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Optimal revascularization strategy in patients with three-vessel disease and/or left main disease The 2-year Outcomes of the SYNTAX Trial A. Pieter Kappetein, MD PhD Erasmus MC, Rotterdam, NL On behalf of the SYNTAX investigators Clinical Trial Update III 2 September 2009, Room Barcelona Zone 2 9:24 AM to 9:37 AM Conflicts of Interest: None

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 2 SYNTAX Study Objectives With technological advances and changes in clinical practice, the respective values of coronary artery bypass surgery and percutaneous coronary intervention needed to be reassessed The SYNTAX randomized trial is an attempt to provide an evidence base to determine the best treatment option for patients in a real-world population seen by the surgeon and the interventional cardiologist in their daily practice

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 3 SYNTAX Trial Design De novo 3VD and/or LM (isolated, +1,2,3 VD) Limited Exclusion Criteria Previous interventions, Acute MI with CPK>2x, Concomitant cardiac surgery Previous interventions, Acute MI with CPK>2x, Concomitant cardiac surgery Two Registry Arms N=1275 Randomized Arms N=1800 Heart Team (Surgeon & Interventional Cardiologist Amenable for only one treatment approach Amenable for both treatment options Stratification: LM and Diabetes 23 US Sites 62 EU Sites +

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 4 Patient Profiling Local Heart team (surgeon & interventional cardiologist) assessed each patient with regards to: Patients 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 Sianos et al, EuroIntervention 2005;1:219-27 Valgimigli et al, Am J Cardiol 2007;99:1072-81 Serruys et al, EuroIntervention 2007;3:450-9 Coronary tree segments AHA classification and modified for the ARTS study, Circulation 1975; 51:5-40 & Semin Interv Cardiol 1999; 4:209-19 Modified Leaman score, Circ 1981;63:285-92 Lesions classification ACC/AHA, Circ 2001;103:3019-41 Bifurcation classification, CCI 2000;49:274-83 CTO classification, J Am Coll Cardiol 1997;30:649-56 www.syntaxscore.com www.syntaxscore.com available now

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 5 Patients in SYNTAX Randomized Controlled Trial Intent-to-Treat * TAXUS Express RCT: Enrolled N=1800 RCT: 1 Year Follow-up N=1740 (96.7%) PCI * n=903 CABG n=897 PCI * n=891 CABG n=849 PCI * n=885 vs vs vs RCT: 2 Year Follow-up N=1721 (95.6%) CABG n=836

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 6 Patient Characteristics Randomized Cohort CABG N=897 TAXUS N=903 P value Age *, mean ± SD (y)65.0 ± 9.8 65.2 ± 9.7 0.55 Medically treated diabetes *, %24.625.60.64 Additive euroSCORE *, mean ± SD3.8 ± 2.7 3.8 ± 2.6 0.78 Total Parsonnet score *, mean ± SD8.4 ± 6.8 8.5 ± 7.0 0.76 Total SYNTAX Score, mean ± SD29.1 ±11.4 28.4 ±11.5 0.19 No. lesions, mean ± SD4.4 ±1.8 4.3 ±1.8 0.44 3VD only, %66.365.40.70 Left main, any, %33.734.60.70 Left Main only3.13.80.46 Left Main + 1 vessel5.15.40.78 Left Main + 2 vessel12.011.50.72 Left Main + 3 vessel13.513.90.78 Core laboratory reported unless * Site-reported

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 7 Death/CVA/MI rates were similar between CABG and PCI Death/CVA/MI rates were similar between CABG and PCI Stroke was increased in CABG vs PCI Stroke was increased in CABG vs PCI Repeat revascularization and MACCE were increased in PCI vs CABG Repeat revascularization and MACCE were increased in PCI vs CABG Non-inferiority was not met for 12-month MACCE Summary of 1-Year Results P=0.98 * 0612 10 20 0 Months Since Allocation Cumulative Event Rate (%) ITT population 7.6% 7.5% KM Event Rate ± 1.5 SE. * Fishers Exact Test Death/CVA/MI 0.6% 2.2% 0612 10 20 0 Months Since Allocation Cumulative Event Rate (%) ITT population P=0.003 * KM Event Rate ± 1.5 SE. * Fisher exact test Stroke P=0.002 * 0612 10 20 0 Months Since Allocation Cumulative Event Rate (%) ITT population 12.1% 17.8% KM Event Rate ± 1.5 SE. * Fisher exact test MACCE PCI (N=903) CABG (N=897) Repeat Revasc. 5.9% 13.7% 0612 10 20 0 Months Since Allocation Cumulative Event Rate (%) ITT population P<0.001 * KM Event Rate ± 1.5 SE. * Fishers Exact Test Repeat Revasc CABG Group PCI Group PCI4.8%11.6% CABG1.3%2.9%

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 8 ITT population P=0.24 6.2% 4.9% 01224 0 Months Since Allocation Cumulative Event Rate (%) TAXUS (N=903) CABG (N=897) All-Cause Death to 2 Years 20 40 0 Cumulative KM Event Rate ± 1.5 SE; log-rank P value; * Binary rates Before 1 year * 3.5% vs 4.4% P=0.37 After 1 year * 1.5% vs 1.9% P=0.53

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 9 CVA to 2 Years 1.4% 2.8% 01224 Months Since Allocation Cumulative Event Rate (%) ITT population P=0.03 TAXUS (N=903) CABG (N=897) Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 20 40 Before 1 year * 2.2% vs 0.6% P=0.003 After 1 year * 0.6% vs 0.7% P=0.82

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 10 Myocardial Infarction to 2 Years 3.3% 5.9% 01224 Months Since Allocation Cumulative Event Rate (%) ITT population P=0.01 TAXUS (N=903) CABG (N=897) Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 20 40 Before 1 year * 3.3% vs 4.8% P=0.11 After 1 year * 0.1% vs 1.2% P=0.008

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 11 All-Cause Death/CVA/MI to 2 Years P=0.44 01224 Months Since Allocation Cumulative Event Rate (%) ITT population 9.6% 10.8% TAXUS (N=903) CABG (N=897) Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 20 40 Before 1 year * 7.7% vs 7.6% P=0.98 After 1 year * 2.2% vs 3.5% P=0.11

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 12 Repeat Revascularization to 2 Years 8.6% 17.4% 01224 Months Since Allocation Cumulative Event Rate (%) ITT population P<0.001 TAXUS (N=903) CABG (N=897) Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 20 40 Before 1 year * 5.9% vs 13.5% P<0.001 After 1 year * 3.7% vs 5.6% P=0.06

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 13 MACCE to 2 Years P<0.001 01224 Months Since Allocation Cumulative Event Rate (%) ITT population 16.3% 23.4% TAXUS (N=903) CABG (N=897) Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates 20 40 Before 1 year * 12.4% vs 17.8% P=0.002 After 1 year * 5.7% vs 8.3% P=0.03

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 14 01224 Months Since Allocation Cumulative Event Rate (%) TAXUS (N=299) CABG (N=275) P=0.63 19.4% 17.4% Calculated by core laboratory; ITT population MACCE to 2 Years by SYNTAX Score Tercile Low Scores (0-22) Mean baseline SYNTAX Score CABG16.6 ± 4.0 TAXUS16.7 ± 4.1 Cumulative KM Event Rate ± 1.5 SE; log-rank P value 20 40

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 15 01224 Months Since Allocation Cumulative Event Rate (%) Calculated by core laboratory; ITT population MACCE to 2 Years by SYNTAX Score Tercile Intermediate Scores (23-32) TAXUS (N=310) CABG (N=300) P=0.06 22.8% 16.4% Mean baseline SYNTAX Score CABG27.4 ± 2.8 TAXUS27.3 ± 2.8 Cumulative KM Event Rate ± 1.5 SE; log-rank P value 20 40

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 16 01224 Months Since Allocation Cumulative Event Rate (%) Calculated by core laboratory; ITT population MACCE to 2 Years by SYNTAX Score Tercile High Scores ( 33) TAXUS (N=290) CABG (N=315) P<0.001 28.2% 15.4% Mean baseline SYNTAX Score CABG41.5 ± 7.1 TAXUS41.7 ± 7.8 Cumulative KM Event Rate ± 1.5 SE; log-rank P value 20 40

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 17 TAXUS CABG Patients, % ITT population Death/CVA/MIMACCERevasc Time-to Event; Log-rank P value P=0.11P<0.001 Death/CVA/MIMACCERevasc P=0.48P=0.01P=0.27 2 Year Outcomes in 3VD and LM Subgroups 3 Vessel Disease n=1095 Left Main Disease n=705

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 18 Summary: I In the SYNTAX randomized patients, 2-year MACCE rates were significantly higher for PCI than CABG, mainly driven by higher repeat revascularization in the PCI arm. Significant increase of MI compared to CABG at 2 years driven by higher PCI MI rate between years 1and 2 Significantly higher CVA rate in CABG compared to PCI with the majority of CVAs occurring in the first year Composite safety (death/CVA/MI) remains similar between arms at 2 years MACCE rates at 2 years not significantly different for patients with a low (0-22) or intermediate (23-32) baseline SYNTAX Score; for patients with high SYNTAX Scores (33), MACCE continued to be increased at 2 years in patients treated with PCI

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ESC 2009 Two-year Outcomes of the SYNTAX Trial Kappetein Slide 19 In the predefined subgroups of patients with either 3VD or LM disease: Safety outcomes (death/CVA/MI) in the 3VD group were similar for PCI and CABG, but the 2-year revascularization and MACCE rates favored CABG. In the LM group, safety outcomes and MACCE rates were similar for PCI and CABG, but the 2-year revascularization rate was lower in the CABG group. The 2-year SYNTAX results suggest that CABG remains the standard of care for patients with complex disease (high SYNTAX Scores); however, PCI may be an acceptable alternative revascularization method to CABG when treating patients with less complex (low or intermediate SYNTAX Score) disease. SYNTAX patients will continue to be followed for 5 years. Summary: II

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