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Risk Scores for Appropriate Left Main Revascularizatione t a e ascu a at o
Corrado Tamburino, MD, PhDFull Professor of Cardiology, Director of Postgraduate School of Cardiology
Chief Cardiovascular Department, Director Cardiology Division, Interventional Cardiology and Heart Failure Unit, University of Catania, Ferrarotto Hospital, Catania, Italy
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Disclosure Statement of Financial Interest
I, Corrado Tamburino, DO NOT have a financial interest/arrangement or affiliationfinancial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflictbe perceived as a real or apparent conflict of interest in the context of the subject of this presentationthis presentation
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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ACC/AHA/SCAI 2011 PCI Guidelines: Emphasis on Patient-centeredDecision-MakingDecision Making
CABG mortality risk
Likelihood of good long-term outcome
Risk of PCI complications
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Levin GN et al. J Am Coll Cardiol 2011;58:44-122
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2011 ACC/AHA/SCAI SYNTAX score-based recommendations for LM PCI
Anatomy at low risk of PCI proceduralAnatomy at low risk of PCI procedural complications (e.g., a low SYNTAX score of 22, ostial or trunk left main CAD) and increased li i l i k f d i l t (
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
clinical risk of adverse surgical outcomes (e.g., STS score ≥5)
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIIIAnatomy at low to intermediate risk of PCI procedural complications (e.g., low-intermediate SYNTAX score of 2)III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Unfavorable anatomy for PCI in good candidates for CABG
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Levin GN et al. J Am Coll Cardiol 2011;58:44-122
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2012 Appropriateness criteria for LM revascularization: what about patients with intermediate SYNTAX score?
ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT PCI CABG
Isolated left main stenosis U A
Left main stenosis and additional CAD with low CAD burden (i.e., 1- to 2-vessel additional involvement, lowSYNTAX score)
U A
Left main stenosis and additional CAD with intermediate to high CAD burden (i.e., 3-vessel involvement, presence I Ag ( , , pof CTO, or high SYNTAX score)
I A
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Patel M et al. JACC 2012;59:857-81
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Risk Stratification in LM Disease
Angiographic Clinical Combined Functional• SYNTAX score
(Sxscore)• Residual
SYNTAX score
• EuroSCORE• EuroSCORE 2*• STS score*
C
• GRC• CSS• Logistic CSS*
S
• FunctionalSYNTAX score (FSS)*
• Non invasiveSYNTAX score (rSS)*
• ACEF score • NERS • Non-invasive FSS*
*not yet presented or validated in LM PCI
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Risk Stratification in LM Disease
Angiographic Clinical Combined Functional• SYNTAX score
(Sxscore)• Residual
SYNTAX score
• EuroSCORE• EuroSCORE 2*• STS score*
C
• GRC• CSS• Logistic CSS*
S
• FunctionalSYNTAX score (FSS)*
• Non invasiveSYNTAX score (rSS)*
• ACEF score • NERS • Non-invasive FSS*
*not yet presented or validated in LM PCI
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Fact #1 –The SYNTAX score usefully discriminates MACE and MACCE between patients at low risk and those at high risk undergoing left main PCI
32-month MACE 3-year MACCE1-year MACCE 1-year MACE
ΔHIGH-LOW+21%
ΔHIGH-LOWΔ Δ HIGH LOW+5%ΔHIGH-LOW+17%
ΔHIGH-LOW+10%
Brito et al.J Invas Cardiol 2011
MAIN COMPAREJACC Interv 2010
SYNTAXCirculation 2010
Capodanno et al.Circ Card Interv 2009
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Fact #2 – In observational registries, the intermediate tertile is frequently poorly calibrated with respect to the outcomes of the high and low tertiles
32-month MACE 3-year MACCE1-year MACCE 1-year MACE
14 0%-11.2%
+6 5%+14.0% +6.5%
Brito et al.J Invas Cardiol 2011
MAIN COMPAREJACC Interv 2010
SYNTAXCirculation 2010
Capodanno et al.Circ Card Interv 2009
Expected risk for the intermediate stratum
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Expected risk for the intermediate stratum
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Fact #3 – The SYNTAX score is also a good predictor of hard events but, once again, the intermediate stratum is generally not well calibrated
32-month cardiac death
3-year death/MI/CVA
1-year death 1-year cardiac death
ΔHIGH-LOW =+22% ΔHIGH-LOW =+6%ΔHIGH-LOW =+9% ΔHIGH-LOW =+11%
Brito et al.J Invas Cardiol 2011
MAIN COMPAREJACC Interv 2010
SYNTAXCirculation 2010
Capodanno et al.Circ Card Interv 2009
Expected risk for the intermediate stratum
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Expected risk for the intermediate stratum
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Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Capodanno et al, Am Heart J 2011;161:462-70
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The SYNTAX score does not include any subset of lesions
In-stent t i
LIMAs and SVG
Coronary li
Muscular b id
Coronaryrestenosis SVGs anomalies bridges aneurysms
How would you grade these lesions?
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Is the SYNTAX score time-consuming?g
1 Launching the calculator1. Launching the calculator
2. Specify diseased segments
3. Characterize complexity
4. Add another lesion
~ 6-8 minutes for h i tieach examination
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Solution - You don’t have to score each patient!p
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Capodanno et al, Int J Cardiol 2012 Ahead of print
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Only patients with lesions eligible to both y p gprocedures should be scored
SYNTAX patient disposition
42% of patients do not needdo not need scoring for being assigned to PCI or CABGor CABG
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Capodanno et al, Int J Cardiol 2012 Ahead of print
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Vessel distribution in LM diseasePatients with low SYNTAX SYNTAX trial
18%
5%25%
80%
90%
100%low SYNTAX score have virtually no 3VD
42%71%
50%
60%
70%
67%
20%
30%
40%
50%
8% 2%
27%
0%
10%
20%
L SYNTAX I t di t SYNTAX Hi h SYNTAX
Patients with high SYNTAX score have virtually no
35%
Low SYNTAX score Intermediate SYNTAX score High SYNTAX score
LM isolated LM + 1VD LM + 2VD LM + 3VD
isolated LM or LM+1VD
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
A practical implication: You do not need to score patients with isolated LM or LM + 1VD (33% of those with LM disease randomized in the SYNTAX)
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Cumulatively, only 51% of patients with complex y, y p pCAD need to be scored
SYNTAX patient disposition
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Capodanno et al, Int J Cardiol 2012 Ahead of print
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The SYNTAX score suffers from moderate interobserver and intraobserver variability
Interobserver reproducibility: k = 0.45I t b d ibilit k 0 59Intraobserver reproducibility: k = 0.59
Weighted k valuesWeighted k values
2009 2010Number of lesions 0 59 0 62Number of lesions 0.59 0.62Bifurcation lesions 0.41 0.36Ostial lesions 0.63 0.66Total occlusions 0.82 0.91
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Serruys PW, Eurointervention 2009;5:50-6Garg S, Catheter Cardiovasc Interv 2010;1:946-52
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Angiography is not enoughg g p y g
5% Clinical and angiographic1917%
11%5%
ore
Clinical and angiographic scores summarize very different information in patients with unprotected
27
5% and EuroSCORE(RS=0.204, p = 0.001)
0-2 3-6 > 6EuroSCORE
The frequency of patients for each cross-tabulation cell is shown within a rectangle that is proportional in size to the frequency
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Capodanno et al, Am Heart J 2010:159:103-9
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GRC – Prognostic ability in improving bothdiscrimination and calibration vs SYNTAX score
%) 10
th fr
ee s
urvi
val (
% 100
90
80
96.1%
94.6%
78.1%P = 0.004*SYNTAX score
Car
diac
dea
t
70
60SYNTAX score
LOWMIDDLEHIGHL L I0-2
27SYNTAX score
E
Time (months)0 12 24
val (
%) 10
098.4%
L L IL L I3-6
uroS
CO
RE
c de
ath
free
sur
viv
90
80
70
84.0%
P < 0.001*I I H> 6E
u
Car
diac 70
60
Time (months)0 12 24
GRC68.6%LOW
MIDDLEHIGH
* log rank test; n = 255 LM patients undergoing PCI
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Capodanno D et al. Am Heart J 2010;159:103-9
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Cardiac death to 2 Years by stratification ofGRC and CSS in LM PCI (N = 400)
LOW MIDDLE HIGHLOW MIDDLE HIGH
)
40
)
40Global Risk Classification Clinical SYNTAX score
ent R
ate
(%)
30
ent R
ate
(%)
30P < 0.001* P < 0.001*24.2% 25.6%
ΔHIGH LOW = 23 6% ΔHIGH LOW = 23 0%HL = 0.357 c-statistic = 0.74 HL = 3.833 c-statistic = 0.76
mul
ativ
e Ev
e
20
10
mul
ativ
e Ev
e
20
108.7%
ΔHIGH-LOW = 23.6% ΔHIGH-LOW = 23.0%
Cu
0
Ti ( th )0 12 24
Cu
0
Ti ( th )0 12 24
0.6% 2.6%
1.0%
* log rank test; higher HL (Hosmer-Lemeshow) statistic indicates poorer calibration; higher ΔHIGH-LOW (Index of separation) indicates better discrimination
Time (months) Time (months)
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Capodanno D et al. JACC Interv 2011;4:287-97
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Accuracy is a function of two characteristics
0.00
The The idealidealscore for score for LM PCILM PCI
1.00
0.00sh
ow
ette
r
Discrimination
LM PCILM PCI
2.00
mer
-Lem
es
tion
be
DiscriminationMeasures how much the score can differentiate between
3.00Hos
m
alib
rat differentiate between
poor and good outcomes
0.60 0.65 0.70 0.75 0.80
4.00
Ca
CalibrationMeasures how close the estimates are to a
C-statistic
Discrimination betterreal probability
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Stand-alone Scores Are Far from Perfection
0.00The The idealidealscore forscore forACEF
1.00
0.00
show
ette
rscore for score for LM PCILM PCI
ACEF
2.00
mer
-Lem
es
tion
be EuroSCORE
SYNTAX Score
3.00Hos
m
alib
rat SYNTAX Score
0.60 0.65 0.70 0.75 0.80
4.00
Ca
C-statistic
Discrimination better
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Capodanno D et al. JACC Interv 2011;4:287-97
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GRC approaches the ideal model for LM PCI
0.00ACEF The The idealideal
score forscore forACEF GRC
1.00
0.00
show
ette
rEuroSCORE
score for score for LM PCILM PCI
ACEF GRC
2.00
mer
-Lem
es
tion
be
SYNTAX Score
EuroSCORE
SYNTAX Score
3.00Hos
m
alib
rat SYNTAX Score
CSS
0.60 0.65 0.70 0.75 0.80
4.00
Ca
C-statistic
Discrimination better
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Capodanno D et al. JACC Interv 2011;4:287-97
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Lessons on the GRC from the SYNTAX trial
DeathMACCE
Excellent mortality stratificationImproved MACCE stratification
The GRC may help to identify a population at very low risk of events after LM PCI
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Serruys et al., presented at LM Summit 2011
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PCI vs CABG in LM Patients with Low GRC in the SYNTAX Trial at 3 Years
HR 0.16, 95% CI HR 0.16, 95% CI 0.030.03--0.70, 0.70, P=0.005P=0.005
HR 0.64, 95% CI 0.39HR 0.64, 95% CI 0.39--1.07, 1.07, P=0.088P=0.088
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Serruys et al. J Am Coll Cardiol 2011;58:87 (abstract)
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Decision-making based on the Global RiskClassification
≤22 22-32 ≥32
SYNTAX score The comparative role of PCI and CABG in LM patients in the intermediate
PCI PCI ?0-2patients in the intermediate GRC risk group (≈40%) is not well defined
PCI PCI ?3-5
roSC
OR
E
? ? CABG≥6
Eur
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
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Decision-making based on the Global RiskClassification: cardiac death
PCI
≤22 22-32 ≥32
SYNTAX score P=0.65
PCI PCI INT20-2
PCI PCI INT23-5
roSC
OR
E
CABG
P=0 22
INT1 INT1 CABG≥6
Eur P 0.22
INT1 = high clinical/acceptable angiographic riskINT2 = acceptable clinical/high angiographic risk
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania
Capodanno D et al. Int J Cardiol 2011;150:116-7
2 g g g
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Decision-making based on the Global RiskClassification
≤22 22-32 ≥32
SYNTAX score Performing CABG in patients with SYNTAX score ≥32 complies with
PCI PCI CABG0-2score ≥32 complies with guidelines
The efficacy and safety of
PCI PCI CABG3-5
roSC
OR
E The efficacy and safety of performing PCI in patients with SYNTAX score
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Key remarks
No one should be so self-confident as to favor his own opinion as the only effective prognosticown opinion as the only effective prognostic parameter. The SYNTAX score is a nice step forward in the objectificaction of clinical decisionsin the objectificaction of clinical decisionsHowever, the SYNTAX score is imperfect as it does not rely on clinical and functional information. yTherefore, it should not be idealized as a dogmaTime and variability issues should not contraindicate ythe use of the SYNTAX score. These problems can be addressed by calculating the score only in doubtful cases, in which an objective measure may really affect clinical decisions
Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania