high SYNTAX Score? I Sheiban Division of Cardiology Interventional Card. University of Turin Turin / Italy

Transcription

1 What to do with patients with high SYNTAX Score? I Sheiban Division of Cardiology Interventional Card. University of Turin San Giovanni Battista Hospital Turin / Italy

2 Who are the patients with high SYNTAX Score Dominance Calcification Thrombus Bifurcation Number & location of lesions SYNTAX Score Left Main 3-vessel Total Occlusion Complex anatomy Multivessel disease Diffuse disease Tortuosity See Glossary for prescribing information outside the US

3 Patients in SYNTAX Randomized Controlled Trial Intent-to to-treat RCT: Enrolled N=1800 CABG n=897 vs PCI * n=903 RCT: 1 Year Follow-up N=1740 (96.7%) CABG n=849 vs PCI * n=891 RCT: 2 Year Follow-up N=1721 (95.6%) CABG n=836 vs PCI * n=885 * TAXUS Express

4 SYNTAX Score Anatomic ScoringFor Each Lesion Segment: Location Length Calcification Tortuosity Bifurcation Diffuse Disease Occlusion Thrombus SYNTAX Score = 18 SYNTAX Score = 41

5 SYNTAX Score : Low < 22 Intermediate : High : > 33

6 MACCE to 2 Years by SYNTAX Score Tercile Low Scores (0-22) CABG (N=171) TAXUS (N=181) CABG PCI P value 40 3VD Death 5.5% 5.1% 0.85 Cumulative Event Rat te (%) P= % 16.5% CVA 1.9% 1.2% 0.57 MI 4.2% 3.9% 0.90 Death, CVA or 9.7% 8.4% 0.67 MI Months Since Allocation Revasc. 7.6% 17.1% 0.01 Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

7 MACCE to 2 Years by SYNTAX Score Tercile Intermediate Scores (23-32) CABG (N=208) TAXUS (N=207) TAXUS CABG PCI P value 40 3VD Death 4.1% 6.4% 0.30 Cumulative Event Rat te (%) P= % 13.7% CVA 3.1% 2.0% 0.50 MI 2.6% 7.4% 0.03 Death, CVA or 8.6% 11.7% 0.29 MI Months Since Allocation Revasc. 73% 7.3% 16.1% 1% Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

8 MACCE to 2 Years by SYNTAX Score Tercile High Scores ( 33) 40 CABG (N=166) TAXUS (N=155) 3VD CABG PCI P value Death 2.5% 8.5% 0.02 Cumulative Event Rat te (%) P= % 13.3% CVA 1.9% 2.1% 0.95 MI 1.9% 7.2% 0.02 Death, CVA or 6.3% 13.7% 0.03 MI Months Since Allocation Revasc. 77% 7.7% 19.3% Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported data; ITT population

9 Patients (%) Stent Number and Length Higher in the SYNTAX Trial 48% of patients received 5 stents Multivessel disease: 96.2%* 3-vessel disease: 90.8% Avg. stents per patient: 4.6 ± 2.3 Avg. stented length: 86.1 mm Max # 14 stents! *3VD+LM/3VD+LM/2VD+LM/1VD Total Number of Stents Implanted per Patient

10 Linear Increase in MACCE by Number of Stentsin the SYNTAX Trial 0, Stents Typical Real World Average 4.6 Stents SYNTAX Average 17.8% Avg. in pts with 5-8+ stents in SYNTAX 19.6% 12m MACC CE in TA AXUS Ar rm 025 0,25 0,20 0,15 0, ,05 1stent 5.6% 12m MACCE Probability 12m MACCE Rate 0, Number of Stents Implanted

11 Based on these data : I can conclude at this point my presentation : No discussion : CABG is preferd in patients with high SYNTAX SCORE But what about CABG?

12 Durability of Saphenous Vein Grafts Diseased Occluded year 5 years 10 years 40 Goldman S. J Am Coll Cardiol. 2004

13 Cumulative patency (<70% stenosis) by type of graft Khot UN et al. Cleveland Clinic, Circulation 2004;109: B 5 i f l h 40% By 5 years, vein graft patency was less than 40%. It was even worse for radial artery conduits and not much better for RIMAs!

14 PCI vs CABG The Good Face of PCI Mini-invasivity invasivity Effectiveness of DES The Bad Face of PCI? Multiple stenting ( full metal Jacket ) Stent thrombosis Syntax Score

15 SYNTAX Trial : Not all MV disease are equal. MULTIVESSEL DISEASE Variables Anatomy Disease Extension MVD Disease Severity Patient comorbidity

16 SYNTAX Score Reproducibility in diffuse MV disease : Operator 1 : SYNTAX SCORE = 33 Operator 2 : SYNTAX SCORE = 22

17 SYNTAX Score Reproducibility Inter-observer Number of lesions 0.62 Bifurcation lesions 0.36 Ostial lesions 0.66 CTO lesions 0.91 Intra-observer : SYNTAx score grouped in deciles : 0.54 SYNTAX Score grouped in terciles: 0.51 Garg S. et al, CCI 2010 ; 75:

18 SYNTAX Score Reproducibility Garg S. et al, CCI 2010 ; 75:

19 SYNTAX Score & Functional Evaluation is not mandatory for every patient : SYNTAX Score = 12 PCI is an excellent option

20 SYNTAX Score & Functional Evaluation is not mandatory for every patient : SYNTAX Score = 38, CABG is 1 option

21 Diffuse Multivessel disease in diabetic patient Syntax Score = 47 Is this patient a good surgical candidate?

22 Multivessel Disease : SYNTAX Score : 37

23 At least 2 stents : At Least 2 stents At Least 2 stents Intention to treat : a total of at least 6 stents.. CABG should be the I choice

24 Multivessel Disease : Total Syntax Score = 37 Syntax Score= 14 Syntax Score= 23 CABG or PCI? CABG is preferd, but as alternative :

25 Good Option : PCI on prox LAD and prox LCX ( with 2 stents ) No intervntion on RCA

26 What is Is it the optimal approach? SYNTAX SCORE = 35 LAD treated with 7 stents! Certainly is not the optimal...

27 FFR-guided PCI? Stenting only lesions with FFR < 0.80

28 The use of Functional Evaluation ( FFR ) during MVD PCI reduce the number of stents t and MACE.. SYNTAX Score = 38

29 Angio-driven procedure = 6 stents Angio driven procedure 6 stents CABG is preferd. As altervnative :

30 FFR-driven procedure = 3 stents Functional SYNTAX Score = 17

31 Multivessel Disease SYNTAX SCORE = 46 Severe aortic calcification Severe coronary calcification CABG? Or PCI LCX and med LAD?

32 FFR=0.72 FFR =0.68 Distal CTO : Would PCI at this level change patient s outcome? Functional SYNTAX = 23 Functional SYNTAX = 23 FFR Guided PCI is a good option.

33 Functional SYNTAX Score 497 patients, FFR-guided arm of FAME Study 2-3 vessel disease Angio g Syntax Score : Conventional fashion Functional ( FFR) Syntax Score : counting only the lesions with FFR < 0.80 Angio SYNTAX Functional ( FFR ) SYNTAX FFR reclassifies > 30%! Fearon WF et al, TCT-MD 2011

34 Funtctional SYNTAX Score desciminates Risk of Death/MI and Risk of Total MACE Death / MI Total MACE Fearon WF et al, TCT-MD 2011

35 Is it safe to defer treatment?

36 DEFER Study : 5-year Follow-up o ( Death / MI )

37 FFR-Guided PCI in Multivessel Disease 137 patients, non-randomized Wongpraparut et al, AJC 2005; 96:

38 FAME study: Event-free Survival absolute difference in MACE-free survival FFR-guided 30 days 2.9% 90 days 38% 180 days Angio-guided 3.8% 4.9% 360 days 5.3%

39 FAME study: 2-year Event-free Survival

40 Stent length / Number of stent & restenosis stent thrombosis

41 Stent Length is Independent Predictor of Restenosis. Lee CW et al. Am J Cardiol 2006;97: % P< ,4 10 8,5 5 5,3 0 < ~ 40 > 40 mm

42 Multivariate Predictors of In-Segment Restenosis after SES RESEARCH Registry OR 95% CI p ISR <0.01 Ostial lesion <0.01 DM Stent length <0.01 Ref diameter LAD <0.01 Lemos PA et al. Circulation 2004;109:

43 Full Metal Jacket. Ielasi, Colombo et al. Ital J Inv Cardiol 2009; 3 Suppl: full metal jacket lesions ( 60mm) in 617 patients. 33% DM, 33 had prior PCI, 33% CTO. 39 months mean follow up (2 yr in 91% pts). Mortality 7.3% MI during follow up: 3.5% TLR: 23.4% Stent thrombosis (Def or Probable): 2.6% (10/17 while on DAP).

44 DES Thrombosis and Length DES Thrombosis and Length R. Moreno et al. JACC 2005;45:954-9

45 When long / multiple stents have restenosis. re-pci difficult and uneffective treatment and CABG is not anymore an option

46 PRACTICAL CONCLUSIONS MVD with high SYNTAX Score CABG should be considered as first choice paricularly when : Patients who Attempt need PCI - as if: ITT - > 4-5 stents > 1 clinically CABG relevant contraindicated CTO Patient/family and cardiac Inexperienced operator (<1000 PCI) surgeon agree on PCI Other cardiac surgery indications MVD With CABG High favored, SYNTAX but PCI Score is a without good alternative any of above unfavorable especially features: if FFR-guided A functional SYNTAX Score ( FFR ) can be more appropriate to select patients with MVD for a more appropriate treatment option

47 THANK YOU FOR YOUR ATTENTION