1. Lésion du tronc commun : reste-t-il une place pour la chirurgie ? La vision de l’angioplasticien Y. Louvard, ICPS, Massy

2. SYNTAX

3. Patient Characteristics LM Subset CABG N=348 TAXUS N=357 P value Age *, mean ± SD (y)65.6 ± 10.1 65.4 ± 9.8 0.78 Medically treated diabetes *, %22.421.80.86 BMI, mean ± SD27.7 ± 5.0 28.2 ± 4.9 0.24 Additive euroSCORE *, mean ± SD3.9 ± 2.9 3.9 ± 2.8 0.91 Total Parsonnet score *, mean ± SD9.1 ± 7.4 8.9 ± 7.8 0.77 Total SYNTAX Score, mean ± SD26.7 ± 11.5 28.1 ± 12.4 0.13 No. lesions, mean ± SD3.2 ± 1.9 3.3 ± 1.8 0.89 Core laboratory reported unless * Site-reported

4. ITT population P=0.94 11.2% 0 Months Since Allocation Cumulative Event Rate (%) 25 50 Before 1 year * 4.5% vs 4.2% P=0.88 1-2 years * 1.9% vs 1.5% P=0.68 2-3 years * 2.3% vs 1.8% P=0.67 3-4 years * 3.0% vs 4.3% P=0.39 012482436 11.4% All-Cause Death to 4 Years Left Main Subset TAXUS (N=357) CABG (N=348) Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates

5. ITT population P=0.20 4.8% 0 Months Since Allocation Cumulative Event Rate (%) 25 50 012482436 Before 1 year * 4.2% vs 4.2% P=0.97 1-2 years * 0.0% vs 1.2% P=0.12 2-3 years * 0.0% vs 1.5% P=0.06 3-4 years * 0.7% vs 0.3% P=0.61 7.2% Myocardial Infarction to 4 Years Left Main Subset TAXUS (N=357) CABG (N=348) Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates

6. ITT population P=0.03 4.3% 0 Months Since Allocation Cumulative Event Rate (%) 25 50 012482436 Before 1 year * 2.7% vs 0.3% P=0.009 1-2 years * 0.9% vs 0.6% P=0.68 2-3 years * 0.3% vs 0.3% P=1.00 3-4 years * 0.3% vs 0.3% P=1.00 1.5% CVA to 4 Years Left Main Subset TAXUS (N=357) CABG (N=348) Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates

7. ITT population P=0.003 14.6% 0 Cumulative Event Rate (%) 25 50 Months Since Allocation 012482436 Before 1 year * 6.5% vs 11.8% P=0.02 1-2 years * 5.0% vs 8.2% P=0.10 2-3 years * 2.6% vs 3.9% P=0.36 3-4 years * 3.0% vs 4.0% P=0.50 23.5% TAXUS (N=357) CABG (N=348) Repeat Revascularization to 4 Years Left Main Subset Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates

8. P=0.14 27.8% 0 Cumulative Event Rate (%) 25 50 Months Since Allocation ITT population 012482436 Before 1 year * 13.7% vs 15.8% P=0.44 1-2 years * 7.5% vs 10.3% P=0.22 2-3 years * 5.2% vs 5.7% P=0.78 3-4 years * 6.4% vs 8.3% P=0.35 33.2% TAXUS (N=357) CABG (N=348) MACCE to 4 Years Left Main Subset Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates

9. ITT population (n=705)(n=91)(n=138)(n=218)(n=258) P=0.14P=0.55P=0.54P=0.12P=0.14 MACCE to 4 Years Left Main Subsets ITT population Cumulative KM Event Rate; log-rank P value Patients (%) TAXUS CABG

10. CABGPCIP value Death11.8%7.5%0.12 CVA3.9%1.4%0.11 MI3.8%5.1%0.55 Death, CVA or MI17.1%13.5%0.25 Revasc.16.9%19.1%0.57 Months Since Allocation Cumulative Event Rate (%) P=0.65 Left Main TAXUS (N=221) CABG (N=196) MACCE to 4 Years by SYNTAX Score Tercile Low to Intermediate Scores (0-32) 27.6% 29.0% Months Since Allocation Cumulative Event Rate (%) 01224 40 0 20 30 10 36 Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P value > > > < < 48

11. Left Main TAXUS (N=135) CABG (N=149) MACCE to 4 Years by SYNTAX Score Tercile High Scores (  33) P<0.003 42.6% 26.3% Months Since Allocation Cumulative Event Rate (%) 01224 50 0 25 4836 Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P valueCABGPCIP value Death10.5%17.9%0.06 CVA4.9%1.6%0.14 MI6.1%10.9%0.18 Death, CVA or MI18.5%23.1%0.33 Revasc.11.8%31.3%<0.001

12. Lésion du tronc commun : reste-t-il une place pour la chirurgie ? Oui: 45% ?

13. SYNTAX Trial Patient Distribution LM Patients LM CABG Registry (N=302) LM PCI Registry (N=76) LM RCT Patients (N=705) SYNTAX Scores High ≥33 Intermediate 23-32 Low ≤22 CABG 45% PCI 55%

14. Mais …

15. Autres études randomisées

17. PRECOMBAT Trial Death, MI or Stroke Park SJ, ACC 11

18. PRECOMBAT Trial Subgroup Analysis Park SJ, ACC 11

19. Autre stent ?

21. Outcomes from randomised trials comparing EES with PES Claessen, Stone,Neth Heart J 2010;18:451-3

22. Would Syntax have been a positive trial if Xience V had been use instead of Taxus ? In SYNTAX, PCI would have been non-inferior to CABG if the 95% upper limit of the confidence interval (CI) for the difference in MACCE was below the prespecified delta of 6.6%. A hypothetical reduction of 2.2% in one-year MACCE (20 events/891 patients) would reduce the MACCE rate for PCI to 15.6%. This would have resulted in non-inferiority (absolute difference in MACCE 3.2%, 95% CI 0.0 to 6.5%). The use of EES might have led to a total reduction of approximately 81 events in the PCI group (hypothetical relative reductions of 51% in repeat intervention and 43% in MI).

23. 2,500 selected patients with left main disease Randomized for PCI with Xience V vs CABG Primary endpoint: Death, MI or stroke at 3 years Secondary endpoint: Death, MI, stroke or unplanned repeat revascularization. Cost-effectiveness and quality of life EXCEL

24. LEMAX and TAXUS LM french registries P. Garot AHA 2011

25. Moins de stents ?

26. Clinical SYNTAX Sites in France Centre Hôpital Universitaire Rouen/Hôpital Charles Nicolle; Rouen –CABG Bessou; PCI Eltchaninoff Clinique Saint-Hilaire Rouen; Rouen –CABG Bessou; PCI Berland Institut Jacques Cartier; Massy –CABG Farge; PCI Morice Clinique St Augustin; Bordeaux –CABG Fernandez; PCI Darremont Centre Hôpital Universitaire Rangueil; Toulouse –CABG Fournial; PCI Carrié Clinique Pasteur; Toulouse –CABG Soula; PCI Marco/Fajadet

27. French CABG N=105 non-French CABG N=792 French TAXUS N=103 non-French TAXUS N=800 Age, mean ± SD (y)65.8 ± 10.864.9 ± 9.766.1 ± 10.765.1 ± 9.5 Male, %85.778.080.675.9 BMI, mean ± SD26.9 ± 4.628.0 ± 4.527.4 ± 4.728.2 ± 4.8 Medically-treated Diabetes, %25.724.523.325.9 Hypertension, %71.277.864.775.2 Hyperlipidemia, %71.278.079.478.6 Current smoker, %20.022.320.418.3 Prior MI, %20.035.725.232.8 Unstable angina, %29.527.845.626.8 Additive euroSCORE, mean ± SD3.7 ± 2.93.8 ± 2.74.2 ± 2.53.7 ± 2.6 Total Parsonnet score, mean ± SD8.7 ± 7.98.4 ± 6.78.8 ± 7.68.5 ± 6.9 Site-reported data Patient Characteristics French vs non-French Subsets

28. Outcome According to Geographic Location at 3 Years French Subset n=208 non-French n=1592 TAXUS CABG Patients (%) TAXUS CABG

29. Patient-based French TAXUS N=103 non - French TAXUS N=800 Staged procedure, %6.915.1 Post-Proced. Hospital Stay, mean ± SD (d) 2.9  3.53.4  4.6 No. stents implanted, mean ± SD 4.2  2.14.7  2.3 Total length implanted, mm ± SD 75.2  41.587.6  48.5 Range, mm12 – 2048 – 324 Long stenting (>100 mm), %22.834.5 Procedural Characteristics French vs non-French Subsets: PCI RCT

30. Linear Increase in MACCE by Number of Stents in the SYNTAX Trial 12m MACCE in TAXUS Arm 12345678+ Number of Stents Implanted 12m MACCE Probability 12m MACCE Rate 4.6 Stents SYNTAX Average 17.8% 1.5 Stents “Typical” Real World Average 1 stent 5.6% Avg. in pts with 5-8+ stents in SYNTAX 19.6%

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

33. Functional SYNTAX score for risk assesment in multivessel CAD Predictors for composites of death, MI, repeat PCI or CABG at 1 year Nam, JACC 2011;58;1211-1218

34. Stenting technique and MACE rate A meta-analysis on 1,274 patients with DES for ULM disease Rate of complex stenting technique (%) 10080604020 0 -,2 -,4 -,6 -,8 -1,0 -1,2 -1,4 De Lezo Christiansen Agostoni Lee Sheiban Park Han Carrié Palmerini Chieffo Migliorini Price Dudek P=0.050 Risk of MACE at follow-up (Log10 of the actual rate) ←Lower risk Higher risk → Patients treated with 2 stents are significantly more likely to have MACE I. Sheiban, EBC 2008 ULM Metaanalysis

35. 3Y Outcomes After SES Implantation for ULM Coronary Artery Disease: Insights From the j-Cypher Registry Cardiac death (A) and TLR (B) in pts treated for ULMCA / distal bifurcation stenting strategy Toyofuku Circulation 2009;120;1866-1874;

36. Lésion du tronc commun : reste-t-il une place pour la chirurgie ? TC + tritronc. (SYNTAX) : 36,6 % ? TC + tritronc. « fonctionnel »: ? FFR = 30% de stents en moins (FAME): - 3% de MACE ? (non inferiorité dans SYNTAX) Strategie provisionnelle dans le TC: ? Stent 2 ieme génération: Syntax > 32 = Syntax < 18 ? 0% ? EXCEL, NOBLE