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 CABG N=348 TAXUS N=357 P value Age *, mean ± SD (y)65.6 ± ± Medically treated diabetes *, % BMI, mean ± SD27.7 ± ± Additive euroSCORE *, mean ± SD3.9 ± ± Total Parsonnet score *, mean ± SD9.1 ± ± Total SYNTAX Score, mean ± SD26.7 ± ± No. lesions, mean ± SD3.2 ± ± Core laboratory reported unless * Site-reported

ITT population P= % 0 Months Since Allocation Cumulative Event Rate (%) Before 1 year * 4.5% vs 4.2% P= years * 1.9% vs 1.5% P= years * 2.3% vs 1.8% P= years * 3.0% vs 4.3% P= % 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

ITT population P= % 0 Months Since Allocation Cumulative Event Rate (%) Before 1 year * 4.2% vs 4.2% P= years * 0.0% vs 1.2% P= years * 0.0% vs 1.5% P= years * 0.7% vs 0.3% P= % 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

ITT population P= % 0 Months Since Allocation Cumulative Event Rate (%) Before 1 year * 2.7% vs 0.3% P= years * 0.9% vs 0.6% P= years * 0.3% vs 0.3% P= years * 0.3% vs 0.3% P= % 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

ITT population P= % 0 Cumulative Event Rate (%) Months Since Allocation Before 1 year * 6.5% vs 11.8% P= years * 5.0% vs 8.2% P= years * 2.6% vs 3.9% P= years * 3.0% vs 4.0% P= % 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

P= % 0 Cumulative Event Rate (%) Months Since Allocation ITT population Before 1 year * 13.7% vs 15.8% P= years * 7.5% vs 10.3% P= years * 5.2% vs 5.7% P= years * 6.4% vs 8.3% P= % 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

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

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 (%) Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P value > > > < < 48

Left Main TAXUS (N=135) CABG (N=149) MACCE to 4 Years by SYNTAX Score Tercile High Scores (  33) P< % 26.3% Months Since Allocation Cumulative Event Rate (%) 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

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

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 Low ≤22 CABG 45% PCI 55%

Mais …

Autres études randomisées

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

PRECOMBAT Trial Subgroup Analysis Park SJ, ACC 11

Autre stent ?

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

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).

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

LEMAX and TAXUS LM french registries P. Garot AHA 2011

Moins de stents ?

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

French CABG N=105 non-French CABG N=792 French TAXUS N=103 non-French TAXUS N=800 Age, mean ± SD (y)65.8 ± ± ± ± 9.5 Male, % BMI, mean ± SD26.9 ± ± ± ± 4.8 Medically-treated Diabetes, % Hypertension, % Hyperlipidemia, % Current smoker, % Prior MI, % Unstable angina, % Additive euroSCORE, mean ± SD3.7 ± ± ± ± 2.6 Total Parsonnet score, mean ± SD8.7 ± ± ± ± 6.9 Site-reported data Patient Characteristics French vs non-French Subsets

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

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

Linear Increase in MACCE by Number of Stents in the SYNTAX Trial 12m MACCE in TAXUS Arm 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%

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

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;

Stenting technique and MACE rate A meta-analysis on 1,274 patients with DES for ULM disease Rate of complex stenting technique (%) ,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

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; ;

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