Michael Mack, M.D. Baylor Healthcare System Heart Hospital Baylor Plano Dallas, TX
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1 Michael Mack, M.D. Baylor Healthcare System Heart Hospital Baylor Plano Dallas, TX
2 Boston Scientific, Inc.- Syntax Trial Steering Committee Member- travel expenses paid by trial sponsor Maquet, Inc.- unpaid consultant Cordis, Inc.- unpaid consultant
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8 Raj, my son, All compromise is based on give and take, but there can be no give and take on fundamentals
9 Contemporary Trials of LM CABG vs PCI Superior Treatment Modality for Outcomes Trial * N Death MI Stroke Revasc Sanmartin MAIN-COMPARE LEMANS Palmerini ND Chieffo PCI better PCI Lee ND better ND Brener Makikallio White ND n/a CABG better n/a n/a n/a * Studies with >100 patients per arm reported ND=no difference; n/a=not available/not reported SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 9
10 * Guidelines: Stable Angina 02, UA/NSTEMI 02, CABG 04, PCI 05 I IIa IIb III CABG is recommended for patients with stable, unstable and NSTEMI who have significant left main disease Use of PCI in patients with significant left main CAD who are candidates for CABG PCI for LM in surgical candidates is currently considered experimental in US
11 I IIa IIb III CABG is recommended for patients with stable, unstable and NSTEMI who have significant left main disease Use of PCI in patients with significant left main CAD who are candidates for CABG * Guidelines: Stable Angina 02, UA/NSTEMI 02, CABG 04, PCI 05
12 Panel of 17 Experts 4 Interventional Cardiologists 4 Cardiac Surgeons
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19 DISTRACTION
20 Left Main PCI vs. CABG Randomized Trials LeMans (Poland) Leipzig Syntax
21 JACC 2008 SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 21
22 SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 22
23 SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 23
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28 SYNTAX Trial Design 62 EU Sites + 23 US Sites Randomized Arms N=1800 CABG n=897 3VD 66.3% Heart Team (surgeon & interventionalist) Amenable for both treatment options LM 33.7% vs TAXUS * n=903 3VD 65.4% Stratification: LM and Diabetes LM 34.6% Two Registry Arms N=1275 CABG n=1077 5yr f/u n=649 Amenable for only one treatment approach no f/u n=428 PCI n=198 * TAXUS Express SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 28
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30 Cumulative Event Rate (%) MACCE to 2 Years CABG (N=897) TAXUS (N=903) P< Before 1 year * 12.4% vs 17.8% P=0.002 After 1 year * 5.7% vs 8.3% P= % 16.3% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*binary rates ITT population SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 30
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32 SO, IS THAT THE END OF THE DEBATE? SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 32
33 Why This Is Not The Final Answer Results are only 2 years and 3 and 5 year followup will be available Major difference in MACCE is Repeat Revascularization
34 SINCE THE PRE-DEFINED ENDPOINT WAS NOT ACHIEVED, POST-HOC STRATIFICATION IS NOT PERMISSIBLE Therefore, further comparisons for the LM and 3VD subgroups are observational only and hypothesis generating
35 There is Left Main Disease and Left Main Disease
36 Caveat-Subgroup Analysis Number of subgroup analysis = subgroups X outcomes SUBGROUPS All LM LM only LM+1VD LM+2VD LM+3VD Low Syntax Intermediate Syntax High Syntax All 3VD Low Syntax Intermediate Syntax High Syntax Diabetics OUTCOMES MACCE Death Stroke MI Death/Stroke/MI Repeat Revascularization 13 subgroups X 6 outcomes = 78 subgroup analyses
37 MACCE to 2 Years by SYNTAX Score Tercile Low Scores (0-22) LM Subset Cumulative Event Rate (%) CABG (N=104) TAXUS (N=118) 40 Mean baseline SYNTAX Score CABG TAXUS P= % 15.5% Months Since Allocation Event rate ± 1.5 SE, log-rank P value Calculated by core laboratory; ITT population
38 MACCE to 2 Years by SYNTAX Score Tercile Intermediate Scores (23-32) LM Subset Cumulative Event Rate (%) CABG (N=92) TAXUS (N=103) 40 Mean baseline SYNTAX Score CABG TAXUS P= % 22.4% Months Since Allocation Event rate ± 1.5 SE, log-rank P value Calculated by core laboratory; ITT population
39 MACCE to 2 Years by SYNTAX Score Tercile High Scores ( 33) Left Main Subset Cumulative Event Rate (%) CABG (N=149) TAXUS (N=135) 40 Mean baseline SYNTAX Score CABG TAXUS P= % % Months Since Allocation Event rate ± 1.5 SE, log-rank P value Calculated by core laboratory; ITT population
40 Possible Candidates For PCI in Syntax- Left Main /1,282 (23-41%) PCI Registry Low Tertile CABG Registry Intermediate Tertile High Tertile Circulation 2010; In Press
41 SINCE THE PRE-DEFINED ENDPOINT WAS NOT ACHIEVED, POST-HOC STRATIFICATION IS NOT PERMISSIBLE. Therefore, further comparisons for the LM and 3VD subgroups are observational only and hypothesis generating
42 THE NEW HYPOTHESIS GENERATED!
43 EXCEL Evaluation of Xience Prime versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization
44 EXCEL: Study Design Draft design 4000 pts with left main disease SYNTAX score 32 Consensus agreement by heart team No (N=1500) PCI (Xience Prime) (N=1250) Yes R (N=2500) CABG (N=1250) PCI and CABG registries (limited in-hosp data) Clinical follow-up: 30 days, 6 months, yearly through 5 years This trial design has not yet been reviewed by the US FDA and is subject to change
45 EXCEL: Angiographic Draft design Exclusion Criteria Left main DS <50% (visually assessed) SYNTAX score 33 Left main RVD <2.25 mm or >4.5 mm This trial design has not yet been reviewed by the US FDA and is subject to change
46 EXCEL: Endpoints Draft design Primary endpoint: Death, MI, or stroke at median follow-up of 3 years Major secondary endpoint: Death, MI, stroke or unplanned revascularization at median follow-up of 3 years Power analysis: Both endpoints are powered for sequential noninferiority and superiority testing Quality of life and cost-effectiveness assessments: At regular intervals This trial design has not yet been reviewed by the US FDA and is subject to change
47 EXCEL: Status After 12 months of preparation the protocol is nearly finalized The site selection process is underway FDA meetings and global regulatory submissions are being prepared First patient enrolled: 3 rd Quarter
48 Legacy of SYNTAX Syntax Score for assessing coronary artery disease complexity Heart Team approach for assessing treatment options
49 Heart Team Approach For LM and 3VD
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53 An error does not become truth by reason of multiplied propagation
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55 SYNTAX-LE MANS Trial Design All RCT patients with LM 271 patients consented at 49 sites (13 US, 36 EU) CABG N=115 TAXUS N=156 3 pts died * 15 mo angio performed CABG N=115 TAXUS N= mo angio analyzed CABG N=114 TAXUS N=149 * 2 cardiac death: 1 cardiomyopathy and 1 sudden cardiac death
56 Grafts (%) Patients (%) Principal Results CABG Cohort Primary Endpoint (Per graft): 50% to <100% =100% Per patient: 50% to <100% =100% 20 16% 30 27% 6% (15/262) 20 9% (10/114) 10 10% (26/262) 10 18% (21/114) 0 Obstruction/occlusion Ratio at 15 mo (per graft) 0 Obstruction/occlusion Ratio at 15 mo* (per patient) Definitions: Occlusion Ratio: ratio of 50% obstructed or 100% occluded grafts/anastomoses (visual estimate) to the number of grafts/anastomoses placed *Proportion of patients with at least 1 obstructed/occluded graft
57 Grafts (%) Patients (%) Secondary Results at 15 Months CABG Cohort Per Graft: 60 51% Per Patient: 60 54% % 22% 15% Baseline Complete Revasc: 65% 0 21/41 14/41 9/41 6/41 Ostium/ Distal Body of String Proximal Graft Sign Pattern & location of stenosis (QCA) per graft * 0 61/114 Complete Revascularization of the LM and LM territory at 15 mo Definitions: Complete Revascularization: revascularisation at follow-up is defined as unimpaired flow to all distal beds (vessels showing a significant lesion have been grafted and do not show significant graft lesions at follow up, nor new significant lesions in other vessels)..string Sign: diffuse narrowing with largest diameter <1 mm *Note that the presence of ostial/proximal occlusion would mask the detection of downstream stenosis. Patients may be counted in >1 category.
58 Patients (%) MACCE at 15 Months CABG Cohort 10 9% MACCE 5% Death/ CVA/MI 0% Death (all-cause) 3% 3% 4% 10/114 6/114 3/114 3/114 5/114 CVA MI Revasc Analysis includes results from all lesions.
59 Graft Obstruction/Occlusion Not Associated With MACCE at 15 Mo CABG Cohort P= <50% Graft Stenosis 50% Graft Stenosis 91% 9% % 10% 75/82 7/ /31 3/31 No MACCE MACCE No MACCE MACCE
60 Patients (%) Patients (%) Principal Results TAXUS Cohort Primary Endpoint: % % 90% /145 <50% stenosis at 15 mo 0 47/48 87/97 LM Non-distal LM Distal <50% stenosis at 15 mo Definitions: Diameter stenosis was assessed by QCA
61 Patients (%) Patients (%) Secondary Results at 15 months TAXUS Cohort 60 53% Baseline Complete Revasc: 67% /149 2/149 0 Complete revascularization Thrombus of LM and LM territory 1% 0% 0/149 Aneurysm Definitions: Diameter stenosis was assessed by QCA
62 Millimeters Millimeters Non-distal LM Angio Endpoints (QCA) TAXUS Cohort Vessel Size: Acute Gain/Late Loss: mm mm 0 Minimum Lumen Diameter Reference Vessel Diameter 0 Acute gain (in-stent) Late loss (in-stent) Pre-procedure Post-procedure 15 Months
63 Patients (%) MACCE at 15 Months TAXUS Cohort % 9% MACCE 6% Death/ CVA/MI 2% Death (allcause) 1% 4% 20/156 10/156 3/156 2/156 6/156 14/156 CVA MI Revasc Analysis includes results from all lesions.
64 Stent Patency Significantly Associated With MACCE at 15 Months TAXUS Cohort P= <50% Diameter Stenosis 50% Diameter Stenosis 91% % 55% % 12/134 MACCE / /11 6/11 No MACCE MACCE No MACCE
65 Conclusions CABG Cohort 10% of LM placed grafts/anastomoses were 100% occluded at 15 months post-procedure and an additional 6% were 50% obstructed 54% of patients had complete revascularization * of LM & LM territory at 15 months (baseline 65%) Graft obstruction/occlusion in grafts bypassing LM lesion(s) was not significantly associated with MACCE at 15 months * Note that definitions of complete revascularization differ between treatments and should not be compared.
66 Conclusions TAXUS Cohort 92% of treated LM lesion(s) had <50% stent stenosis at 15 months post-procedure Restenosis more common with LM distal lesions than with LM non-distal lesions 53% complete revasc of LM & LM territory (baseline 67%) *, 1% thrombus, and 0% aneurysm at 15 months Minimal Late Loss in non-distal LM lesions at 15 months In-stent stenosis was significantly associated with MACCE at 15 months *Note that definitions of complete revascularization differ between treatments and should not be compared.
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70 A 'No' uttered from the deepest conviction is better than a 'Yes' merely uttered to please, or worse, to avoid trouble A man is but the product of his thoughts what he thinks, he becomes. All compromise is based on give and take, but there can be no give and take on fundamentals. Any compromise on mere fundamentals is a surrender. For it is all give and no take. nor does truth become error because nobody sees it. Commonsense is the realised sense of proportion. Honest disagreement is often a good sign of progress
71 Complexity Complexity of PCI-treated patients is increasing Left Main CTO Bifurcation Multiple Vessels Small Vessels Long Lesion Single Vessel CABG PCI Time Today SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 71
72 Syntax September 3, 72 Timing of Stroke CABG PCI Total 25 (2.8%) 12 (1.4%) Pre-procedure 3 (0.3%) 0 Procedural- 30 days 9 (1%) 2 (0.2%) 30 days- 1 Year 7 (0.8%) 3 (0.3%) 1-2 years 6 (0.6%) 7 (0.7%)
73 Syntax September 3, 73 Timing of Stroke CABG PCI Total 25 (2.8%) 12 (1.4%) Pre-procedure 3 (0.3%) 0 Procedural- 30 days 9 (1%) 2 (0.2%) 30 days- 1 Year 7 (0.8%) 3 (0.3%) 1-2 years 6 (0.6%) 7 (0.7%)
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75 Raj, my son, All compromise is based on give and take, but there can be no give and take on fundamentals
76 Cumulative Event Rate (%) CVA to 2 Years CABG (N=897) TAXUS (N=903) P= Before 1 year * 2.2% vs 0.6% P=0.003 After 1 year * 0.6% vs 0.7% P= Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*binary rates 2.8% 1.4% ITT population SYNTAX: Trial Design and Philosophy Serruys TCT 14 October 2008 Slide 76
77 Message/ Lessons for Surgeons Screen the ascending aorta on all patients Perform an off pump no touch aortic technique if disease present
Michael Mack, M.D. Baylor Healthcare System Heart Hospital Baylor Plano Dallas, TX
Michael Mack, M.D. Baylor Healthcare System Heart Hospital Baylor Plano Dallas, TX Maquet, Inc.,- unpaid consultant Cordis, Inc.,- unpaid consultant Boston Scientific, Inc.,- travel expenses paid for Syntax
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