Presentation Syntax Score TCT 2008 PDF

The SYNTAX Score
A new angiographic tool to grade the complexity of coronary artery disease
On behalf of the SYNTAX investigators
Patrick W. Serruys, MD, PhD
Conflicts of Interest
None
Study and Presentation Supported by Boston Scientific Corporation
SYNTAX Score Serruys
TCT 14 October 2008 Slide 2
The SYNTAX Trial

Provides evidence-based medicine comparing modern CABG vs PCI in patients with 3VD and/or LM disease Patient and lesion complexity not included in prior studies Determines which patients are amendable for both revascularization methods or eligible for only 1 treatment approach (CABG or PCI) Evaluates a new tool (SYNTAX Score) to effectively characterize coronary vasculature and predict outcomes
The Ultimate Goal of the SYNTAX Score

Create a prospective angiographic tool to grade complexity of coronary disease
A semi-quantitative, visual score will help interventional cardiologists and surgeons be aware of the anatomical complexity to anticipate procedural difficulties and eventually predict outcomes
Obtain evidence-based guidelines for selecting revascularization technique (surgery or PCI) The SYNTAX Score will be retroactively weighted based on MACCE at 1 and 5 years to optimize its prognostic value
SYNTAX Score Serruys TCT 14 October 2008 Slide 4
SYNTAX Score Methodology

Prior to treatment, at the local Heart Team conference (surgeon and interventional cardiologist), the SYNTAX Score was calculated for all significant lesions in vessels 1.5mm In addition, the SYNTAX Score was calculated from the diagnostic angiogram by a core laboratory (Cardialysis) The core laboratory also compared inter-observer variability
Derivation of the SYNTAX Score

Incorporates information collected through: Coronary tree segments based on the classification proposed by the AHA and modified for the ARTS study (Circulation 1975; 51:31-3 & Semin Interv Cardiol 1999;
4:209-19)
Modified Leaman score (Circulation 1981; 63: 285-292) ACC/AHA lesions classification system (Circulation
2001;103:3019-3041)
Cardiol,1997;30:649-56)
Combination of the Duke and ICPS classification of Bifurcation (Cathet Cardiovasc Intervent 2000; 49:274-283) Total occlusion classification (J Am Coll Consultation of experts
Components of the SYNTAX Score

Number & Dominance location of lesions Calcification Left Main
Thrombus
SYNTAX score
3 Vessel Total Occlusion
Bifurcation Tortuosity
EuroInterv 2005;1:219-227
SYNTAX Score: How It Works (I)

The SYNTAX score is lesion based
A separate number calculated per lesion Summed to generate the total SYNTAX score
Questions 1-3: determine dominance, total # of

lesions and vessel segments/lesion characteristics; are repeated for each lesion The SYNTAX score is calculated after answering a set of sequential, interactive self-guided questions
Questions 4-12: detail adverse lesion
SYNTAX Score: How It Works (II)
www.syntaxscore.com Site under construction
Reduction in Vessel Diameter

The SYNTAX Score considers only significant or occlusive lesions
Multiplication factor based on level of stenosis Specific % stenosis is not used
Total Occlusion x5
Significant lesion 50-99% x2
100%
50%
99%
Lesion Location
Points added based on dominance x location of lesion:
Points +6 +5 +3.5 +2.5 +1.5 +1 +0.5
Total Occlusions (I)

Points added based on: Age >3 months or unknown Blunt occlusion
+1
Bridging occlusion
+1
+1
Total Occlusions (II)

Points added based on:
1st segment visible beyond occlusion per non-visible segment
+1
Open vessel Occlusion
Filled by contrast medium coming from collaterals
Total Occlusions (III)

Side branch complicates the opening of the TO; side branch not intended to be treated
<1.5mm
+1
1.5mm <1.5mm 1.5mm
This is a bifurcation with 1 side branch totally occluded at the ostium. Program will proceed with bifurcation/trifurcation questions
Both the small and large side branches are involved
+1
Bifurcations
Points added based on type of bifurcation:
Prebranch
Postbranch
Parent vessel only
+1 +2 +1
Bifurcation
Ostial
Prebranch Ostial
Ostial
Postbranch
Angulation <70
<70
Trifurcations
Points added based on # of diseased segments involved:
+2
1 segment involved 2 segments involved
+3
+4
3 segments involved
+5
4 segments involved
Additional Lesion Characteristics

Points added based on other adverse lesion characteristics: Aorto ostial lesion Severe tortuosity
+1
Lesion Length >20mm Heavy calcification
+1
+1
Thrombus Diffuse disease/ small vessels
+1
+1
+1
There is 3 Vessel Disease and 3 Vessel Disease
Example Case: Patient 2 (I)
RCA 100%
Lesion 1 Segment 1: 1x5 Age T.O. is unknown + Blunt stump + side branch First segment visualized by contrast: 4 +Tortuosity +Heavy calcification +Length

Lesion 1 Score:
16
5 1 1 1 3 2 2 1
Example Case: Patient 2 (II)
LM 99%
Lesion 2 Segment 5: 5x2 + Bifurcation Type A + Heavy calcification
Lesion 2 Score:
10 1 2
13
Example Case: Patient 2 (III)
LCX 100%
Lesion 3 Segment 11: 1,5x5 Age total occlusion is unknown + Blunt stump + side branch First segment visualized by contrast: 13 + Heavy calcification + Length
Lesion 3 Score:
14.5
7.5 1 1 1 1 2 1
Example Case: Patient 2 (IV)

LAD 99%
Lesion 4 Segment 6: 3, 5x2 + Bifurcation Type A + Angulation <70 + Heavy calcification
Lesion 4 Score: Total Score:
11 54.5
7 1 1 2
Raw SYNTAX Scores: Core Lab vs Site-reported

100
Range 0-84 Range 8-97 Range Range 0-83 5-80 Range 0-80
SYNTAX Score
Range 3-75 Range 0-72
Range 8-74
50
37.8
35.5
29.1
24.8
28.4
25.5
31.6
27.3
Core
Site
Core
Site
Core
Site
Core
Site
CABG Registry
CABG RCT
TAXUS RCT
PCI Registry
RCT ITT pts; Registries per protocol pts
Inter-observer Differences in SYNTAX Score Calculation (I)

70 60
r2=0.XX
Measurement 2
50 40 30 20 10 0 0 10 20 30 40 50 60 70
Measurement 1
Inter-observer Differences in SYNTAX Score Calculation (II)
Mean Meas. 1 Meas. 2 delta

SD 11.5 11.3 9.1

31.3 29.2 2.1
Inter-observer Differences in SYNTAX Score Calculation (III)

0-10 0-10 11-20 21-30 31-40 41-50 51-60 61 11-20 21-30 31-40 41-50 51-60 61
3 0 0 0 0 0 0
0 9 6 1 1 0 0
0 2 18 14 2 1 0
0 2 11 9 7 1 0
0 0 1 1 4 1 0
0 0 1 2 1 0 0
0 0 0 0 0 0 2
Inter-observer Differences in SYNTAX score Calculation (IV)

Core laboratory inter-observer variability of Syntax Score is 9.1 Inter-observer: SYNTAX score kappa=0.45 Inconsistency in scoring in the following variables
Presence of lesions in small vessels Bifurcations
Low Scores (0-22)

30
MACCE to 12 Months by SYNTAX Score Tercile

CABG (N=274) Cumulative Event Rate (%) TAXUS (N=299)
P=0.71*
20 14.4% 13.5%
10
6 Months Since Allocation
12
RCT ITT pts; site-reported data
Event Rate 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only
Intermediate Scores (23-32)

CABG (N=300) Cumulative Event Rate (%) 30

TAXUS (N=310)
P=0.10*
20
16.6% 11.7%
10
12
High Scores (33)

30

CABG (N=316) Cumulative Event Rate (%) TAXUS (N=290)
P<0.001*
23.3%
20 10.7%
10
12
MACCE to 12 Months vs SYNTAX Score

CABG (N=897) TAXUS (N=903)
P=0.007
23.4 16.7
12-month MACCE, %
30 25 20 15 10 5 0
P=0.38
14.7
12.0
10.9
13.6
P=0.04 P=0.29 P=0.002
22
23-32
33
22
23-32
33
SYNTAX Score
Summary
The SYNTAX score is a new, innovative tool to describe the complexity of vasculature The raw SYNTAX score is a good predictor of MACCE
PCI patients with lower raw SYNTAX scores have similar 12-month MACCE rates to CABG patients 12-month MACCE rates in CABG patients are comparable between patients with high or low SYNTAX scores Increasing SYNTAX scores (and lesion complexity) are related to increased adverse outcomes in PCI, whereas outcomes of CABG are independent of SYNTAX score
Conclusions
The SYNTAX score will be retroactively weighted based on clinical outcomes in SYNTAX and likely revised to optimize its prognostic value
The weighted score will be available for use in stratifying individual patients Once validated and standardized, the SYNTAX Score will become available online
The SYNTAX web tool will be available at www.syntaxscore.com

This site will include an online tutorial, a scoring system and the anticipated patient outcome according to the estimated score based on the SYNTAX trial data

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The SYNTAX Score

A new angiographic tool to grade the complexity of coronary artery disease

On behalf of the SYNTAX investigators

Patrick W. Serruys, MD, PhD

Study and Presentation Supported by Boston Scientific Corporation

SYNTAX Score Serruys

TCT 14 October 2008 Slide 2

The SYNTAX Trial

SYNTAX Score Serruys

TCT 14 October 2008 Slide 3

The Ultimate Goal of the SYNTAX Score

SYNTAX Score Methodology

SYNTAX Score Serruys

TCT 14 October 2008 Slide 5

Derivation of the SYNTAX Score

SYNTAX Score Serruys

Components of the SYNTAX Score

3 Vessel Total Occlusion

SYNTAX Score: How It Works (I)

Questions 1-3: determine dominance, total # of

Questions 4-12: detail adverse lesion

SYNTAX Score Serruys

TCT 14 October 2008 Slide 8

SYNTAX Score: How It Works (II)

www.syntaxscore.com Site under construction

SYNTAX Score Serruys

TCT 14 October 2008 Slide 9

Reduction in Vessel Diameter

Significant lesion 50-99% x2

SYNTAX Score Serruys

Total Occlusions (I)

SYNTAX Score Serruys

Total Occlusions (II)

Open vessel Occlusion

Filled by contrast medium coming from collaterals

SYNTAX Score Serruys

Total Occlusions (III)

1.5mm <1.5mm 1.5mm

Both the small and large side branches are involved

SYNTAX Score Serruys

Parent vessel only

SYNTAX Score Serruys

Additional Lesion Characteristics

There is 3 Vessel Disease and 3 Vessel Disease

SYNTAX Score Serruys

TCT 14 October 2008 Slide 18

Example Case: Patient 2 (I)

Example Case: Patient 2 (II)

Lesion 2 Segment 5: 5x2 + Bifurcation Type A + Heavy calcification

SYNTAX Score Serruys

TCT 14 October 2008 Slide 20

Example Case: Patient 2 (III)

Example Case: Patient 2 (IV)

Lesion 4 Segment 6: 3, 5x2 + Bifurcation Type A + Angulation <70 + Heavy calcification

Lesion 4 Score: Total Score:

SYNTAX Score Serruys

TCT 14 October 2008 Slide 22

Raw SYNTAX Scores: Core Lab vs Site-reported

Range 3-75 Range 0-72

SYNTAX Score Serruys

Inter-observer Differences in SYNTAX Score Calculation (I)

SYNTAX Score Serruys

TCT 14 October 2008 Slide 24