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Patrick W. Serruys MD PhD Friedrich W. Mohr MD PhD On behalf of the SYNTAX investigators

The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study Primary Endpoint Results at One Year in the Randomized Cohort. Patrick W. Serruys MD PhD Friedrich W. Mohr MD PhD On behalf of the SYNTAX investigators. Conflicts of Interest: None.

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Patrick W. Serruys MD PhD Friedrich W. Mohr MD PhD On behalf of the SYNTAX investigators

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  1. The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery:The SYNTAX StudyPrimary Endpoint Results at One Year in the Randomized Cohort Patrick W. Serruys MD PhD Friedrich W. Mohr MD PhD On behalf of the SYNTAX investigators Conflicts of Interest: None

  2. Background: I • During the present decade, major developments in CABG (e.g. off-pump technique, less invasive approach, increased arterial revascularization and optimal perioperative care). • In PCI (e.g. improved technique, stent design, guide wires, anti-platelet therapy, and drug-eluting stents) have made it important to reassess the respective values of the two revascularization techniques in an all-comers population as seen by the surgeon and the interventional cardiologist in their daily practice.

  3. Background: II • At the time of the trial design (in 2003-2004), a retrospective website survey of 104 medical centers over a period of 3 months showed that 12,072 patients (1/3 LM, 2/3 3VD) were revascularized by surgery (2/3) or by PCI (1/3). • The SYNTAX randomized trial is an attempt to provide an evidence-base to determine whether this approach, which is already currently practiced, is valid. Kappetein et al, Eur J Cardiothorac Surg. 2006;29:486-491

  4. SYNTAX: Intended All-Comers Design with Nested Registries • Intended all-comers study design instead of a highly selected patient population • Consensus physician agreement (surgeon & cardiologist) instead of inclusion & exclusion criteria • And, nested registries for CABG only and PCI only to define patient characteristics and outcomes of these two unique treatment options

  5. SYNTAX Eligible Patients De novo disease • Limited Exclusion Criteria • Previous interventions • Acute MI with CPK>2x • Concomitant cardiac surgery Left Main Disease (isolated, +1, +2 or +3 vessels) 3 Vessel Disease (revasc all 3 vascular territories)

  6. Patient Profiling Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to : Patient’s operative risk (EuroSCORE & Parsonnet score) Coronary lesion complexity (Newly developed SYNTAX score) Goal: SYNTAX score to provide guidance on optimal revascularization strategies for patients with high risk lesions No. & Location of lesion Dominance Left Main SYNTAX SCORE Calcification Thrombus 3 Vessel Bifurcation CTO Tortuosity • BARI classification of coronary segments • Leaman score, Circ 1981;63:285-299 • Lesions classification ACC/AHA , Circ 2001;103:3019-3041 • Bifurcation classification, CCI 2000;49:274-283 • CTO classification, J Am Coll Cardiol 1997;30:649-656 Sianos et al, EuroIntervention 2005;1:219-227 Valgimigli et al, Am J Cardiol 2007;99:1072-1081 Serruys et al, EuroIntervention 2007;3:450-459

  7. There is ‘3-vessel disease’ and ‘3-vessel disease’ LM 99% LAD 70-90% RCA2 70-90% Patient 1 Patient 2 LCx 70-90% LAD 99% LCx 100% SYNTAX SCORE 52 SYNTAX SCORE 21 Patient 1 Patient 2 RCA3 70-90% RCA 100%

  8. SYNTAX Trial Design + 62 EU Sites 23 US Sites Heart Team (surgeon & interventionalist) All Pts with de novo 3VD and/or LM disease (N=4,337) Total enrollment N=3075 Amenable for both treatment options Amenable for only one treatment approach • Treatment preference (9.4%) • Referring MD or pts. refused informed consent (7.0%) • Inclusion/exclusion (4.7%) • Withdrew before consent (4.3%) • Other (1.8%) • Medical treatment (1.2%) Stratification: LM and Diabetes DM 28.2% NonDM 71.8% Stratification: LM and Diabetes DM 28.5% Non DM 71.5% Randomized Arms N=1800 Two Registry Arms N=1275 Randomized Arms n=1800 Two Registry Arms PCI N=198 PCI all captured w/ follow up CABG N=1077 CABG n=1077 CABG 2500 750 w/ f/u CABG n=897 TAXUS n=903 PCI n=198 TAXUS* N=903 vs CABG N=897 no f/u n=428 5yr f/u n=649 71% enrolled (N=3,075) vs LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4% *TAXUS Express

  9. SYNTAX Primary EndpointRandomized trial The primary clinical endpoint is the 12 Month major Cardiovascular or Cerebrovascular event rate (MACCE *) MACCE is defined as: All cause Death Cerebrovascular Accident (CVA/Stroke) Documented Myocardial Infarction (ARC definition) Any Repeat Revascularization (PCI and/or CABG) All events CEC Adjudicated *ARC MACCE definition Circ 2007; 115:2344-2351

  10. Primary Endpoint (12 Month MACCE)Non-inferiority to CABG Difference in MACCE rates Upper 1-sided 95% confidence intervals Zone of Non-inferiority Pre-specified Margin = 6.6% Non-inferior Non-inferior Inferior Inferior -4% -2% 0 2% 4% 6% 8% 10% Difference in MACCE rates (CABG-PCI with TAXUS Express) Piaggio et al, JAMA 2006; 295: 1152-1160

  11. SYNTAX Methodology Monitoring Data Monitoring Committee • 100% randomized20% registries • S. Pocock (Chair)J-P. BassandT. Clayton • D.P. FaxonB.J. Gersh • J.L. Monro • M.I. Turina Steering Committee P.W. Serruys (PI) F.W. Mohr (PI) M-C. Morice (Co-PI) A.P. Kappetein (Co-PI) A. Colombo K.D. Dawkins T.E. Feldman D.R. Holmes M.J. Mack J.L. Pomar E. Stahle M. vd Brand Clinical Events Committee P.G.Steg (Chair)D. BirnbaumT.P. CarrelM. Gorman C. HanetO.M. HessE.W.L. JansenL.J.Kappelle Core Laboratory • Blood & Biochemistry: • Covance • ECG: Cardialysis • QCA: Cardialysis

  12. Top 30 Enrolling Centers: I Austria Czech Rep Norway France Germany Hungary Italy

  13. Top 30 Enrolling Centers: II Italy Latvia Netherlands Poland Sweden UK US

  14. Patient Characteristics (l)Randomized Cohort

  15. Patient Characteristics (II)Randomized Cohort

  16. Procedural CharacteristicsPCI Randomized Cohort TAXUSN=903 Patient-based

  17. Procedural CharacteristicsCABG Randomized Cohort

  18. TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation All-Cause Death to 12 Months P=0.37* 4.3% 3.5% Event Rate ± 1.5 SE. *Fisher’s Exact Test ITT population

  19. CVA to 12 Months TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.003* 2.2% 0.6% Event Rate ± 1.5 SE. *Fisher’s Exact Test ITT population

  20. Myocardial Infarction to 12 Months TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.11* 4.8% 3.2% Event Rate ± 1.5 SE. *Fisher’s Exact Test ITT population

  21. All-Cause Death/CVA/MI to 12 Months TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.98* 7.7% 7.6% Event Rate ± 1.5 SE. *Fisher’s Exact Test ITT population

  22. Symptomatic Graft Occlusion & Stent Thrombosis to 12 Months TAXUS(N=903) CABG(N=897) P=0.89 Patients (%) 3.4 3.3 n=27 n=28 CABG TAXUS ITT population

  23. Repeat Revascularization to 12 Months TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P<0.0001* 13.7% 5.9% Event Rate ± 1.5 SE. *Fisher’s Exact Test ITT population

  24. MACCE to 12 Months TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.0015* 17.8% 12.1% Event Rate ± 1.5 SE. *Fisher’s Exact Test ITT population

  25. Primary Endpoint: 12 Month MACCE Non-inferiority analysis Pre-specified Margin = 6.6% +95% CI = 8.3% 5.5% 0 5% 10% 15% 20% Difference in MACCE The criteria for non-inferiority comparison was not met for the primary endpoint, further comparisons for the LM and 3VD subgroups are observational only and hypothesis generating

  26. CABG TAXUS Left Main Isolated Left Main + 3VD N=91 (13%) Left Main + 1VD N=258 (37%) N=138 (20%) Left Main + 2VD N=218 (31%) 12 Month LM Subgroup MACCE Rates Patients (%) All LMN=705

  27. CABG TAXUS 12 Month LM Subgroup MACCE Rates Patients (%) LM isolatedN=91 All LMN=705

  28. CABG TAXUS 12 Month LM Subgroup MACCE Rates Patients (%) LM+1VDN=138 All LMN=705 LM isolatedN=91

  29. CABG TAXUS 12 Month LM Subgroup MACCE Rates Patients (%) LM+2VDN=218 All LMN=705 LM isolatedN=91 LM+1VDN=138

  30. CABG TAXUS 12 Month LM Subgroup MACCE Rates Patients (%) LM+3VD N=258 All LMN=705 LM isolatedN=91 LM+1VDN=138 LM+2VDN=218

  31. CABG TAXUS 12 Month Subgroup MACCE Rates Patients (%) 3VD (All) N=1095 LM+3VD N=258 All LMN=705 LM isolatedN=91 LM+1VDN=138 LM+2VDN=218

  32. Outcome according to Diabetic Status CABG TAXUS P=0.0025 P=0.96 P=0.08 P=0.97 MACCE Death/CVA/MI MACCE Death/CVA/MI Non-Diabetic N=1348 Diabetes (Medical Treatment) N=452

  33. Conclusions: In the randomized SYNTAX cohort, there were comparable overall safety outcomes (Death, CVA, MI,) in CABG and PCI patients at 12 months (7.7 vs. 7.6 %). There was a significantly higher rate of revascularization in the PCI group (13.7 vs. 5.9 %), and a significantly higher rate of CVA in the CABG group (2.2 vs. 0.6 %). Overall MACCE in the PCI group was higher (17.8 vs.12.1 %) due to an excess of redo revascularization compared with CABG. Per protocol rates of symptomatic graft occlusion and stent thrombosis were similar. The SYNTAX score will help stratify patients for the appropriate revascularization option.

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