presentation-syntax-score-tct-2008.pdf

The SYNTAX Score

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

The SYNTAX ScoreThe SYNTAX Score

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

Patrick W. Serruys, MD, PhDOn behalf of the SYNTAX investigators

SYNTAX Score • Serruys TCT • 14 October 2008 • Slide 2

Conflicts of InterestConflicts of Interest

None

Study and Presentation Supported by Boston Scientific Corporation


The SYNTAX TrialThe SYNTAX Trial

Provides evidence-based medicine comparing modern CABG vs PCI in patients with 3VD and/or LM diseasePatient and lesion complexity not included in prior studiesDetermines 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


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

The Ultimate Goal of the SYNTAX The Ultimate Goal of the SYNTAX ScoreScore


SYNTAX Score MethodologySYNTAX 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 ScoreDerivation 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)Combination of the Duke and ICPS classification of Bifurcation (Cathet Cardiovasc Intervent 2000; 49:274-283)Total occlusion classification (J Am CollCardiol,1997;30:649-56)Consultation of experts


Components of the SYNTAX ScoreComponents of the SYNTAX Score

Number & location of

lesions

Tortuosity

Thrombus

BifurcationTotal

Occlusion

3 Vessel

Left Main

Dominance

SYNTAXscore

Calcification

EuroInterv 2005;1:219-227


SYNTAX Score: How It Works (I)SYNTAX Score: How It Works (I)

The SYNTAX score is lesion basedA separate number calculated per lesion

Summed to generate the total SYNTAX score

Questions 1-3: determine dominance, total # of lesions and vessel segments/lesionQuestions 4-12: detail adverse lesion characteristics; are repeated for each lesionThe SYNTAX score is calculated after answering a set of sequential, interactive self-guided questions


SYNTAX Score: How It Works (II)SYNTAX Score: How It Works (II)

www.syntaxscore.comSite under construction


Reduction in Vessel Diameter 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 Occlusionx 5

Significant lesion 50-99%x 2

100% 50% 99%



Points

+6

+5

+3.5

+2.5

+1.5

+1

+0.5

Points added based on dominance x location of lesion:

Lesion LocationLesion Location



Points added based on:Age >3 months or unknown

Blunt occlusion Bridging occlusion

Total Occlusions (I)Total Occlusions (I)

+1+1

+1+1 +1+1



Points added based on:1st segment visible beyond occlusion

per non-visible segment

Total Occlusions (II)Total Occlusions (II)

Open vessel

Occlusion

Filled by contrast medium coming from collaterals

+1+1



Total Occlusions (III)Total Occlusions (III)

+1+1

+1+1

This is a bifurcation with 1 side branch totally occluded at the ostium. Program will proceed with bifurcation/trifurcation questions

<1.5mm

≥1.5mm

<1.5mm

≥1.5mm

Side branch complicates the opening of the TO; side branch not intended to be treated

Both the small and large side branches are involved



BifurcationsBifurcations

+1+1

+2+2

Angulation <70º +1+1

Points added based on type of bifurcation:

<70º


PrebranchPostbranch Parent vessel

only

Bifurcation OstialPrebranchOstial

Postbranch

Ostial


TrifurcationsTrifurcations

+2+2+3+3

+4+4 +5+5

Points added based on # of diseased segments involved:


1 segment involved 2 segments involved

3 segments involved 4 segments involved


Aorto ostial lesion Severe tortuosity

Lesion Length >20mm Heavy calcification

Thrombus “Diffuse disease”/small vessels

Additional Lesion CharacteristicsAdditional Lesion Characteristics

+1+1

+1+1

+1+1

+1+1

+1+1

+1+1


Points added based on other adverse lesion characteristics:


There is ‘3 Vessel Disease’ and ‘3 Vessel Disease’


RCA 100%RCA 100%

Lesion 1• Segment 1: 1x5 5• Age T.O. is unknown 1• + Blunt stump 1• + side branch 1• First segment visualized by contrast: 4 3• +Tortuosity 2• +Heavy calcification 2• +Length 1Lesion 1 Score:

Example Case: Patient 2 (I)Example Case: Patient 2 (I)

16


Lesion 2Segment 5: 5x2 10+ Bifurcation Type A 1+ Heavy calcification 2

Lesion 2 Score:

LM 99%LM 99%

Example Case: Patient 2 (II)Example Case: Patient 2 (II)

13


Lesion 3Segment 11: 1,5x5 7.5Age total occlusion is unknown 1+ Blunt stump 1+ side branch 1First segment visualized by contrast: 13 1+ Heavy calcification 2+ Length 1

Lesion 3 Score:

LCX 100%LCX 100%

Example Case: Patient 2 (III)Example Case: Patient 2 (III)

14.5


Lesion 4Segment 6: 3, 5x2 7+ Bifurcation Type A 1+ Angulation <70° 1+ Heavy calcification 2

Lesion 4 Score:

Total Score:

LAD 99%LAD 99%

Example Case: Patient 2 (IV)Example Case: Patient 2 (IV)

54.5

11


Range3-75 Range

0-72

Range0-84

Range0-83

Range0-80

Range8-97 Range

5-80 Range8-74

SYN

TAX

Scor

e

RCT ITT pts; Registries per protocol pts

Raw SYNTAX Scores: Core LabRaw SYNTAX Scores: Core Labvs Sitevs Site--reportedreported

Core Site Core Site Core SiteCore Site

37.829.1 28.4 31.6

24.8 25.5 27.335.5

0

50

100

CABG Registry CABG RCT TAXUS RCT PCI Registry


InterInter--observer Differences in observer Differences in SYNTAX Score Calculation (I)SYNTAX Score Calculation (I)

Measurement 1

Mea

sure

men

t 270

60

50

40

30

20

10

00 10 20 30 40 50 60 70

r2=0.XX


9.12.1delta

11.329.2Meas. 2

11.531.3Meas. 1

SDMean

InterInter--observer Differences in observer Differences in SYNTAX Score Calculation (II)SYNTAX Score Calculation (II)


2 000000≥61

001110051-60

014721041-50

0219141031-40

01111186021-30

000229011-20

00000030-10

≥6151-6041-5031-4021-3011-200-10

InterInter--observer Differences in observer Differences in SYNTAX Score Calculation (III)SYNTAX Score Calculation (III)


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

InterInter--observer Differences in observer Differences in SYNTAX score Calculation (IV)SYNTAX score Calculation (IV)


13.5%14.4%

TAXUS (N=299)CABG (N=274)

P=0.71*

0 6 12

20

30

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

)

10

Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only RCT ITT pts; site-reported data

MACCE to 12 Months by SYNTAX MACCE to 12 Months by SYNTAX Score Score TercileTercileLow Scores (0Low Scores (0--22) 22)


16.6%

11.7%


P=0.10*

0 6 12

20

30

0


Cum

ulat

ive

Even

t Rat

e (%

)

10

RCT ITT pts; site-reported dataEvent Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only

MACCE to 12 Months by SYNTAX MACCE to 12 Months by SYNTAX Score Score TercileTercileIntermediate Scores (23Intermediate Scores (23--32) 32)


23.3%

10.7%


P<0.001*

0 6 12

20

30

0


Cum

ulat

ive

Even

t Rat

e (%

)

10

RCT ITT pts; site-reported dataEvent Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only

MACCE to 12 Months by SYNTAX MACCE to 12 Months by SYNTAX Score Score TercileTercileHigh Scores (High Scores (≥≥33) 33)


14.712.0 10.9

0

5

10

15

20

25

30

13.616.7

23.4

≥33

MACCE to 12 Months MACCE to 12 Months vsvs SYNTAX SYNTAX ScoreScore


≤2223-32 ≥33≤22 23-32

PP=0.38=0.38 P=0.007

PP=0.29=0.29

PP=0.002=0.002

PP=0.04=0.04

12-m

onth

MAC

CE, %

SYNTAX ScoreRCT ITT pts; site-reported data


SummarySummary

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


ConclusionsConclusions

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 patientsOnce 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

presentation-syntax-score-tct-2008.pdf

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