Thierry Folliguet Service de chirurgie cardiovasculaire & transplantation CHU Brabois, Vandoeuvre les Nancy t.folliguet@chu-nancy.

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1 Thierry Folliguet Service de chirurgie cardiovasculaire & transplantation CHU Brabois, Vandoeuvre les Nancy Congrès de Chirurgie Thoracique et Cardio-Vasculaire du 12 au 15 juin 2013 La Chirurgie coronaire reste t elle le Gold Standard de la revascularisation myocardique?

2 Conflits d Intérêts Sorin Edwards C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

3 La Chirurgie coronaire reste t elle le Gold Standard de la revascularisation myocardique? Medical Chirurgie 1967 C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

4 The superiority of CABG to medical therapy in the management of specific subsets of CAD was first established in a meta analysis of seven randomized trials by Yusuf and colleagues in 1994 Yusuf S, Zucker D, Peduzzi P, et al. Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet 1994; 344: C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

5 VA study CASS MASS II C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

6

7 Diminution chirurgie cardiaque France = - 13% (source ATIH 2011) = (-)25% coronaires (+) 40% valvulaires

8 L angioplastie est t elle devenue le Gold Standard de la revascularisation myocardique? Medical Angioplastie 1979

9 Diminution de 14% PAC de Augmentation de 35% angioplasties

10 Angioplasties France source GACI D Blanchard

11 Angor stable PCI + OMT OMT Hazard ratio: % CI ( ) P = Overall survival

12 Registres / Etudes Randomisées CABG vs PCI (avant SYNTAX)

13 Randomized Controlled Trials vs Registry BARI CABG 914 PCI 915 CABG > PCI 10y CABRI CABG 513 PCI 541 4y EAST CABG 194 PCI 198 8y ARTS n=1205 CABG 605 PCI 600 CABG =PCI 5y French Monocentric study CABG 76 PCI 76 5y SOS CABG 500 PCI 488 3y GABI CABG 177 PCI y ERACI II n=230 CABG 225 PCI 225 CABG =PCI 5y AWESOME n=454 CABG =PCI 5y RCT FREEDOM n=2000 DM Ongoing Syntax CABG 900 PCI 900 Combat Registry Awesome n=1650 CABG 692 PCI 651 Medical 307 CABG =PCI SCAAR California CABG PCI Danish Heart n= CABG = PCI STS > 3M Euro Heart Survey n=7769 NY registry CABG PCI ERACI III n=230 CABG 225 PCI 225 CABG >PCI 3 years ACC NCDR > 5M

14 4 Problems with Evidence in the Literature RCT Often small and not representative of real practice Enrol 5-10% of eligible patients 2/3 of patients have 1 or 2vd and normal EF Only 40% have proximal LAD disease Meta-analyses cannot overcome this problem Registry data Represents real clinical practice Consistently identify survival benefit with CABG vs RCT Consistently report x4-x7 repeat intervention with PCI (as in RCT) Have both known and unknown confounding factors Many trials/registries have limited duration of follow-up Often 2-3 years Trials and Registries confounded by cross-overs (up to 40%)

15 Chirurgie Bénéfice comfirmé sur la survie Revascularisation Coronaire Complexe:Avant SYNTAX Author Year Patients DM Stents Follow-Up CABG vs PCI Hannan NEJM ,400p - DES 1.5 yrs HR 0.8 (p=0.03) Bair CIRC ,369 - DES 5 yrs HR 0.85 (p<0.001) Javaid CIRC ,680 - DES 1 yr 97% vs 89% Hannan NEJM ,314p - BMS 3 yrs mortality 5% Malenka CIRC ,493 - BMS 7 yrs HR 0.6 (p <0.01) BARI JACC yrs 58% vs 46% Javaid CIRC DES 1 yr 3% vs 12-18% Niles JACC , yrs HR SUMMARY 102, yrs mortality In >100,000 propensity matched patients PCI with stents vs chirurgie Diminution de la survie de 5% à 3 ans par rapport à la chirurgie

16 NEJM 2005 onew York Registry: 37,212 CABG and 22,102 PCI (BMS) patients with > 2VD Propensity matched for cardiac and non-cardiac co-morbidity risk Absolute Survival Benefit of 5% with CABG at 3 years Reintervention at 3 years: 35% of PCI vs 5% CABG 31% risk of death

17 PCI is not as effective as CABG in the real world Long Term Survival in patients with multivessel disease after CABG or PCI Malenka, D. J. et al. Circulation 2005 oeffect true for all (elderly, gender, DM, stents, EF </> 40%) Conclusion: In contemporary practice survival for patients with 3-vessel coronary artery disease is better after CABG than PCI, an observation that patients and physicians should carefully consider when deciding on revascularization strategy

18 MACE PAC 9.9% vs 24.5% ATC (p< ) Lancet 2009; 373; patients with median follow up of 6 years >2/3 with 1 or 2 vessel disease and normal LV function Mortality CABG = PCI [CABG:PCI HR = 0.91 (95% CI ; p=0.12)] Survival: CABG > PCI : diabetes (HR 0.70; 95% CI ; p=0.014) [BARI-2D NEJM 2009] patients >65 years (HR 0.82; 95% CI ; p=0.002)

19 = CABG = PCI 4 years = CABG 16.4% PCI 20.8% Comparative Effectiveness of Revascularization Strategies William S. Weintraub, M.D., et al. N Engl J Med 2012; 366: years old : 2-3VD ASCERT STUDY (registre) Chirurgie vs PCI: + 25% survie

20 10080pts matched patients RCT %CABG vs 72 % PCI 5 years all-cause mortality hazard ratio [HR] of 0.92 (95% CI ) C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

21 PCI is not effective as CABG in DIABETICS in real world 2766 risk matched DIABETICS: PCI 5 yr mortality x 2 4 JACC 2001 JACC yr survival: 58% for CABG vs 45% for PCI (p=0.02) CIRC yr mortality in 601 DM pts: 3% CABG vs 12%-18% PCI/DES (p<0.001)

22 Chirurgie Angioplastie TriTC & Diabétiques C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

23 Angor stable

24 Registres / Etudes Randomisées CABG vs PCI actuel 2013 SYNTAX

25 Registre SYNTAX SYNTAX score élevé / pts non randomisés Chirurgie diminution mortalité, IDM, MACCE C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

26 SYNTAX à 5 ans C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

27 SYNTAX à 5 ans Différence de Mortalité cardiaque en faveur de la chirurgie Moins IDM et de MACCE pour la chirurgie C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

28 SYNTAX Score intermédiaire CABG PCI C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

29 SYNTAX Score élevé CABG PCI C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

30 Multivessel Disease CABG vs PCI

31 SYNTAX CABG PCI C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

32 SYNTAX 5 years results TVD Real patients Previous 19 trials extremely selected patients 80% TVD have a 79% 5 year survival Only 20% of TVD low risk equal survival PCI = CABG

33 Left Main Stenosis

34 Target Vessel Revascularisation: DES vs CABG Seung et al. N Engl J Med 2008;358: C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

35 SYNTAX CABG PCI C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

36 Diabétiques

37 Diabétiques CABG PCI C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

38 FREEDOM TRIAL SCREENING & ENROLLMENT 32,966 Patients were screened for eligibility 40% ont refusé le PAC 3,309 were eligible (10%) 1,409 did not consent 1,900 consented (57%) 953 Randomized to PCI/DES* 5 underwent CABG 3 withdrew prior to procedure 3 died prior to procedure 3 underwent neither PCI/DES or CABG 947 Randomized to CABG 18 underwent PCI/DES 26 withdrew prior to procedure 3 died prior to procedure 7 underwent neither PCI/DES or CABG 16 withdrew post-procedure 43 were lost to follow-up 36 withdrew post-procedure 51 were lost to follow-up *953 and 947 included ITT analysis using all available follow-up time post-randomization

39 FREEDOM PRIMARY OUTCOME DEATH / STROKE / MI Death/Stroke/MI, % 30 PCI/DES CABG Logrank P= PCI/DES CABG Year Event Rates: 26.6% vs. 18.7% Years post-randomization PCI/DES N CABG N s

40 Freedom from Event (%) Freedom from Event (%) Freedom from Event (%) FREEDOM PRIMARY ENDPOINT DEATH / STROKE / MI TREATMENT / SYNTAX INTERACTION - p= SYNTAX Score 22 (N=669) 5-Year Event Rates: 23.2% 17.2% PCI/DES CABG SYNTAX Score (N=844) 5-Year Event Rates: 27.2% 17.7% PCI/DES CABG Years post-randomization Years post-randomization SYNTAX Score 33 (N=374) 5-Year Event Rates: 30.6% 22.8% PCI/DES CABG Years post-randomization

41 Pontage coronaire est ce la fin de l histoire? (SYNTAX, FREEDOM) C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

42 Stents biorésorbables

43 Programme clinique Stents biorésorbables

44 L après FREEDOM = Stents biorésorbables SCAAR registry ( consecutive stent procedures) 2 ème génération stent réduction de 23% à 2 ans COMPARE II trial (biolimus BDS vs everolimus Stent) SORT OUT V ( pts enrôlés dans des RCT) biolimus-eluting Nobori stent DES cypher stents NOBORI 2 registry = Faible taux de thrombose à long terme 0,1% à 1-2 ans ISAR-TEST 6 trial (n=2010) vérifie ces résultats C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

45 Fin du débat? Non C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

46 La Chirurgie coronaire reste t elle le Gold Standard de la revascularisation myocardique? OUI Chirurgie 1967 Medical Angioplastie 1979 C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013

47 Conclusion La chirurgie reste le Gold Standard: Lésions tritronculaires Syntax score > 23 Patients diabétiques traités médicalement Échec ou impossibilité d angioplasties (registre/ vraie vie) L industrie et les patients favorisent l angioplastie C o n g r è s d e C h i r u r g i e T h o r a c i q u e e t C a r d i o - V a s c u l a i r e - M a r s e i l l e 1 2 / 1 5 j u i n 2013