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Lésion du tronc commun : reste-t-il une place pour la chirurgie ? La vision de l’angioplasticien

Lésion du tronc commun : reste-t-il une place pour la chirurgie ? La vision de l’angioplasticien . Y. Louvard, ICPS, Massy. SYNTAX. Patient Characteristics LM Subset. Core laboratory reported unless * Site-reported. TAXUS (N=357). CABG (N=348). 50. 25. 0. 12. 24. 36. 48.

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Lésion du tronc commun : reste-t-il une place pour la chirurgie ? La vision de l’angioplasticien

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  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 CharacteristicsLM Subset Core laboratory reported unless *Site-reported

  4. TAXUS(N=357) CABG(N=348) 50 25 0 12 24 36 48 All-Cause Death to 4 Years Left Main Subset 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 P=0.94 Cumulative Event Rate (%) 11.4% 11.2% 0 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population

  5. TAXUS(N=357) CABG(N=348) 50 25 0 12 24 36 48 Myocardial Infarction to 4 Years Left Main Subset 2-3 years* 0.0% vs 1.5% P=0.06 Before 1 year* 4.2%vs 4.2% P=0.97 1-2 years* 0.0% vs 1.2% P=0.12 3-4 years* 0.7% vs 0.3% P=0.61 P=0.20 Cumulative Event Rate (%) 7.2% 4.8% 0 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population

  6. TAXUS(N=357) CABG(N=348) 50 25 0 12 24 36 48 CVA to 4 Years Left Main Subset 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 P=0.03 Cumulative Event Rate (%) 4.3% 1.5% 0 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population

  7. TAXUS(N=357) CABG(N=348) 50 25 0 12 24 36 48 Repeat Revascularization to 4 Years Left Main Subset 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 P=0.003 23.5% Cumulative Event Rate (%) 14.6% 0 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population

  8. TAXUS(N=357) CABG(N=348) 50 25 0 12 24 36 48 MACCE to 4 Years Left Main Subset 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 P=0.14 33.2% Cumulative Event Rate (%) 27.8% 0 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population

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

  10. MACCE to 4 Years by SYNTAX Score Tercile Low to Intermediate Scores (0-32) CABG(N=196) TAXUS(N=221) Left Main > 40 29.0% > 30 P=0.65 < Cumulative Event Rate (%) Cumulative Event Rate (%) 20 27.6% 10 > 0 < 0 12 24 36 48 Months Since Allocation Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

  11. MACCE to 4 Years by SYNTAX Score Tercile High Scores (33) CABG(N=149) TAXUS(N=135) 50 Cumulative Event Rate (%) 25 0 0 12 24 36 48 Months Since Allocation Left Main 42.6% P<0.003 26.3% Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

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

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

  14. Mais …

  15. Autres études randomisées

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

  17. PRECOMBAT Trial Subgroup Analysis Park SJ, ACC 11

  18. Autre stent ?

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

  20. 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).

  21. EXCEL 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

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

  23. Moins de stents ?

  24. 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

  25. Patient Characteristics French vs non-French Subsets Site-reported data

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

  27. Procedural CharacteristicsFrench vs non-French Subsets: PCI RCT

  28. Linear Increase in MACCE by Number of Stentsin the SYNTAX Trial 1.5 Stents“Typical” Real World Average Avg. in pts with 5-8+ stents in SYNTAX19.6% 4.6 StentsSYNTAX Average 17.8% 1 stent 5.6% 12m MACCE Probability 12m MACCE Rate 12m MACCE in TAXUS Arm 1 2 3 4 5 6 7 8+ Number of Stents Implanted

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

  30. 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

  31. Stenting technique and MACE rateA meta-analysis on 1,274 patients with DES for ULM disease ULM Metaanalysis -,2 P=0.050 Price -,4 Chieffo Palmerini -,6 Migliorini Risk of MACE at follow-up (Log10 of the actual rate) ←Lower risk Higher risk→ Dudek -,8 Agostoni Carrié Lee -1,0 Han Park Sheiban Christiansen -1,2 De Lezo -1,4 0 20 40 60 80 100 Rate of complex stenting technique (%) Patients treated with 2 stents are significantly more likely to have MACE I. Sheiban, EBC 2008

  32. 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;

  33. 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 2ieme génération: Syntax > 32 = Syntax < 18 ? 0% ? • EXCEL, NOBLE Lésion du tronc commun : reste-t-il une place pour la chirurgie ?

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