SYNTAX score before decision making! Corrado Tamburino, MD, PhD

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SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 1 SYNTAX score before decision making! Corrado Tamburino, MD, PhD Full Professor of Cardiology, Director of Postgraduate School of Cardiology Chief Cardiovascular Department, Director Cardiology Division, Interventional Cardiology and Heart Failure Unit,,, Catania, Italy

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 2 Disclosure statement of financial interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below Consulting fees/honoraria: Medtronic, Abbott Vascular, Boston Scientific, Stentys, Celonova

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 3 Capodanno, Tamburino. Am Heart J 2011;161:462-70

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 4 Why do we need risk stratification in complex coronary artery disease? Diagnostic and prognostic models: Drive informed clinical decisions because they allow the selection of the most appropriate strategy of treatment based on the patient's individual characteristics Help patients and their families to get a better understanding of issues relevant to treatment strategies and subsequent risks as part of the process to obtain informed consent Assist quality-of-care monitoring and facilitate a fair comparison of procedures performed in different clinical scenarios Are valuable aids for stratifying patients by disease severity in clinical trials Capodanno, Tamburino. Am Heart J 2011;161:462-70

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 5 Currently used Clinical and Angiographic Scores in Left Main Disease ESC guidelines 2010

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 6 The SYNTAX score usefully discriminates MACE and MACCE between patients at low risk and those at high risk in patients undergoing left main PCI 1-year MACCE 1-year MACE 32-month MACE 3-year MACCE HIGH-LOW +21% +17% HIGH-LOW +10% HIGH-LOW HIGH-LOW +5% SYNTAX Circulation 2010 Capodanno et al. Circ Card Interv 2009 Brito et al. EuroPCR 2010 MAIN COMPARE JACC Interv 2010 Capodanno, Tamburino. Am Heart J 2011;161:462-70

Unadjusted 2-Year incidence of mortality stratified tifi by SYNTAX score CUSTOMIZE Registry (n = 819) Cardiac de eath (%) SYNTAX score 34 SYNTAX score > 34* 50 50 40 30 20 10 0 P = 0.461 PCI, n = 257 CABG, n = 273 5.1% 4.5% 8.1% 0 6 12 18 24 Time (months) 6.2% Cardiac de eath (%) 40 30 20 10 0 P < 0.001 PCI, n = 85 CABG, n = 204 15.0% 6.8% 32.7% 8.5% 0 6 12 18 24 Time (months) *p for interaction between SYNTAX score >34 and treatment < 0.001; adjusted HR for SYNTAX score > 34 2.54 (95% CI 1.09-5.92), p = 0.031 Capodanno, et al. J Am Coll Cardiol Intv 2009;2:731-8

Differences of complete revascularization rates per revascularization treatment * = 12.5% = 40.6% * when forced into the Cox multivariable proportional hazard regression model, complete revascularization was found to be an independent predictor of lower mortality (HR 0.55, 95% CIs 0.31-0.98, p = 0.041), but this finding did not affect the prognostic significance of a SYNTAX score. Conversely, treatment type was no longer a significant predictor of mortality Capodanno, et al. J Am Coll Cardiol Intv 2009;2:731-8

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 9 Indications for CABG vs PCI in stable patients with lesions suitable for both procedures and low predicted d surgical mortality Subset of CAD by anatomy Favours CABG Favours PCI 1VD or 2VD non proximal LAD IIb C I C 1VD or 2VD proximal LAD I A IIa B 3VD simple lesions, full functional revascularization achievable with PCI, SYNTAX score 22 3VD complex lesions, incomplete revascularizarion achievable with PCI, SYNTAX score > 22 I A I A IIa B III A Left main (isolated or 1VD, ostium/shaft) I A IIa B Left main (isolated or 1VD, bifurcation) I A IIb B Left main + 2VD or 3VD, SYNTAX score 32 I A IIb B Left main + 2VD or 3VD, SYNTAX score 33 I A III B ESC guidelines 2010

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 10 Pitfalls and issues relevant to SYNTAX score application in clinical practice Does not include any subset of lesions (i.e. in-stent restenosis, stenotic bypass grafts, coronary anomalies, muscular bridges, aneurysms) Time-consuming Interobserver and intraobserver variability Does not account for clinical or procedural variables that are known for impacting the outcomes during and after PCI Capodanno, Tamburino. Am Heart J 2011;161:462-70

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 11 Why do we need both clinical and angiographic variables? e SYNTA TAX scor <19 19-27 5% 10% 17% 18% 11% Clinical and angiographic scores summarize very different information in 255 patients with unprotected LM 8% Low Spearman rank correlation coefficient >27 8% 17% between SYNTAX score 5% and EuroSCORE (R S =0.204, p = 0.001) 0-2 3-6 >6 EuroSCORE 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

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 12 5 % 10 % 8 % 17% 11 % 18% 17% EuroSCO ORE 0-2 3-6 > 6 8 % 5 % The Global Risk Classification (GRC) SYNTAX score < 19 19-27 > 27 L L I L L I I I H * log rank test; n = 255 LM patients undergoing PCI Improved calibration Card diac death free e survival (%) Cardiac death free su urvival (%) 100 90 80 70 60 100 90 80 70 60 P = 0.004* LOW MIDDLE HIGH SYNTAX score 96.1% 94.6% 78.1% 0 12 24 Time (months) P < 0.001* LOW MIDDLE HIGH GRC 98.4% 84.0% 68.6% 0 12 24 Time (months) Capodanno, et al. Am Heart J 2010:159:103-9

3-year Death Stratified by SXscore and GRC in the SYNTAX LM Cohort 40 GRC GRC GRC HIGH MID LOW With With GRC SXscore alone 30 30.0% 0% 13.4% HIGH = +16.6% 20 13.1% 1% 49% 4.9% 10 MID = +8.2% 0 0 12 24 36 2.7% LOW = +0.1% 2.6%

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 14 Prediction accuracy of different risk models 4.00 PCI CABG CSS Hosm mer-leme eshow 3.00 2.00 1.00 0.00 SYNTAX score CSS EuroSCORE GRC SYNTAX score EuroSCORE ACEF ACEF GRC Cal ibratio on bett ter 0.55 0.60 0.65 0.70 0.75 0.80 C-statistic Discrimination better Capodanno, et al. JACC Interv 2011;4:287-97

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 15 24-month cardiac mortality with PCI vs CABG* HR LCL UCL p SYNTAX score 0-22 0.348 0.084 1.445 0.146 SYNTAX score 23-32 0.582 0.177 1.910 0.372 SYNTAX score > 32 2.323 1.091 4.945 0.029 EuroSCORE 0-2 0.293 0.025 3.482 0.331 EuroSCORE 3-6 1.753 0.709 4.339 0.224 EuroSCORE > 6 1.091 0.452 2.638 0.846 ACEF 0-1.2 1.431 0.115 17.804 0.781 ACEF 1.2-1.4 1.511 0.552 4.134 0.421 ACEF > 1.4 1.107107 0.521 2.352 0.793 LOW GRC 0.557 0.129 2.407 0.434 MID GRC 1.174 0.475 2.904 0.728 HIGH GRC 1.760 0.648 4.779 0.267 LOW CSS 0.467 0.103 2.122 0.324 MID CSS 0.929 0.268 3.218 0.908 HIGH CSS Favors PCI Favors CABG 1.711 0.810 3.615 0.159 0.01 0.1 1 10 100 * adjusted by propensity score; HR indicates hazard ratio; LCL indicates lower confidence limit; UCL indicates upper confidence limit Capodanno, et al. JACC Interv 2011;4:287-97

Why does it happen? An egg of Columbus Good risk stratification both in PCI and CABG te (%) 40 30 P < 0.05 P < 0.05 Example #1 P = NS P = NS Event Rat 20 10 P = NS 0 PCI CABG PCI vs CABG Good risk stratification in PCI and BAD risk stratification in CABG Event Rate (%) 40 30 20 10 0 Example #2 P < 0.05 P = NS P < 0.05 P = NS P = NS PCI CABG PCI vs CABG

SYNTAX score in left main - Tamburino TCT Asia Pacific Seoul, 27 April 2011 Slide 17 Closing remarks Standardized risk stratification is of paramount importance in complex PCI. Eyeball risk stratification is ok if you have Antonio Colombo in your cath lab. Otherwise, use stand-alone and combined scores Adding clinical variables requires more time, but improves the discrimination and calibration ability of the SYNTAX score alone for prognostic purposes. Risk redistribution may be useful especially in low and intermediate risk patients. Conversely, the good predictive ability in the PCI scenario along with the poor predictive ability in the CABG scenario make the SYNTAX score the preferable tool to guide decision- making in LM CAD