PCI vs. CABG From BARI to Syntax, Is The Game Over?

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1 PCI vs. CABG From BARI to Syntax, Is The Game Over? Seung-Jung Park, MD, PhD Professor of Medicine, University of Ulsan College of Medicine Asan Medical Center, Seoul, Korea

2 PCI vs CABG Multi-Vessel Disease Meta-Analysis of RCTs BARI 2D FREEDOM SYNTAX

3 5 Year Survival Meta-analysis of 23 RCTS, 9,963 patients treated with PTCA or BMS vs CABG Surviving patients/all patients Study, year PCI CABG Risk difference (95% CI) BARI, / /914 EAST, / /177 GABI, / /165 RITA, / /501 French Monocentric Study, /76 68/76 Balloon overall 1,656/1,852 1,676/1,833 ARTS, / /584 AWESOME, /38 19/26 ERACI II, / /225 MASS II, / /203 BMS overall 958/1, /1,038 MVD overall 2,614/2,910 2,603/2, Ann Int Med 147:708, 2007 P=NS PCI better CABG better

4 More Strokes in CABG Surviving patients/all patients Study, year PCI CABG Risk difference (95% CI) ARTS, / /605 AWESOME, / /232 BARI, / /914 EAST, / /194 ERACI II, / /225 GABI, / /177 Drenth et al, /51 51/51 Diegeler et al, / /110 MASS, /72 70/70 MASS II, / /203 Octostent, / /142 Cisowski et al, /50 50/50 RITA, / /501 Hong et al, /119 69/70 SIMA, /63 60/60 Overall 3,640/3,660 3,561/3,604 Ann Int Med 147:708, 2007 P=0.002 PCI better CABG better

5 Treatment Effect in Subgroups Total mortality* (n/n) 5-year mortality (%) Hazard ratio (95% CI)* P value CABG PCI CABG PCI Age<55 years 107/ / % 5.0% 1.25 (0.94/1.66) Age years 201/ / % 9.4% 0.90 ( ) Age>65 yeas 267/ / % 14.7% 0.82 ( ) Women 162/ / % 12.0% 1.02 ( ) Men 413/ / % 9.4% 0.88 ( ) 0.25 No diabetes 432/ / % 8.1% 0.98 ( ) Diabetes 143/ / % 20.0% 0.70 ( ) Not smoking 393/ / % 9.5% 0.87 ( ) Smoking 158/ / % 10.9% 1.11 ( ) No hypertension 268/ / % 8.7% 0.90 ( ) Hypertension 306/ / % 11.5% 0.93 ( ) 0.73 Normal cholesterol 236/ / % 0.84 ( ) hypercholeserolaemia 221/ / % 0.93 ( ) 0.46 No PVD 374/ / % 9.1% 0.92 ( ) PVD 91/ / % 22.1% 0.78 ( ) 0.33 Hlatky MA et al. Lancet 2009;373:1190 CABG better PCI better

6 PCI (Balloon PTCA and BMS) vs. CABG In Multi-Vessel Disease 1. No Difference in Mortality and Death or MI between the two group. 2. TVR is Higher in PCI group. 3. Stoke is Higher in CABG group. 4. Better Survival, in Diabetics and Older Age (>65year) in CABG group.

7 Diabetic Concerns,

8 Survival (%) BARI 10-Year Survival PTCA vs. CABG in Multi-Vessel Disease From 1988 to Unsuspected Finding in Patients with Diabetes ND CABG 78.2% ND PTCA 76.8% DM, CABG 57.1% DM, PTCA 44.1% 20 No Diabetes CABG vs PTCA: p = 0.50 Diabetes CABG vs PTCA: p = Years Diabetes CABG (n=180) No diabetes CABG (n=734) Diabetes PTCA (n=173) No diabetes PTCA (n=742)

9 Syntax, Diabetic Subgroup No Diabetes n=1348 Diabetes * n=452 P value Age, yrs Male, % <0.001 Body Mass Index (Kg/m2) <0.001 Metabolic Syndrome % <0.001 Clinical Baseline Risk Increased Increased waist circumference <0.001 Hypertension, % <0.001 Hyperlipidemia, % Current smoker, % Congestive heart failure, % Peripheral vascular disease, % <0.001 Prior stroke, % Creatinine >200 µmol/l EuroSCORE <0.03 Parsonnet score <0.001

10 Syntax, Diabetic Subgroup No Diabetes n=1348 Diabetes * n=452 P value Lesion Complexity Diffuse disease or small vessel % Angiographic Baseline Risk Increased Average implanted stent diameter, mm <0.001 Total stent length, mm SYNTAX score Number of lesions Left main, any % vessel disease only

11 Syntax, Diabetic Subgroup (n=452), 3 Year Outcomes CABG TAXUS P=0.53 P<0.001 P=0.002 % Death/stroke/MI Revasc MACCE Banning AP et al, JACC 2010;55:

12 Diabetes, Why Problem? 1. Diabetes was associated with more metabolic risk factors and more co-morbidities status. 2. Diabetes was associated more complex coronary lesion morphology which tended to have increased repeat revascularization rates with PCI. 3. Diabetic injury responses of stented segment should be more exaggerated with accelerated atherogenesis and active inflammatory process, which may be related with higher rate of MACE. Banning AP et al, JACC 2010;55:

13 BARI 2D Bypass Angioplasty Revascularization Investigation 2 Diabetes ; Focused on the Diabetes

14 Survival Event Free Prompt Revascularization (PCI or CABG) vs. Medical Therapy (n=1,185) All-cause Mortality Death/MI/Stroke (%) % Rev 87.8% Med (%) % Rev 75.9% Med P= P=0.70 Prompt Revascularization Prompt Revascularization 20 Intensive Medical 20 Intensive Medical Years Since Randomization Years Since Randomization

15 Survival (%) Event-free Survival (%) BARI 2D: PCI vs. Medical Treatment (Lower Risk Patients) Survival Freedom from MACE (death, MI, or stroke) PCI Medical Therapy PCI Medical Therapy Years Diff [95%CI] = 0.5% [-2.0%, 3.1%] P= Years Diff [95%CI] = 1.3% [-2.2%, 4.9%] P= The BARI 2D Study Group.NEJM 2009;360:

16 Survival (%) BARI 2D: CABG vs. Medical Treatment (Higher Risk Patients) Event-free Survival (%) Survival Freedom from MACE (death, MI, or stroke) Among high 100 CABG risk patients, CABG reduces MACE CABG compared with medical therapy, mainly related Medical Therapy 83.6 with lower rate of myocardial Medical infarction. Therapy Years P= Years P= The BARI 2D Study Group.NEJM 2009;360:

17 FREEDOM Future REvascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease

18 BASELINE CHARACTERISTICS PCI CABG P value No. of Patients Age, yrs Male, % Body Mass Index (Kg/m2) Hypertension, % 85% 85% 0.75 Hyperlipidemia, % 84% 83% 0.66 Current smoker, % 15% 17% 0.31 Congestive heart failure, % 26% 28% 0.25 Prior Stoke 4% 3% 0.31 LV EF <40% 3% 2% 0.07 EuroScore Syntax Score Three vessel disease No.of lesion No.of stented lesion or graft vessel NA CTO lesion 6% 6% 0.99 Bifurcation lesion 22% 21% 0.06

19 Death/Stroke/MI, % Farkouh et al, NEJM 2012 November 4 Primary Endpoint, Death / MI / Stroke 30 PCI/DES 26.6% Log-rank P= CABG 18.7% Years PCI/DES N CABG N

20 Stroke, % All-Cause Mortality, % Death Repeat Revascularization, % Myocardial Infarction, % MI Log-rank P=0.049 PCI/DES 16.3% 20 Log-rank P< PCI/DES 13.9 % PCI/DES N CABG N 10 CABG 10.9% Years post-randomization PCI/DES N CABG N 10 0 CABG 6.0% Years post-randomization Stroke Repeat Revascularization PCI/DES N CABG N Log-rank P= Years post-randomization CABG 5.2% PCI/DES 2.4% PCI/DES N CABG N Log-rank P< PCI/DES 13% CABG Months post-procedure %

21 Clinical Outcomes at 2 and 5 Years, FREEDOM 2 year 5 year P value Number (%) PCI CABG PCI CABG Primary Composite CABG was superior to PCI with DESs In patients with diabetes and advanced > CAD (predominantly, 3 vessel). > 121 (13.0) 108 (11.9) 200 (25.5) 146 (18.7) Any Death 62 (6.7) 57 (6.3) 114 (16.3) 83 (10.9) MI 62 (6.7) 42 (4.7) 98 (13.9) 48 (6.0) <0.001 Stroke 14 (1.5) 24 (2.7) 20 (2.4) 37 (5.2) 0.03 CV Death 9 (0.9) 12 (1.3) 73 (10.9) 52 (6.8) 0.12 > <

22 SYNTAX 5 Year Outcomes

23 Patient Characteristics CABG RCT N=897 PCI RCT N=903 P value Age * (y) 65.0± ± Male, % Diabetes *, % Additive euroscore * 3.8± ± Total Parsonnet score * 8.4± ± Total SYNTAX Score 29.1± ± Mean # of lesions 4.4± ± VD only, % Left main, any, % Total occlusion, % Complete revasc, % Values are mean±sd or %. Core laboratory reported unless * Site-reported Medically treated

24 SYNTAX 3 VD, 5 Year Outcomes CABG PCI P value MACCE 24.2% 37.5% <0.001 All-cause mortality 9.2% 14.6% Cardiac mortality 4.0% 9.0% MI 3.3% 10.6% <0.001 Death/CVA/MI 14.0% 22.0% <0.001 Repeat revascularization Is CABG the Game is Better Over!!? 12.6% 25.4% <0.001 CVA 3.4% 3.04% 0.66

25 SYNTAX Trial Complete Revascularization, Small Vessel Included (<1.5 mm) Average Number of Stents

26 Message from SYNTAX, 5 Year Outcomes 1. Complete Revascularization of All vessel, 2. Small Syntax Vessel Concept (1.5 mm in of Diameter) PCI is included, 3. Only Angio-Guided (>50%), 4. Using Too Many Ugly DES (TAXUS 4.6/pt) 5. Can Make a Worst Clinical Outcomes. Outdated from Current Practice!

27 We Are Evolving Now, Smart New DES 2. Better Concept of PCI, Does More Stents Mean More Care? Is Complete Revascularization Necessary? Reasonable Incomplete Revascularization. Ischemia Guided PCI is Better, FFR Guided PCI is Better, Integrated Use of FFR and IVUS

28 Past Story, BARI 2D FREEDOM SYNTAX Old DES, DES 35%, BMS 56%, Others 9% SES 49%, PES 41%, Others 10% PES 100%,

29 Cumulative risk of restenosis Cumulative risk of Stent Thrombosis New DES is Clearly Better! SCAAR Registry (94,384 pts) Restenosis Definite ST BMS BMS Old DES Old DES New DES New DES Time after PCI (months) Time after PCI (months) Sarno et al, Eur Heart J 2012

30 Better Concept of PCI, Does More Stents Mean More Care? Is Complete Revascularization Necessary? Reasonable Incomplete Revascularization. Ischemia Guided PCI is Better, FFR Guided PCI is Better, Integrated Use of FFR and IVUS

31 1 Year Repeat Revascularization, % More Stents Means Just More MACCE! SYNTAX: RCT (n=4.6) Dejan et al. (n=3.3) Li Y et al. (n=2.7) SYNTAX:Registry (n=3.1) FAME, Angio guided, (n=2.7) PRECOMBAT (n=2.7) AUTAX (n=3.2) FAME FFR guided (n=1.9) ASAN Multivessel Registry (n=2.8) Stent Number

32 Impact of Complete Revascularization Unadjusted Outcomes of MACCE % 40 MACE MACCE 30 P=0.91 P= Incomplete Revascularization Complete Revascularization At risk IR CR Kim YH et al, Circulation. 2011;123:

33 Impact of Complete Revascularization Adjusted Outcomes of MACCE All PCI Definitions Multivariate adjustment IPTW 95% CI 95% CI HR p HR No Different LL Clinical UL OutcomesLL UL Between Complete vs. Incomplete Revascularization in DES era with Optimal Medical Treatment Angiographic CR Angiographic CR Proximal CR Angiographic CR Angiographic CR Proximal CR p Kim YH et al, Circulation. 2011;123:

34 Reasonable Incomplete Revascularization With Optimal Medical Treatment Physiology FFR > 0.80 Function Anatomy These Are Cosmetic Angioplasty! Optimal Medical Treatment is Very Enough. Non-viable myocardium Very small vessels < 5% residual ischemic area, Jailed asymptomatic Small ischemic area side branch Not culprit artery

35 Cumulative Survival (%) Ischemia* Guided PCI Has Better Clinical Outcomes MACCE at 5 Years 30 Non-IG Ischemia Guided Thallium Perfusion Scan (+)* 20 P= % 17.4 % At risk IG IG Months Kim YH et al, JACC 2012;60:

36 FFR Guided PCI is Better, Meta-Analysis FFR vs. CAG Guided PCI A total of 9,301 patients (1 randomized trial and 4 observational studies) Park SJ, Ahn JM, Unpublished Data, 2013

37 FFR vs. Angio-Guided PCI (Meta-analysis n=9,301) Death Odds Ratio Lower Limit Upper Limit Z- Value P-Value Wongpraparut Odds ratio and 95% CI Pijls Angkananard Puymirat Lerman Random pooled estimate I 2 = < Favor FFR Favor CAG

38 FFR vs. Angio-Guided PCI (Meta-analysis n=9,301) Relative Outcomes Risk Reduction Death FFR Guided 42% PCI Has Better Clinical Outcomes! MI TVR 53% 30% MACE 29% P value <0.001 < <0.001 Park SJ, Ahn JM et al. Unpublished data, 2013

39 Impact of FFR Guided PCI, from AMC Registry How Much Synergetic? Integrated Use of FFR and IVUS

40 Integrated Use of FFR and IVUS (AMC data, n=5097) Before Routine Use of FFR (N=2699) After Routine Use of FFR (N=2398) IVUS FFR Park SJ, Ahn JM. AMC Registry Data Analysis

41 Cumulative Incidence, % Primary End Point (Death, MI, or Repeat Revascularization) Before Routine Use of FFR After Routine Use of FFR 15 HR (95%CI) 0.55 ( ), p< % 45% 5 4.8% No. at Risk Before Routine Use After Routine Use Propensity Score Matched Population Days Since Procedure

42 PCI vs. CABG in Multi-Vessel Disease, 2013 Evolving Concept of PCI ; More Functional Approach, More Stents Means Just More MACE. Complete Revascularization is Not Always Necessary. Consider Reasonable Incomplete Revascularization. Ischemia Guided PCI is Better. FFR Guided PCI is Better, Consider Integrated Use of FFR and IVUS.

43 Impact of FFR for Multi-Vessel Disease 0VD (9%) 3VD (14%) How Totally many Different patients who World have Only 14% of cases are truly, functionally, functionally 1VD Different significant significant (34%) Concept 2-3 vessel and disease 3 vessel disease! requiring Different surgery Clinical Outcomes real practice!? Angiographic 3 VD (n=115) 2VD (43%) Tonino et al, JACC 2010;55:

44 We Need New Concept of Study, FAME 3 Patients with Positive FFR (<0.80), 2-3 Vessel Disease with or without LM R PCI + OMT CABG Primary Endpoint at 2 years: Death + MI + Repeat R + Stroke

45 PCI vs. CABG in Multi-Vessel Disease, 2013 We need absolutely new data, about the future role of PCI and CABG in functionally, significant multi-vessel disease under the concept of functional approach, integrated use of FFR and IVUS. The Game Is Just Begun!

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