Studying the roles of CABG and PCI using DES in the contemporary management of Left Main andor Three

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SYNTAX (SYNergy between PCI with TAXUS and
cardiac surgery)

• Studying the roles of CABG and PCI using DES in
  the contemporary management of Left Main and/or
  Three-Vessel Disease Patients

TAXUS Express Stent Isolated or in
conjunction with 1, 2, 3VD and
revascularization for all 3 vascular territories
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The safety and effectiveness of the TAXUS
Express2 Stent System have not been established
in the following patient populations patients
with vessel thrombus at the lesion site patients
with coronary artery lesions longer than 28 mm or
requiring more than one TAXUS stent lesions
located in the unprotected left main coronary
artery, or lesions located at a
bifurcation/trifurcation patients with moderate
or severe calcification in the lesion or a
chronic total occlusion or patients with
multi-vessel disease or patients with diabetes
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Patient Profiling

• Local Heart team (surgeon interventional
  cardiologist) will assess each patient in regards
  to
• Patients operative risk (EuroSCORE Parsonnet
  score)
• Coronary lesion complexity (Newly developed
  SYNTAX score)
• The goal of the SYNTAX score is to provide a tool
  to assist physicians in their revascularization
  strategies for patients with high risk lesions

Dominance
Sianos et al, EuroIntervention 20051219-227 Valg
imigli et al, Am J Cardiol 2007991072-1081 Serru
ys et al, EuroIntervention 20073450-459
BARI classification of coronary segments Leaman
score, Circ 198163285-299 Lesions
classification ACC/AHA , Circ 20011033019-3041
Bifurcation classification, CCI
200049274-283 CTO classification, J Am Coll
Cardiol 199730649-656
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SYNTAX Primary EndpointRandomized Trial

• The Primary Clinical Endpoint is the 12 Month
  Major Cardiovascular or Cerebrovascular Event
  Rate (MACCE )
• MACCE is defined as
• All cause Death
• Cerebrovascular Event (Stroke)
• Documented Myocardial Infarction
• Any Repeat Revascularization (PCI and/or CABG)
• All events CEC Adjudicated

ARC MACCE definition Circ 2007 1152344-2351
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SYNTAX Trial Design

23 US Sites
62 EU Sites
All Pts with de novo 3VD and/or LM disease
(N4,337)

• Treatment preference (9.4)
• Referring MD or pts. refused informed consent
  (7.0)
• Inclusion/exclusion (4.7)
• Withdrew before consent (4.3)
• Other (1.8)
• Medical treatment (1.2)

71 enrolled (N3,075)
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SYNTAX Trial Design

23 US Sites
62 EU Sites
TAXUS Express Stent
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SYNTAX Trial Design

23 US Sites
62 EU Sites
TAXUS Express Stent
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Patient Characteristics (l)Randomized Cohort
TAXUS Express Stent
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Patient Characteristics (lI)Randomized Cohort
TAXUS Express Stent
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Procedural CharacteristicsPCI Randomized Cohort
TAXUSN903
Patient-based
TAXUS Express Stent
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Procedural CharacteristicsCABG Randomized Cohort
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All-cause Death to 12 Months
P0.37
4.3
3.5
TAXUS Express Stent
Event Rate 1.5 SE
ITT population Fisher Exact Test
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Cerebrovascular Events to 12 Months
P0.003
2.2
0.6
TAXUS Express Stent
Event Rate 1.5 SE
ITT population Fisher Exact Test
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Myocardial Infarction to 12 Months
P0.11
4.8
3.2
TAXUS Express Stent
Event Rate 1.5 SE
ITT population Fisher Exact Test
15
Death/CVA/ MI to 12 Months
P0.98
7.6
7.7
TAXUS Express Stent
Event Rate 1.5 SE
ITT population Fisher Exact Test
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Symptomatic Graft Occlusion Stent Thrombosis at
12 Months
TAXUS (N903)
CABG (N897)
P0.89
Patients ()
3.3
3.4
N27
N28
CABG
TAXUS
TAXUS Express Stent
ITT population
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Repeat Revascularization to 12 Months
Plt0.0001
13.7
5.9
TAXUS Express Stent
Event Rate 1.5 SE
ITT population Fisher Exact Test
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MACCE to 12 Months
P0.0015
17.8
12.1
TAXUS Express Stent
Event Rate 1.5 SE
ITT population Fisher Exact Test
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Primary Endpoint12 Month MACCE Non-inferiority
Analysis
Pre-specified Margin 6.6
95 CI 8.3
5.5
0
5
10
15
20
Difference in MACCE
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Left Main Subgroup MACCE Rates at 12 Months
Patients ()
All LMN705
Comparisons for the LM and 3VD subgroups are
observational only and hypothesis generating
TAXUS Express Stent
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Left Main and Three Vessel Disease Subgroup
MACCE Rates at 12 Months
Patients ()
All LMN705
LM1VDN138
LM isolatedN91
LM2VDN218
LM3VD N258
3VD (All) N1095
Comparisons for the LM and 3VD subgroups are
observational only and hypothesis generating
TAXUS Express Stent
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Medically Treated Diabetes and Non-DiabeticAll-Ca
use Death/CVA/MI and MACCE at 12 Months
P0.0025
P0.96
P0.08
P0.97
MACCE
Death/CVA/MI
MACCE
Death/CVA/MI
Non-Diabetic N1348
Diabetes (Medical Treatment) N452
TAXUS Express Stent
ITT population
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Conclusions I

• The SYNTAX randomized trial is a unique
  comparison of the utility of contemporary CABG
  and PCI with drug-eluting TAXUS Express stents
  in the most challenging groups of patients, those
  with Left Main and/or Three Vessel coronary
  disease
• The trial attempted an all-comers strategy with
  the minimum of exclusion criteria
• The complexity of the patients recruited into the
  SYNTAX trial are unique in the field to date

Isolated or in conjunction with 1, 2, 3VD and
revascularization for all 3 vascular
territories
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Conclusions II

• Non-inferiority comparison was not met for the
  primary endpoint
• In the randomized SYNTAX cohort, there were
  comparable overall safety outcomes (Death, CVA,
  MI,) in CABG and PCI patients at 12 months (7.7
  vs. 7.6).
• There was a significantly higher rate of
  revascularization in the PCI group (13.7 vs. 5.9
  ), and a significantly higher rate of CVA in the
  CABG group (2.2 vs. 0.6).
• Overall MACCE in the PCI group was higher (17.8
  vs. 12.1) due to an excess of redo
  revascularization compared with CABG.
• Per protocol rates of symptomatic graft occlusion
  and stent thrombosis were similar.
• The goal of the SYNTAX score is provide a tool to
  assist physicians in their revascularization
  strategies for patients with high risk lesions

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TAXUS Express Stent System Abbreviated Statement