en Diabticos

1
Stent TAXUS Superioridad en Diabéticos
Glossary at end of presentation This material is
not intended for use in the United States
Vs BMS TAXUS 4 year meta-analysis (All
Diabetics) presented by Dr. Stone, TCT 2006.
TAXUS Stent meta-analysis (all diabetics) TAXUS
II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr)
(N3445). 1. Colombo et al. Circulation.
2003108788 2. Stone et al. N Engl Med.
2004350221 3. Stone et al. JAMA.
20052941215 4. Dawkins et al. Circulation.
20051123306. Vs Cypher Stent TC WYRE registry
data presented by Dr. Kandzari and Dr. ONeill at
TCT 2006. Kaiser Permanente registry data
presented by Dr. Brar at TCT 2006. Prairie Heart
Institute registry data presented by Dr. Mishkel
et al. TCT 2006. T-Search/Research registry
presented by Dr. Daemen at AHA 2006. Cypher is a
registered trademark of JJ/Cordis Corp.
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• TAXUS es superior en pacientes diabéticos

TAXUS es más eficaz en diabéticos TAXUS es
seguro incluso en los pacientes diabéticos más
complejos
Vs BMS TAXUS 4 year meta-analysis (All
Diabetics) presented by Dr. Stone, TCT 2006.
TAXUS Stent meta-analysis (all diabetics) TAXUS
II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr)
(N3445). 1. Colombo et al. Circulation.
2003108788 2. Stone et al. N Engl Med.
2004350221 3. Stone et al. JAMA.
20052941215 4. Dawkins et al. Circulation.
20051123306. Vs Cypher Stent TC WYRE registry
data presented by Dr. Kandzari and Dr. ONeill at
TCT 2006. Kaiser Permanente registry data
presented by Dr. Brar at TCT 2006. Prairie Heart
Institute registry data presented by Dr. Mishkel
et al. TCT 2006. T-Search/Research registry
presented by Dr. Daemen at AHA 2006. Cypher is a
registered trademark of JJ/Cordis Corp. Complex
diabetic patients insulin-treated and/or complex
lesions.
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3

• TAXUS es superior en pacientes diabéticos

TAXUS es más eficaz en diabéticos TAXUS es
seguro incluso en los pacientes diabéticos más
complejos
Vs BMS TAXUS 4 year meta-analysis (All
Diabetics) presented by Dr. Stone, TCT 2006.
TAXUS Stent meta-analysis (all diabetics) TAXUS
II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr)
(N3445). 1. Colombo et al. Circulation.
2003108788 2. Stone et al. N Engl Med.
2004350221 3. Stone et al. JAMA.
20052941215 4. Dawkins et al. Circulation.
20051123306. Vs Cypher Stent TC WYRE registry
data presented by Dr. Kandzari and Dr. ONeill at
TCT 2006. Kaiser Permanente registry data
presented by Dr. Brar at TCT 2006. Prairie Heart
Institute registry data presented by Dr. Mishkel
et al. TCT 2006. T-Search/Research registry
presented by Dr. Daemen at AHA 2006. Cypher is a
registered trademark of JJ/Cordis Corp. Complex
diabetic patients insulin-treated and/or complex
lesions.
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Stent TAXUS Reducción TLR estadísticamente
significativa en pacientes diabéticos
insulino-dependientes

CypherTM Stent Integrated Analysis
TAXUS Stent Meta-Analysis

Endeavor TM Stent ENDEAVOR II Study
9-Month TLR
9-Month TLR
9-Month TLR
p0.46
p0.0063
p1.00
19.4
66
16.9
13.6
11.5
10.1
5.8
N per arm not available
N70 total
N69
N62
N120
N136
No Significant Difference
No Benefit in Diabetics
TAXUS Stent Clinically Superior
TAXUS Stent
Endeavor Stent
Cypher Stent
BMS Controls
Cypheris a trademark of JJ/Cordis Corp.
Endeavor is a trademark of Medtronic Corp.
ENDEAVOR II study data published in Circulation.
2006114798806. Trials included in CypherTM
Integrated Analysis RAVEL, SIRIUS, E SIRUS and C
SIRIUS all studies sponsored by JJ-Cordis
Results published on TCTMD.com, Oct 17, 2005
TAXUS 4 year meta-analysis, presented by Dr.
Baim, TCT 2006.
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Datos de eficacia tendencia a favor del Stent
TAXUS en Pacientes Diabéticos
REALITY study
SOLACI registry
MILAN registry
12-Month TLR
12-Month TVR
9-Month TLR
pn.s.
pn.s.
p n.s.
New Data
18.4
15.9
8.1
5.8
5.2
4.1
N192
N186
N325
N420
N151
N228
Trend favors TAXUS Stent
Trend favors TAXUS Stent
Trend favors TAXUS Stent
TAXUS Stent
Cypher Stent
SOLACI data presented by Dr. Sousa, TCT 2005,
SOLACI is an independent registry. MILAN
Experience data published by Dr. Cosgrave in Am J
Cardiol 2005961663. MILAN Experience is an
independent registry. REALITY diabetic data
presented by Dr. Windecker at TCT 06. REALITY is
a study sponsored by JJ/ Cordis Corp. CypherTM
Stent is a registered trademark of JJ/ Cordis
Corp.
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Ultimos datos confirman que el Stent TAXUS es
Superior en Diabéticos
TCT 2006
TCT 2006
AHA 2006
T-SEARCH/RESEARCH Registry
TC WYRE Registry
Kaiser Permanente Registry
New Data
12-Month TVR
12-Month Death, MI,TVR
24-Month TLR
p0.004
p0.004
p0.02
60
67
56
13.2
9.0
8.5
5.3
4.0
2.8
N289
N247
N227
N272
N252
N206
TAXUS Stent Clinically Superior
TAXUS Stent Clinically Superior
TAXUS Stent Clinically Superior
TAXUS Stent
Cypher Stent
TC WYRE registry data presented by Dr. Kandzari
and Dr. ONeill at TCT 2006. Kaiser Permanente
registry data presented by Dr. Brar at TCT 2006.
Prairie Heart Institute registry data presented
by Dr. Mishkel et al. TCT 2006. T-Search/Research
registry presented by Dr. Daemen at AHA 2006.
Cypher is a registered trademark of JJ/ Cordis
Corp. Log-Rank p-value.
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Nuevos datos confirman que TAXUS es Superior
frente a Cypher en Diabéticos Insulino-dependient
es
CRT 2007
TC WYRE Registry
12-Month TVR
Insulin-treated Diabetics
New Data
p0.007
10.7
90
1.1
N84
N93
TAXUS Stent Clinically Superior
TAXUS Stent
Cypher Stent
TC WYRE registry data presented at CRT 2006 and
sponsored by Boston Scientific. Cypher is a
registered trademark of JJ/ Cordis Corp.
8
TAXUS muestra superioridad vs Cypher en
Diabéticos

CYPHER INTEGRATED ANALYSIS AND TAXUS
META-ANALYSIS (IDDM).Pooling of data
performed by Boston Scientific.Data points
represent similar lesion types from the two
referenced trials, but are not head to head
trials.
STENT diabetics, SOLACI, TC-WYRE, PRAIRIE
HEART are TVR
Cypher is a registered trademark of JJ/ Cordis
Corp. Milan Registry presented by Dr. Colombo at
ACC 2005 STENT Registry presented by Dr.
Simonton at ACC 2006 ISAR Diabetes study
published Dibra. NEJM 2005353663-70 SOLACI
Registry presented by Dr. Sousa at TCT 2005
T-SEARCH RESEARCH Registry published Daemen at,
et al. Euro Heart Journal 20072826-32. Diabetes
I, II presented by Dr. Sabate at PCR 2005.
Cypher Stent integrated analysis presented by
Dr. Stone at TCT 2006. TAXUS meta-analysis
presented by Dr. Stone at TCT 2006 . TC-WYRE
Registry presented by Dr. Kandzari at TCT 2006.
Prairie Heart Registry e-poster presented by Dr.
Mishkel at TCT 2006. MILAN II Registry presented
by Dr. Cosgrove at TCT 2006. REALITY diabetic
data presented by Dr. Windecker at TCT 06.
SIRTAX Diabetics presented by Dr. Windecker at
TCT 06, C vs T REWARD diabetics presented by
Dr. Waksman at ACC 06.
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Datos de Registros del Mundo Real refuerzan
los buenos resultados de TAXUS en los Pacientes
Diabéticos
WISDOM
Milestone II
ARRIVE I
ARRIVE II
OLYMPIA Phase I
6-Month TLR
1.1
Diabetics N261
TAXUS Express2 Stent system was used in WISDOM,
MILESTONEII, ARRIVE III registries, TAXUS
Liberté Stent system was used in the OLYMPIA
registry, WISDOM registry presented by Dr.
Russell, TCT 2004 sponsored by Boston Scientific
Corp., MILESTONE II registry presented by Dr.
Niemela, PCR 2005, sponsored by Boston Scientific
Corp. ARRIVE I registry presented by Dr. Lasala,
TCT 2005 sponsored by Boston Scientific Corp.,
ARRIVE II registry presented by Dr. Lasala, ACC
2006 sponsored by Boston Scientific Corp.,
OLYMPIA registry presented by Dr. Calderon,
SOLACI 2006 sponsored by Boston Scientific Corp.
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• TAXUS es superior en pacientes diabéticos

TAXUS es más eficaz en diabéticos TAXUS es
seguro incluso en los pacientes diabéticos más
complejos
Vs BMS TAXUS 4 year meta-analysis (All
Diabetics) presented by Dr. Stone, TCT 2006.
TAXUS Stent meta-analysis (all diabetics) TAXUS
II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr)
(N3445). 1. Colombo et al. Circulation.
2003108788 2. Stone et al. N Engl Med.
2004350221 3. Stone et al. JAMA.
20052941215 4. Dawkins et al. Circulation.
20051123306. Vs Cypher Stent TC WYRE registry
data presented by Dr. Kandzari and Dr. ONeill at
TCT 2006. Kaiser Permanente registry data
presented by Dr. Brar at TCT 2006. Prairie Heart
Institute registry data presented by Dr. Mishkel
et al. TCT 2006. T-Search/Research registry
presented by Dr. Daemen at AHA 2006. Cypher is a
registered trademark of JJ/Cordis Corp. Complex
diabetic patients insulin-treated and/ or complex
lesions.
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TAXUS Significativa reducción de TLR y tan
seguro como el BMS en diabéticos
TAXUS 4 yr meta-analysis All Diabetics TAXUS II1
(4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr) studies
(N814)
p0.58
p0.75
p0.18
p0.31
p0.80
plt0.0001
25.5
Events ()
? 3.0
13.1
12.6
11.0
9.6
9.1
4.6
3.8
1.7
1.2
1.4
0.5
Stent Thrombosis
All Death
CardiacDeath
Death or QWMI
TLR
QWMI
TAXUS Stent (N399)
Bare Metal Stent (N415)
TAXUS 4 year meta-analysis, presented by Dr.
Baim, TCT 2006. 1. Colombo et al. Circulation.
2003108788 2. Stone et al. N Engl Med.
2004350221 3. Stone et al. JAMA.
20052941215 4. Dawkins et al. Circulation.
20051123306.
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TAXUS Supervivencia libre de eventos a 4
añosSubgrupo pacientes Diabéticos
TAXUS Supervivencia Libre de Eventos a 4 años en
el subgrupo de Diabéticos
No Statistical Difference
P n.s.
Cumulative Event-Free Survival ()
Cumulative Event-Free Survival ()
P 0.58
Years
Years
TAXUS 4 year meta-analysis (All Diabetics)
presented by Dr. Stone, TCT 2006. TAXUS Stent
meta-analysis (all diabetics) TAXUS II1 (4 yr) ,
IV2 (4 yr), V3 (2yr), VI4 (3 yr) (N3445). 1.
Colombo et al. Circulation. 2003108788 2.
Stone et al. N Engl Med. 2004350221 3. Stone
et al. JAMA. 20052941215 4. Dawkins et al.
Circulation. 20051123306. n.s. not significant
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Cypher Supervivencia libre de eventos a 4
años Subgrupo Pacientes Diabéticos
Total population N1748
Diabetic patients N428
100
100
95.6
94.8
95
95
P0.194
P0.004
93.3
? 7.8
Cumulative Event-Free Survival ()
Cumulative Event-Free Survival ()
90
90
87.8
85
85
80
80
0
1
2
3
4
0
1
2
3
4
Years
Years
Cypher Stent
BMS control
Adapted from Spaulding et al. Spaulding et al. N
Eng J Med. 2007356989-97. Trials included in
Cypher Pooled Analysis RAVEL, SIRIUS, E SIRUS
and C SIRIUS all studies sponsored by JJ-Cordis.
Cypher is a trademark of JJ/ Cordis Corp. Log
rank p-value
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La Diferencia de Mortalidad en Diabéticos es
debida en primer lugar a Muerte Cardiaca
RAVEL, SIRIUS, E-SIRIUS and C-SIRIUS
Diabetic patients N428
Sirolimus
BMS Control
100
95.6
N233
N195
95
All Death
9 (3.9)
23 (11.8)
P0.004
? 7.8
Cumulative Event-Free Survival ()
90
14 (7.2)
5 (2.1)
Cardiac
87.8
4 (1.7)
9 (4.6)
Non-Cardiac
85
80
0
1
2
3
4
Years
Cypher Stent
BMS control
Adapted from Spaulding et al. Spaulding et al. N
Eng J Med. 2007356989-97. Trials included in
Cypher Pooled Analysis RAVEL, SIRIUS, E SIRUS
and C SIRIUS all studies sponsored by JJ-Cordis.
Cypher is a trademark of JJ/ Cordis Corp. Log
rank p-value. The control stent used for the
Cypher stent studies was the BX Velocity. BX
Velocity is a registered trademark of JJ/Cordis
Corp. Log rank p-value
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TAXUS presenta ratios de supervivencia similares
al BMS en Pacientes Diabéticos, a diferencia de
CYPHER
TAXUS Stent Analysis
Cypher Stent Analysis
Diabetic Patients N814
Diabetic Patients N428
100
100
95.6
95
95
90.9
P0.004
? 7.8
P 0.58
Cumulative Event-Free Survival ()
Cumulative Event-Free Survival ()
90
90
89.0
87.8
85
85
80
80
0
1
2
3
4
0
1
2
3
4
Years
Years
TAXUS Stent
BMS Control
Adapted from Spaulding et al. Spaulding et al. N
Eng J Med. 2007356989-97. Trials included in
Cypher Pooled Analysis RAVEL, SIRIUS, E SIRUS
and C SIRIUS all studies sponsored by JJ-Cordis.
Cypher is a trademark of JJ/ Cordis Corp. Log
rank p-value. TAXUS 4 year meta-analysis (All
Diabetics) presented by Dr. Stone, TCT 2006.
TAXUS Stent meta-analysis (all diabetics) TAXUS
II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr)
(N3445). 1. Colombo et al. Circulation.
2003108788 2. Stone et al. N Engl Med.
2004350221 3. Stone et al. JAMA.
20052941215 4. Dawkins et al. Circulation.
20051123306. n.s. not significant
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TAXUS Ratios de Mortalidad inferiores en
Pacientes Diabéticos
S.T.E.N.T. RegistryInsulin-Treated
Diabetics 9-months
Prairie Heart Institute Registry All
Diabetics 9-months
MILAN II RegistryAll Diabetics 12-months
p0.07
p0.005
p0.32
58
Mortality Rate ()
N263
N235
N147
N113
N928
N201
Trend favors TAXUS Stent
Trend favors TAXUS Stent
TAXUS Stent Clinically Superior
TAXUS Stent
Cypher Stent
S.T.E.N.T. Registry presented at ACC 2006 by Dr.
Simonton. Prairie Heart Institute study
presented by Dr. Mishkel et al. TCT 2006. Centro
Cuore Columbus (Milan II) data presented by Dr
Cosgrave at TCT 2006. Cypher is a registered
trademark of JJ/ Cordis Corp.
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TAXUS es tan seguro como el BMS aún siendo
utilizado en las lesiones más complejas
Mortality Data
MI Data
P 0.048
Incidence Rate ()
P 0.007
All Mortality (2 years)
Late (gt 1 yr) Mortality
2-year MI rate
TSEASRCH/RESEARCH Data presented by Joost Daemen
European Society of Cardiology, Nov. 2006. No
p-values other than the ones indicated were
significant. P-values were not reported for PES
vs. BMS or SES vs. BMS for Late (gt 1 yr.)
mortality. P-values were not reported for PES vs.
BMS or SES vs. PES for MI. In the
T-SEARCH/RESEARCH Diabetic registry, patients who
received the TAXUS Stent had more type C lesions,
higher incidence of multivessel treatment, higher
number of stented vessels, longer stented length,
and more CTOs. The TAXUSTM Express2 Stent is
contraindicated for use in patients with total
occlusion of target vessel.
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• TAXUS es superior en pacientes diabéticos

TAXUS es más eficaz en diabéticos TAXUS es
seguro incluso en los pacientes diabéticos más
complejos
Vs BMS TAXUS 4 year meta-analysis (All
Diabetics) presented by Dr. Stone, TCT 2006.
TAXUS Stent meta-analysis (all diabetics) TAXUS
II1 (4 yr) , IV2 (4 yr), V3 (2yr), VI4 (3 yr)
(N3445). 1. Colombo et al. Circulation.
2003108788 2. Stone et al. N Engl Med.
2004350221 3. Stone et al. JAMA.
20052941215 4. Dawkins et al. Circulation.
20051123306. Vs Cypher Stent TC WYRE registry
data presented by Dr. Kandzari and Dr. ONeill at
TCT 2006. Kaiser Permanente registry data
presented by Dr. Brar at TCT 2006. Prairie Heart
Institute registry data presented by Dr. Mishkel
et al. TCT 2006. T-Search/Research registry
presented by Dr. Daemen at AHA 2006. Cypher is a
registered trademark of JJ/Cordis Corp. Complex
diabetic patients insulin-treated and/or complex
lesions.
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Glossary

• Clinical Trials and Registries
• Cypher Integrated Analysis includes SIRIUS,
  E-SIRIUS, C-SIRIUS and RAVEL (studies sponsored
  by JJ Cordis Corp.)
• Endeavor II is a study sponsored by Medtronic,
  Corp.
• S.T.E.N.T is an independent registry
• MILAN and MILAN II are independent registries
• REALITY is a trial sponsored JJ / Cordis Corp.
• SIRTAX is an independent trial
• TC WYRE is a registry sponsored by Boston
  Scientific
• Prairie Heart is an independent registry
• Kaiser Permanente is an independent registry
• SOLACI is an independent registry
• Research/T-Search is an independent registry
• Diabetes I and II are independent registries
• ISAR Diabetes is an independent registry
• Cypher Diabetic Pooled Analysis Spaulding et al.
  N Eng J Med. 2007356989-97
• 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.

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