1. The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX StudyThe 3-year Outcomes of the SYNTAX Trial in the Subset of Patients With Left Main Disease Patrick W. Serruys, MD PhD Erasmus Medical Center On behalf of the SYNTAX investigators 6:00-6:10PM, Sept 21, 2010 Featured Clinical Research I Conflicts of Interest: None

2. Disclosure Statement of Financial Interest I, Patrick W. Serruys, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. SYNTAX Study Objectives The SYNTAX randomized trial is an attempt to provide an evidence base to determine the most appropriate treatment option for patients in a ‘real-world’ population seen by the surgeon and the interventional cardiologist in their daily practice In 2009, the ACC-AHA PCI Guidelines were updated and raised LM stenting from Class III to Class IIb (level B)1 In 2010, ESC-EACTS Guidelines revised and upgraded LM (isolated or in conjuction with 1 vessel disease) stenting from Class IIb （level C) to IIa (level B)2 1Kushner et al. Circulation 2009; 120:2271-2306 2Wijns et al. EHJ 2010

4. Amenable for both treatment options Amenable for only one treatment approach Randomized Arms N=1800 Two Registry ArmsN=1275 SYNTAX Trial Design + 23 US Sites 62 EU Sites Heart Team (surgeon & interventional cardiologist) Stratification: LM and Diabetes PCI n=198 CABG n=1077 TAXUS* n=903 CABG n=897 vs LM n=348(33.7%) 3VDn=549 (66.3%) 3VD n=546 (65.4%) LMn=357(34.6%) *TAXUS Express

5. Patients in SYNTAXLeft Main (LM) Subset RCT: Enrolled N=705 CABG n=348 PCI n=357 RCT: 1 Year Follow-up N=691 (98.0%) CABG n=336 PCI n=355 RCT: 2 Year Follow-up N=683 (96.9%) CABG n=331 PCI n=352 RCT: 3 Year Follow-up N=674 (95.6%) CABG n=325 PCI n=349

6. Heterogeneity in the Left Main Group Left Main Isolated n=91 (13%) Left Main + 1VD Left Main + 3VD n=258 (37%) n=138 (20%) n=218 (31%) Left Main + 2VD Site-reported data

7. Patient CharacteristicsLM Subset Core laboratory reported unless *Site-reported

8. TAXUS(N=357) CABG(N=348) 40 20 0 12 36 24 All-Cause Death to 3 YearsLM Subset P=0.64 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 Cumulative Event Rate (%) 8.4% 7.3% 0 Months Since Allocation ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates

9. TAXUS(N=357) CABG(N=348) 40 20 0 12 36 24 CVA to 3 YearsLM Subset P=0.02 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 Cumulative Event Rate (%) 4.0% 1.2% 0 Months Since Allocation ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates

10. TAXUS(N=357) CABG(N=348) 40 20 0 12 36 24 Myocardial Infarction to 3 YearsLM Subset P=0.14 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 Cumulative Event Rate (%) 6.9% 4.1% 0 Months Since Allocation ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates

11. TAXUS(N=357) CABG(N=348) 40 20 0 12 36 24 All-Cause Death/CVA/MI to 3 YearsLM Subset P=0.60 Before 1 year* 9.2% vs 7.0% P=0.29 1-2 years* 2.8% vs 3.2% P=0.76 2-3 years* 2.6% vs 3.0% P=0.76 Cumulative Event Rate (%) 14.3% 13.0% 0 Months Since Allocation ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates

12. TAXUS(N=357) CABG(N=348) 40 20 0 12 36 24 Repeat Revascularization to 3 YearsLM Subset P=0.004 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 20.0% Cumulative Event Rate (%) 11.7% Repeat CABG: 1.7% vs 5.6%, P=0.01 Repeat PCI: 10.0% vs 16.2%, P=0.01 0 Months Since Allocation ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates

13. TAXUS(N=357) CABG(N=348) 40 20 0 12 36 24 MACCE to 3 YearsLM Subset P=0.20 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 26.8% Cumulative Event Rate (%) 22.3% 0 Months Since Allocation ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates

14. CABG(n=348) TAXUS(n=357) Symptomatic Graft Occlusion & Stent Thrombosis to 3 Years LM Subset P=0.80 Patients (%) n=12 n=14 CABG TAXUS Post-procedure; ITT population

15. MACCE to 3 Years in LM Subgroups TAXUS CABG P=0.20 P=0.52 P=0.33 P=0.09 P=0.20 Patients, % n= 348 357 49 42 122 136 106 112 71 67 All LM LM + 1VD LM Isolated LM + 2VD LM + 3VD Cumulative KM Event Rate; log-rank P value; *Binary rates

16. Distal 7% 4% 11% 35% 27% Nondistal 29% 61% 66% 59% Both Vessel Distribution in LM Population According to Syntax Score Terciles 33+ 0-22 23-32

17. CTO 29.6% Non-CTO Vessel Distribution in LM Population According to Syntax Score Terciles 5.9% 16.5% 33+ 0-22 23-32

18. CABG(N=104) TAXUS(N=118) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22) Left Main > > P=0.33 23.0% < Cumulative Event Rate (%) 18.0% > < Months Since Allocation Site-reported Data; ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value

19. CABG(N=92) TAXUS(N=103) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation MACCE to 3 Years by SYNTAX Score Tercile Intermediate Scores (23-32) Left Main > > P=0.90 23.4% < 23.4% > < Site-reported Data; ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value

20. CABG(N=149) TAXUS(N=135) 40 30 Cumulative Event Rate (%) 20 10 0 0 12 24 36 Months Since Allocation MACCE to 3 Years by SYNTAX Score Tercile Left Main SYNTAX Score 33 Left Main Left Main < P=0.003 37.3% > < 21.2% < < Site-reported Data; ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value

21. SummaryLeft Main Subset At 3 years, overall MACCE in the PCI group was comparable with CABG (22.3% CABG vs 26.8% PCI) Similar overall safety outcomes (Death/CVA/MI) between CABG and PCI at 3 years (14.3% CABG vs 13.0% PCI) There was a higher rate of revascularization in the PCI group (11.7% CABG vs 20.0% PCI), and a higher rate of CVA in the CABG group (4.0% CABG vs 1.2% PCI) PCI outcomes are excellent relative to CABG in LM isolated and LM+1VD

22. Conclusions For patients with left main disease Revascularization with PCI has comparable safety and efficacy outcomes to CABG PCI is therefore a reasonable treatment alternative in this patient population, in particular, when the SYNTAX Score is low (≤22) or intermediate (23-32)