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The document summarizes the 3-year outcomes of the SYNTAX clinical trial for patients with left main coronary artery disease. The SYNTAX trial randomized patients with complex coronary artery disease to either coronary artery bypass grafting (CABG) or percutaneous coronary intervention with paclitaxel-eluting stents (PCI). For the 705 patients in the left main subgroup, the rates of all-cause death at 3 years were similar between CABG (8.4%) and PCI (7.3%). However, the rate of stroke was significantly higher in the CABG group (4.0%) compared to the PCI group (1.2%).
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Introduction to SYNTAX trial, aimed at understanding left main disease treatment options, highlighting updates in guidelines.
Trial included 62 EU and 23 US sites, with 1800 randomized patients in CABG and TAXUS arms (N=1275 in registry).
Left main subset involved 705 enrolled patients, with detailed demographics and follow-up rates at 1, 2, and 3 years.
Cumulative event rates for death over 3 years; rates relatively similar between CABG and TAXUS.
CVA event rates showed significant differences before 1 year, but minimal differences thereafter.
MI rates, slight differences observed across years with no significant outcome variations.
Cumulative event rates showed no significant differences in composite outcomes between treatments.
Differing rates of repeat procedures favoring PCI over CABG, significant findings in event rates.
Cumulative event rates for MACCE showed no significant differences between CABG and TAXUS.
Symptomatic occlusion and stent thrombosis rates were not significantly different between groups.
Rates in the left main subgroups showing variations across isolated and multi-vessel diseases.
Distribution patterns based on Syntax scores, highlighting non-distal and distal lesions.
Assessment of outcomes based on low Syntax scores showing variations in event rates.
Reported outcomes similar to low scores, showing comparable results for CABG and TAXUS.
High Syntax scores indicating differential outcomes, with significant rates of revascularization.
Overall MACCE rates comparable; higher revascularization and CVA rates observed, suggesting PCI efficacy.
Conclusions supporting PCI as a comparable alternative to CABG for patients with left main disease.
Reference to 2010 ESC-EACTS guidelines on myocardial revascularization.
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- 1. The Synergy betweenPercutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study The 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 TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 1
- 2. Disclosure Statement ofFinancial 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 TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 3
- 4. SYNTAX Trial Design 62 EU Sites + 23 US Sites Heart Team (surgeon & interventional cardiologist) Amenable for both Amenable for only one treatment options treatment approach Stratification: LM and Diabetes Randomized Arms Two Registry Arms N=1800 N=1275 CABG TAXUS* CABG PCI n=897 vs n=903 n=1077 n=198 3VD LM 3VD LM n=549 n=348 n=546 n=357 (66.3%) (33.7%) (65.4%) (34.6%) * TAXUS Express TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 4
- 5. Patients in SYNTAX Left Main (LM) Subset CABG RCT: Enrolled PCI n=348 N=705 n=357 CABG RCT: 1 Year Follow-up PCI n=336 N=691 (98.0%) n=355 CABG RCT: 2 Year Follow-up PCI n=331 N=683 (96.9%) n=352 CABG RCT: 3 Year Follow-up PCI n=325 N=674 (95.6%) n=349 TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 5
- 6. Heterogeneity in theLeft Main Group Left Main Isolated n=91 (13%) Left Main + 3VD n=258 Left Main + 1VD (37%) n=138 (20%) n=218 (31%) Left Main + 2VD Site-reported data TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 6
- 7. Patient Characteristics LM Subset CABG TAXUS N=348 N=357 P value Age*, mean ± SD (y) 65.6 ± 10.1 65.4 ± 9.8 0.78 Medically treated diabetes*, % 22.4 21.8 0.86 BMI, mean ± SD 27.7 ± 5.0 28.2 ± 4.9 0.24 Additive euroSCORE*, mean ± SD 3.9 ± 2.9 3.9 ± 2.8 0.91 Total Parsonnet score*, mean ± SD 9.1 ± 7.4 8.9 ± 7.8 0.77 Total SYNTAX Score, mean ± SD 26.7 ± 11.5 28.1 ± 12.4 0.13 No. lesions, mean ± SD 3.2 ± 1.9 3.3 ± 1.8 0.89 Core laboratory reported unless *Site-reported TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 7
- 8. All-Cause Death to3 Years LM Subset CABG (N=348) TAXUS (N=357) P=0.64 Cumulative Event Rate (%) 40 Before 1 year* 1-2 years* 2-3 years* 4.5% vs 4.2% 1.9% vs 1.5% 2.3% vs 1.8% P=0.88 P=0.68 P=0.67 20 8.4% 7.3% 0 0 12 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 8
- 9. CVA to 3Years LM Subset CABG (N=348) TAXUS (N=357) P=0.02 Cumulative Event Rate (%) 40 Before 1 year* 1-2 years* 2-3 years* 2.7% vs 0.3% 0.9% vs 0.6% 0.3% vs 0.3% P=0.009 P=0.68 P=1.00 20 4.0% 1.2% 0 0 12 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 9
- 10. Myocardial Infarction to3 Years LM Subset CABG (N=348) TAXUS (N=357) P=0.14 Cumulative Event Rate (%) 40 Before 1 year* 1-2 years* 2-3 years* 4.2% vs 4.2% 0.0% vs 1.2% 0.0% vs 1.5% P=0.97 P=0.12 P=0.06 20 6.9% 0 4.1% 0 12 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 10
- 11. All-Cause Death/CVA/MI to3 Years LM Subset CABG (N=348) TAXUS (N=357) P=0.60 Cumulative Event Rate (%) 40 Before 1 year* 1-2 years* 2-3 years* 9.2% vs 7.0% 2.8% vs 3.2% 2.6% vs 3.0% P=0.29 P=0.76 P=0.76 20 14.3% 13.0% 0 0 12 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 11
- 12. Repeat Revascularization to3 Years LM Subset CABG (N=348) TAXUS (N=357) P=0.004 Cumulative Event Rate (%) 40 Before 1 year* 1-2 years* 2-3 years* 6.5% vs 11.8% 5.0% vs 8.2% 2.6% vs 3.9% P=0.02 P=0.10 P=0.36 20.0% 20 Repeat CABG: 1.7% vs 5.6%, P=0.01 11.7% Repeat PCI: 10.0% vs 16.2%, P=0.01 0 0 12 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 12
- 13. MACCE to 3Years LM Subset CABG (N=348) TAXUS (N=357) P=0.20 Cumulative Event Rate (%) 40 Before 1 year* 1-2 years* 2-3 years* 13.7% vs 15.8% 7.5% vs 10.3% 5.2% vs 5.7% 26.8% P=0.44 P=0.22 P=0.78 20 22.3% 0 0 12 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 13
- 14. Symptomatic Graft Occlusion& Stent Thrombosis to 3 Years LM Subset CABG (n=348) TAXUS (n=357) Patients (%) P=0.80 3.7 4.1 n=12 n=14 CABG TAXUS Post-procedure; ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 14
- 15. MACCE to 3Years in LM Subgroups CABG TAXUS 40 P=0.20 P=0.52 P=0.33 P=0.09 P=0.20 31.7 31.1 30 26.8 26.7 Patients, % 22.3 22.8 21.2 19.4 20 17.0 11.9 10 0 n= 348 357 49 42 71 67 106 112 122 136 All LM LM LM LM LM Isolated + 1VD + 2VD + 3VD Cumulative KM Event Rate; log-rank P value; *Binary rates TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 15
- 16. Vessel Distribution inLM Population According to Syntax Score Terciles 4% 11% 7% Nondistal 35% 29% 27% Distal 61% 59% 66% Both 0-22 23-32 33+ TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 16
- 17. Vessel Distribution inLM Population According to Syntax Score Terciles 5.9% 16.5% 29.6% Non-CTO CTO 0-22 23-32 33+ TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 17
- 18. MACCE to 3Years by SYNTAX Score Tercile Low Scores (0-22) CABG (N=104) CABG PCI P value TAXUS (N=118) Left Main Death 6.0% > 2.6% 0.21 40 Cumulative Event Rate (%) CVA 4.1% > 0.9% 0.12 30 P=0.33 23.0% 20 MI 2.0% < 4.3% 0.36 18.0% Death, 10 CVA or 11.0% > 6.9% 0.26 MI 0 0 12 24 36 Revasc. 13.4% < 15.4% 0.69 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 18
- 19. MACCE to 3Years by SYNTAX Score Tercile Intermediate Scores (23-32) CABG (N=92) CABG PCI P value TAXUS (N=103) Left Main Death 12.4% > 4.9% 0.06 40 Cumulative Event Rate (%) CVA 2.3% > 1.0% 0.46 30 P=0.90 23.4% 23.4% 20 MI 3.3% < 5.0% 0.63 Death, 10 CVA or 15.6% > 10.8% 0.29 MI 0 0 12 24 36 Revasc. 14.0% < 15.9% 0.75 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 19
- 20. MACCE to 3Years by SYNTAX Score Tercile Left Main SYNTAX Score 33 CABG (N=149) CABG PCI P value TAXUS (N=135) Left Main Death 7.6% < 13.4% 0.10 40 P=0.003 37.3% Cumulative Event Rate (%) CVA 4.9% > 1.6% 0.13 30 20 21.2% MI 6.1% < 10.9% 0.18 Death, 10 CVA or 15.7% < 20.1% 0.34 MI 0 0 12 24 36 Revasc. 9.2% < 27.7% <0.001 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 20
- 21. Summary Left 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 TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 21
- 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) TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 22
- 23. Joint 2010 ESC- EACTS Guidelines www.escardio.org/guidelines on Myocardial Revascularisation
Editor's Notes
- #5 SYNTAX_CSR_Randomized_Unblinded_2008Oct10.docex. 1 title; intent to treat.exhibit 52, 53 % calculated by handRegistry: SYNTAX_CSR_Registry_Unblinded_2008Oct10.doc exhibit 2, 21 QC Comments:Note: Per Kristine, this slide has been QC’ed before. No QC needed.Please check the percents in last 4 boxes at bottom left.
- #12 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 522-Year_Randomized_20090820.doc Exhibits 21SYNTAX 3-Year Report_Randomized_12JUL10.doc exhibits 21 (KM overall rate), 22 (year 2-3)
- #14 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 522-Year_Randomized_20090820.doc Exhibits 21SYNTAX 3-Year Report_Randomized_12JUL10.doc exhibits 21 (KM overall rate), 22 (year 2-3)
- #22 SYNTAX 3-Year Report_Randomized_12JUL10.docex.1
- #24 8 anatomic patterns of disease (1 or 2 vd with/without proximal LAD, 3vd being ‘simple or complex,4 categories of left main)CABG is stilll considered IA for all except ½ vd not involving prox LAD (comparable to Appropriateness recommendations by six US organizations)½ vd +prox LAD CABG is IA because of proven durability of IMA graft over decades of follow upFor 3vd PCI had different recommendations depending on complexityFor LM easing of previous ESC recommendations and more than appropriateness recommendations and may change again with further trials