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SYNTAX - Top 30 Enrolling Centers: I

SYNTAX - Top 30 Enrolling Centers: I. Austria. Czech Rep. Norway. France. Germany. Hungary. Italy. SYNTAX - Top 30 Enrolling Centers: II. Italy. Latvia. Netherlands. Poland. Sweden. UK. US. SYNTAX. Heart team meeting

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SYNTAX - Top 30 Enrolling Centers: I

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  1. SYNTAX - Top 30 Enrolling Centers: I Austria Czech Rep Norway France Germany Hungary Italy

  2. SYNTAX - Top 30 Enrolling Centers: II Italy Latvia Netherlands Poland Sweden UK US

  3. SYNTAX Heart team meeting - surgeon(s) and interventional cardiologist(s) assess each patient Operative risk (EuroSCORE & Parsonnet score) Coronary lesion complexity (SYNTAX score) 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

  4. SYNTAX Trial- Eligible Patients Isolated left main 3-vessel disease left main + 1-vessel disease Revascularisation in all 3 vascular territories left main + 2-vessel disease left main + 3-vessel disease De novo disease • Limited Exclusion Criteria • Previous interventions (PCI or CABG) • Acute MI with CPK>2x • Concomitant cardiac surgery

  5. SYNTAX Trial Design + 62 EU Sites 23 US Sites All Pts with de novo 3VD and/or LM disease (N=4,337) • Treatment preference (9.4%) • Referring doctor or patient refused informed consent (7.0%) • Inclusion/exclusion (4.7%) • Withdrew before consent (4.3%) • Other (1.8%) • Medical treatment (1.2%) 71% enrolled (N=3,075)

  6. SYNTAX Trial Design + 62 EU Sites 23 US Sites Heart Team (surgeon & interventionalist) Total enrollment N=3075 Amenable for both treatment options Amenable for only one treatment approach Stratification: LM and Diabetes Stratification: LM and Diabetes Randomised Arms n=1800 Two Registry Arms 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 vs LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4%

  7. 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% Randomised Arms n=1800 Two Registry Arms 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%

  8. Randomised Patient Flow (ITT) Total randomized N=1800 CABG897 (49.8%) TAXUS*903 (50.2%) 408 Withdrawn 47Lost to FU 13 75 12 mo Follow upN=1740 (96.7%) CABG849 (94.6%) TAXUS*891 (98.7%)

  9. Patient Characteristics (l)Randomised Cohort

  10. Patient Characteristics (lI)Randomised Cohort

  11. Baseline Characteristics in DES PatientsSYNTAX Trial Versus 2 Large, Multicenter MVD Registries *Creatinine >220µmol/liter for NY State, >200µmol/liter for the SYNTAX trial

  12. Procedural CharacteristicsPCI Randomised Cohort

  13. Procedural CharacteristicsCABG Randomised Cohort

  14. Procedural CharacteristicsRandomised Cohort ‡ Per protocol: ‘Complete revascularisation is defined as the treatment of any lesion with more than 50% diameter stenosis in vessels  1.5 mmdiameter as estimated on the diagnostic angiogram during the local Heart Team conference’. Completeness of revascularization was assessed post procedure by the operator (Surgeon or Interventional Cardiologist) *Allocation to procedure †For PCI patients, includes time for staged procedure

  15. CABG(N=897) TAXUS*(N=903) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation SYNTAX - All-cause mortality to 12 Months P=0.37¥ 4.3% 3.5% ITT; ¥Fisher Exact Test

  16. SYNTAX - Cerebrovascular Events to 12 Months CABG(N=897) TAXUS*(N=903) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.003¥ 2.2% 0.6% ITT; ¥Fisher Exact Test

  17. SYNTAX - Myocardial Infarction to 12 Months CABG(N=897) TAXUS*(N=903) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.11¥ 4.8% 3.2% ITT; ¥Fisher Exact Test

  18. SYNTAX - Death/CVA/MI to 12 Months CABG(N=897) TAXUS*(N=903) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.98¥ 7.6% 7.7% ITT; ¥Fisher Exact Test

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

  20. SYNTAX - Repeat Revascularisation to 12 Months CABG(N=897) TAXUS*(N=903) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P<0.0001¥ 13.7% 5.9% ITT; ¥Fisher Exact Test

  21. SYNTAX - MACCE to 12 Months CABG(N=897) TAXUS*(N=903) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.0015¥ 17.8% 12.1% ITT; ¥Fisher Exact Test

  22. SYNTAX - 12 Month Clinical Event Rates TAXUS*(N=903) CABG(N=897) 4.3 All Death 3.5 P=0.37 CVA 2.2 0.6 P=0.003 MI 3.2 4.8 P=0.11 Death/MI/CVA 7.7 7.6 P=0.98 Revascularisation 5.9 13.7 P<0.0001 Patients (%) ITT, Kaplan-Meier Rates; Fisher Exact Test

  23. 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 Non-inferiority comparison was not met for the primary endpoint, further comparisons for the LM and 3VD subgroups are observational only and hypothesis generating

  24. Stent Number and Length Higher in the SYNTAX Trial 48% of patients received ≥5 stents Max # 14 stents! Multivessel disease: 96.2%* 3-vessel disease: 90.8% Avg. stents per patient: 4.6 ± 2.3 Avg. stented length: 86.1 mm Patients (%) Total Number of Stents Implanted per Patient *3VD+LM/3VD+LM/2VD+LM/1VD

  25. Average Number of Stents Implanted per Patient SYNTAX Trial Average number of stents implanted in SYNTAX is higher than any other contemporary DES versus CABG study 4.6±2.3 SYNTAX

  26. Average Total Stented Length SYNTAX Trial 86.1±47.9 Average total stent length (mm) SYNTAX

  27. 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

  28. SYNTAX - 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

  29. 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%) SYNTAX - Left Main Subgroup MACCE Rates at 12 Months Patients (%) All LMN=705

  30. SYNTAX - Left Main and Three Vessel Disease Subgroup MACCE Rates at 12 Months CABG TAXUS* Patients (%) All LMN=705 LM+1VDN=138 LM+2VDN=218 LM+3VD N=258 3VD ( w/o LM) N=1095 LM IsolatedN=91

  31. Contemporary studies of DES versus CABG1-Year Mortality in CABG Arm Multivessel Left Main Patients (%) Multivessel and/or Left Main SYNTAX Trial (n=897) Javaid 2008(n=505) Yang2008(n=390) ARTS I(n=602) Lee, 2007(n=103) Sanmartin 2007(n=245) Palmerini 2006(n=154) Lee 2006(n=123) Chieffo 2006(n=142)

  32. Contemporary studies of DES versus CABG1-Year TVR (PCI or CABG) in CABG Arm Multivessel Left Main Multivessel and/or Left Main Patients (%) SYNTAX Trial (n=897) Yang2008(n=390) ARTS I(n=602) Lee 2007(n=103) Sanmartin 2007(n=245) Palmerini 2006(n=154) Lee 2006(n=123) Chieffo 2006(n=142)

  33. Contemporary studies of DES versus CABG1-Year Stroke Rates in CABG Arm Multivessel Left Main Multivessel and/or Left Main Patients (%) SYNTAX Trial (n=897) Yang2008(n=390) ARTS I(n=602) Lee 2007(n=103) Javaid 2008(n=505) Sanmartin 2007(n=245) Chieffo 2006(n=142)

  34. Contemporary studies of DES versus CABG1-Year MAC(C)E* Rates in CABG Arm *definitions vary across studies Multivessel Left Main Multivessel and/or Left Main Patients (%) SYNTAX Trial (n=897) Yang2008(n=390) ARTS I(n=602) Lee2007(n=103) Javaid 2008(n=505) Sanmartin 2007(n=245) Lee 2006(n=123)

  35. Average Stent Number and Length in ARRIVE Registry(N=7,492 patients) Multivessel disease: 36.9% 3-vessel stenting: 1.2% Avg. stents per patient: 1.6 ± 0.9 Avg. stented length: 18.6 mm Patients (%) Total Number of Stents Implanted per Patient

  36. Average Stent Number and Length in OLYMPIA Registry(N=22,345 patients) Multivessel disease: 56.5% 3-vessel stenting: 1.3% Avg. stents per patient: 1.5 ± 0.8 Avg. stented length: 29.9 mm Patients (%) Total Number of Stents Implanted per Patient

  37. Stent Number and Length Higher in the SYNTAX Trial 48% of patients received ≥5 stents Max # 14 stents! Multivessel disease: 96.2%* 3-vessel disease: 90.8% Avg. stents per patient: 4.6 ± 2.3 Avg. stented length: 86.1 mm Patients (%) Total Number of Stents Implanted per Patient *3VD+LM/3VD+LM/2VD+LM/1VD

  38. Average Number of Stents Implanted per Patient SYNTAX Trial Average number of stents implanted in SYNTAX is higher than any other contemporary DES versus CABG study 4.6±2.3 SYNTAX

  39. Average Total Stented Length SYNTAX Trial 86.1±47.9 Average total stent length (mm) SYNTAX

  40. 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

  41. 1-Year Mortality and Revascularisation Ratesin TAXUS Stent Studies Mortality Revascularisation Any Repeat Revascularization Patients (%) Target vessel only TAXUS SR Meta ARRIVESimpleUse ARRIVEMVStenting SYNTAX Trial TAXUS SR Meta ARRIVESimpleUse ARRIVEMVStenting SYNTAX Trial

  42. Contemporary studies of DES versus CABG1-Year Revascularisation in DES Arm Multivessel Left Main Multivessel and/or Left Main All Revasc. Patients (%) 35%LM All Revascularization 42%3VD 54%3VD 25%3VD 91%3VD (TVR) (All) (TLR) (TVR) (TVR) SYNTAX Trial (n=903) Yang2008(n=441) ARTS II(n=607) Hannan2008(n=9963) DELFT 2008(n=358) Sanmartin 2007(n=96) Palmerini 2006(n=157) Lee 2006(n=50) Chieffo 2006(n=107)

  43. Contemporary studies of DES versus CABG1-Year Mortality in DES Arm Multivessel Left Main Multivessel and/or Left Main Patients (%) (cardiac) Javaid 2008(n=95) DELFT 2008(n=358) SYNTAX Trial (n=903) Yang2008(n=441) ARTS II(n=607) Lee, 2007(n=102) Hannan 2008(n=9963) Sanmartin 2007(n=96) Palmerini 2006(n=157) Lee 2006(n=50) Chieffo 2006(n=107)

  44. Contemporary studies of DES versus CABG1-Year Stroke Rates in DES Arm Multivessel Left Main Patients (%) Multivessel and/or Left Main Yang2008(n=441) ARTS II(n=607) Lee 2007(n=102) Javaid 2008(n=95) Sanmartin 2007(n=96) Chieffo 2006(n=107) SYNTAX Trial (n=903)

  45. Contemporary studies of DES versus CABG1-Year MAC(C)E* Rates in DES Arm *definitions vary across studies Multivessel Left Main Patients (%) 3VD LM Yang2008(n=441) ARTS II(n=607) Lee2007(n=102) Javaid 2008(n=95) DELFT 2008(n=358) Sanmartin 2007(n=96) Lee 2006(n=50) SYNTAX Trial

  46. Atherosclerosis: A progressive process PHASE I: Initiation PHASE II: Progression PHASE III: Complication Disease progression

  47. Atherosclerotic progression:Glagov’s remodeling hypothesis Expansion overcome: lumen narrows Compensatory expansion maintains constant lumen Minimal CAD Moderate CAD Advanced CAD Progression Normal vessel Glagov S, et al. N Engl J Med. 1987;316:1371-1375.

  48. What types of lesions cause MI? Coronary stenosis severity prior to MI 100 100 14% 80 80 18% 60 60 68% Coronary stenosis (%) 40 40 20 20 0 0 Ambrose1988 Little1988 Nobuyoshi1991 Giroud1992 All 4studies <50% 50%-70% >70% Falk E, et al. Circulation. 1995;92:657-671.

  49. Atherosclerosis: The first sign of CHD is often sudden death or MI Men 62% (552/895 men) Women 45% (305/674 women) 0 10 20 30 40 50 60 70 Patients who experienced an MI (%) Murabito JM, et al. Circulation. 1993;88:2548-2555.

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