Risk Scores for Appropriate Leetft Main Ree ascu a at ...summitmd.com/pdf/pdf/4_Tamburino.pdf · Heart Failure Unit, University of Catan ia, Ferrarotto Hospital, Catania, Italy Ferrarotto

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

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


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

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

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

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


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


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%





Expected risk for the intermediate stratum



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%








Ferrarotto HospitalUniversity of CataniaFerrarotto HospitalUniversity of Catania Capodanno et al, Am Heart J 2011;161:462-70

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?


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


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

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


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


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)

Cumulatively, only 51% of patients with complex y, y p pCAD need to be scored

SYNTAX patient disposition


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


Serruys PW, Eurointervention 2009;5:50-6Garg S, Catheter Cardiovasc Interv 2010;1:946-52

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


Capodanno et al, Am Heart J 2010:159:103-9

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


Capodanno D et al. Am Heart J 2010;159:103-9

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)


Capodanno D et al. JACC Interv 2011;4:287-97

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


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



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



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


Serruys et al., presented at LM Summit 2011

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


Serruys et al. J Am Coll Cardiol 2011;58:87 (abstract)

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


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


Capodanno D et al. Int J Cardiol 2011;150:116-7

2 g g g

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

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


Documents

Risk Scores for Appropriate Leetft Main Ree ascu a at ...summitmd.com/pdf/pdf/4_Tamburino.pdf · Heart Failure Unit, University of Catan ia, Ferrarotto Hospital, Catania, Italy Ferrarotto