Unprotected LM intervention

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1 Unprotected LM intervention Guideline for COMBAT Seung-Jung Park, MD, PhD Professor of Internal Medicine, Seoul, Korea

2 Current Recommendation for unprotected LMCA Stenosis Class IIb C in ESC guideline (25) and Class III in ACC guideline (26) in patients eligible for CABG Class III is the conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/ effective and in some cases may be harmful.

3 Compare to Surgery, Limited Data High Mortality in PCI?

4 In the era of BMS

5 Study Park et al, 1998 Silvestri et al Park et al Procedural Success (BMS) in Left Main PCI Series Site(s) & WHC Marcielle, France Asian Pacific Multicenter Registry Years Hu More et al than Moriyama, 1,3 Japan patients were included % Pts # Procedure success 1% 1% 98.9% Brueren et al St Antonius Hospital, Nieuwegein, Netherlands % Takagi et al Columbus Hospital and San Raffaele Hospital, Milan % Ellis et al 16 hospitals (ULTIMA Registry) %

6 Low in-hospital Mortality for good candidate for Surgery In-hospital death, % Poor CABG candidates Reasonable CABG candidates Black et al, JACC, 21.

7 Six-Month TLR in PCI Series on Unprotected LM month TLR, % ULTIMA Black Silvestri Park Hu Takagi

8 Long-term Mortality at Follow-up in PCI Series on Unprotected LM 3 F/U mortality, % ULTIMA Black Silvestri Park Hu Takagi F/U duration, mean (months)

9 Multivariate Predictors of All-Cause Mortality: ULTIMA Registry LVEF 3% MR grade 3 or 4 Cardiogenic shock Cr 2mg/dL Severe lesion calcification Tan et al, Circulation, 21

10 Multivariate Predictors of All-Cause MI /Death : AMC data 324 patients who underwent elective coronary stenting for the treatment of unprotected LMCA High EuroSCORE ( 6) No. of total used stents Use of GP IIb/IIIa inhibitor Hazard ratio 95% CI P value <.1 Unpublished AMC data, 26

11 Lessons from data of PCI on unprotected LM (BMS) In the reviewed series, outcomes of PCI are highly correlated with pre-procedure clinical risk profile of the patient (low mortality in low risk patients) Good candidate for surgery is good candidate for PCI

12 Compare to Surgery, Efficacy concerns

13 Included trials: ARTS SoS ERACI-2 MASS-2

14 Four CABG vs. Stent Assisted PCI trials Enrollment period Number of screened pts Number of eligible pts Number of randomized pts Inclusion criteria Exclusion criteria Primary endpoint ARTS NA NA 1,25 Stable and unstable AP, and silent ischemia LMCA stenosis Transmural MI within previous week 12-month MACCE free survival SoS NA NA 988 Stable and unstable AP, and silent ischemia MI within 48 hours Repeat revascularizat ion ERACI ,759 1,76 45 Stable and unstable AP, and silent ischemia MI within 48 hours MACE within 3 days and need for repeat revascularizati on at 3 days MASS ,692 2,76 More than 3, patients were randomized 48 Stable and unstable AP, objective evidence of ischemia LMCA stenosis Composite of cardiac death, MI, and angina requiring revascularization Mercado et al, J thoracic Cardiovasc Surg, 25

15 One-year Rates of Death, MI or Stroke in 4 CABG vs. Stent Assisted PCI Trials Mercado et al, J thoracic Cardiovasc Surg, 25

16 One-year Rates of Repeat Revascularization in 4 CABG vs. Stent Assisted PCI Trials Repeat Revascularization Mercado et al, J thoracic Cardiovasc Surg, 25

17 PCI have comparable clinical outcomes at least one year follow-up period. There is no difference in rates of death, MI or stroke. Repeat revascularization is the only problem in PCI Efficacy concerns of PCI (BMS) for LM disease Compare to surgery

18 In the era of DES

19 * Abstracts In-Hospital Outcomes: DES in Left Main PCI Series Series Procedure success Death Park et al Chieffo et al Valgimigli et al De Lezo et al Gershlick et al Lefevre et al* Costa et al* Nakamura et al* Di Salvo et al* 1% 1% 99% 1.% More than1 patients 96% were included 1% 96.9%.8% 1% 1% 98.7%

20 Angiographic Restenosis in Two DES vs. BMS Left Main PCI Series Restenosis, % BMS DES 3.3 P<.1 7 Restenosis, % P=.18 Seoul Follow-up 6 months Milan 4 to 8 months Park et al, JACC 25 Chieffo et al, Circulation 25

21 Significant Reduction of TLR with DES Unprotected Left main stenting Bare metal stent Repeat revascularization (%) Drug-eluting stent Silvestri ULTIMA Tagaki RESEARCH de Lezo Black Park Chieffo Park

22 Long-term Mortality (after 6 Mo) Acceptable in the patients at a low risk! Long-term mortality (%) Bare metal stent 3.4 Drug-eluting stent * 24.2 * 16.4 * * Ellis Black Park RESEARCH Park Silvestri ULTIMA Tagaki Chieffo de Lezo * High-risk surgical candidates

23 Current data suggested DES are safe in the treatment of LM stenosis While treatment of unprotected LMCA stenosis with PCI remains controversial, improved outcome through reduced recurrence rates may influence opinion away from the surgical towards the percutaneous approach.

24 DES for Ostial or Shaft LMCA Stenosis? AMC data, 26

25 Ostial and Shaft LM PCI 51 patients Lesion length, mm Reference, mm Used stent IVUS guidance Acute gain, mm Late loss, mm Restenosis TLR Stent thrombosis 9.3 ± ±.53 Single in all pts 41 (8%) 2.18 ±.66.1 ±.23 1/38 (2.6%) 1 (2.%) AMC data, 26

26 DES for Ostial or Shaft LMCA Stenosis No Mortality 2.6% Restenosis 2% TLR Would be an effective alternative and even better compare to surgery

27 Just 1-minute work! Do you still prefer surgery?

28 What about DES for Bifurcation LMCA Stenosis? More challenging issue

29 Different treatment strategy for LM bifurcation lesion Colombo A Serruys PW Park SJ Distal location Bifurcation stenting Culotte T technique Crush Kissing 69 (81.2%) 51 (74%) 5 (1%) 4 (8%) 3 (59%) 12 (24%) 65% 4% 36% 44% 12% 8% 72 (7.6%) 29 (41%) 1 (3%) 11 (38%) 17 (59%) TLR 12 (14.1%) 6 (6%) 2 (2.%) Makes diverse TLR rates

30 Recommended Treatment Strategy for LMCA bifurcation lesions Stenting Cross-over (provisional T stenting) Kissing Stenting Stent Crushing

31 Stenting Cross-over over In lesions with normal LCX A B C D LCX Main vessel

32 Kissing Stenting Lesions with large LM and diseased LCX A B C D

33 Stent Crushing In moderate sized LM and diseased LCX A B C D LCX Main vessel

34 Different Treatment Strategy According to LM size and LCX involvement Across LCX Crush Kissing Diameter stenosis of LCX (%) Small LM LCX disease % 2 % 58 % Small LM Big LM LCX disease - LCX disease Reference diameter of LMCA (mm) Big LM LCX disease +

35 % 15 1 Restenosis Rate of 124 LM Bifurcation PCI Main Vessel P=.28 4/98 /57 4/41 Overall Cross-over Complex

36 Restenosis Rate of 124 LM Bifurcation PCI % 2 LCX P= /98 3/57 7/41 Total Cross-over Complex

37 Restenosis Rates and TLR Overall LM bifurcation PCI % 3 2 Restenosis rate TLR P=.24 in restenosis P=.76 in TLR /98 9/124 3/57 2/69 1/41 7/55 Total Cross-over Complex

38 Two Different Complex Strategies Kissing vs. Stent Crushing

39 QCA at Main Vessel Patients Follow-up CAG Proximal RVD, mm Distal RVD, mm MLD, mm Before procedure After procedure At follow-up Lesion length, mm Acute gain, mm Late loss, mm Restenosis Kissing stenting 24 2 (83) 4.9± ±.42.91± ± ± ± ±.4.39±.67 3 (15.) Stent Crushing p (84) 3.46± ± ± ± ± ± ± ± (4.8) 1. YH Kim, Am J Cardiol 26 (in press)

40 QCA at LCX Kissing stenting Stent Crushing p Patients Follow-up CAG 2 (83) 21 (84) Distal RVD, mm 2.73± ± MLD, mm Before procedure 1.48± ± After procedure 2.7± ± At follow-up 2.3± ± Acute gain, mm 1.22± ± Late loss, mm.72±.56.67± Restenosis 3 (15.) 4 (19.) 1. YH Kim, Am J Cardiol 26 (in press)

41 % 4 Kissing vs. Crush Restenosis Rate Kissing (N=2) Crushing (N=21) 3 Kiss+ 1 Kiss P= Kiss+ P=.343 P= Overall Main vessel Side branch

42 TLR : 7.3% in LM Bifurcation PCI 9/124 patients 2 % 2 TLR 1 CABG 1 Cutting 3 TLR 2 CABG 1 Cypher 4 TLR 1 CABG 2 Cutting 1 Cypher (2.9%) 2 (7.4%) 1 (4.1%) 1 (3.6%) Simple Kissing Crushing (N=69) (N=27) (N=28) 3 (1.7%) LCX side LAD main

43 Lessons from AMC data for LM Bifurcation PCI Both the presence of ostial LCX disease (diameter stenosis 5%) and the LMCA size by angiographic and IVUS examinations were two important considerations in selecting the stenting strategy. Compared to the complex stenting approach, the simple approach (stenting cross-over) was technically easier and appeared to be more effective in improving long-term outcomes for lesions with normal or diminutive LCX.

44 Compare to Surgery, Efficacy concerns of PCI with DES

45 COMBAT Randomized Trial COMparison of Bypass surgery and AngioplasTy using sirolimus electing stent in patients with left main coronary disease Left Main disease with or without MVD Up to 75 cardiac centers Randomize over 1,776 (1:1) Registry group 1, PCI with SES N=888 CABG N=888 CABG PCI Medication Primary Endpoint: 2-year death, MI, and stroke Key Secondary Endpoints: MACCE including primary end point and ischemia-driven TLR PI: Seung-Jung Park, Martin B. Leon

46 Inclusion Criteria At least 18 years of age LM stenosis > 5% by visual estimate Patients with angina or documented ischemia, amendable to both stent-assisted PCI or bypass surgery Lesions outside LMCA potentially treatable with both PCI and CABG Agreement to informed written consent

47 Pre-COMBAT Preliminary analysis Data from 7 centers in Korea, for the last 12 months

48 Pre-COMBAT Run-in study From December 24 to December 25 Randomized group N=151 Registry group N=254 PCI N=76 CABG N=75 PCI N=81 CABG N=159 Medication N=14 Randomization : Registry = 2 : 3 PCI in registry : CABG in registry = 1 : 2

49 Randomization Group Baseline Characteristics SES N=76 CABG N=75 P value Age (years) 58±1 6±1.193 Men 54 (71%) 55 (73%).857 Unstable angina 26 (34%) 3 (4%).319 Past history Previous MI 3 (4%) 6 (8%).32 Previous PCI 1 (1%) 5 (7%).156 History of CVA 8 (11%) 3 (4%).29 History of chronic lung disease 3 (4%) 2 (3%) 1. Renal insuff. (Cr 1.3mg/dL) 4 (5%) 5 (7%).742

50 Randomization Group Baseline Characteristics SES N=76 CABG N=75 P value Risk factors Hypertension 38 (5%) 43 (57%).264 DM 23 (3%) 23 (31%).865 Current smoking 3 (4%) 32 (43%).582 Hypercholesterolemia 23 (3%) 23 (31%).86 Family history of CAD 11 (15%) 9 (12%).72 Peripheral vascular disease 1 (1%) 2 (3%).513 LV ejection fraction (%) 63±7 6±9.156

51 Procedural Data Randomization Group SES N=76 CABG N=75 P value Involvement of RCA 35 (46%) 36 (48%).658 Lesion site.684 Ostium 19 (25%) 17 (23%) Shaft 9 (12%) 6 (8%) Bifurcation 48 (63%) 52 (69%) Days after randomization till OP 2.4±6.6 6.± Use of IABP 2 (3%) 9 (12%).27 Use of GP IIb/IIIa inhibitor 4 (5%) 1 (1%).366

52 Procedural Data Bifurcation stenting Stenting crossover circumflex Provisional T stenting Crush technique Kissing stenting Others Number of used stents at LM Number of total used stents Extra-LM PCI IVUS guidance Use of off-pump Number of total conduits Number of arterial conduits SES N=76 24 (5%) 1 (2%) 1 (21%) 11 (23%) 2 (4%) 1.4±.6 2.5± (59%) 65 (86%) Randomization Group CABG N=75 38 (51%) 2.5± ±.9

53 In-hospital Outcome Randomization Group Death Cardiac ST elevation MI Non-ST elevation MI Stroke Repeat revascularization PCI CABG Stent thrombosis MACCE SES N=76 Non-cardiac 1 (1%) Myocardial infarction 2 5 (7%) 8 (11%) 5 (7%) 5 (6.6%) CABG N=75 1 (1%) 1 3 (4%) 5 (7%) 9 (12.%) P value Pneumonia after CABG, 2 CK-MB 3 times normal in PCI and 1 times normal in CABG

54 Additional MACCE at 9 months Randomization Group SES N=24 CABG N=25 P value Death Cardiac Non-cardiac 1 Myocardial infarction ST elevation MI Non-ST elevation MI Stroke Repeat revascularization 2 (8%) 1 (4%).356 PCI 2 1 CABG Stent thrombosis

55 Registry Group Primary reason of exclusion from randomization Patient s or doctor s preference Complex lesion, not suitable for stenting Chronic total occlusion Previous PCI within 1 year Acute STEMI Renal failure Age more than 8 years Disabled CVA Emergent CABG Bail-out PCI Patients who need major surgery PCI group N=81 54 (67%) 3 (4%) 7 (9%) 5 (6%) 4 (5%) 3 (4%) 1 (1%) 1 (1%) 6 (4%) CABG group N= (14%) 89 (57%) 29 (19%) 1 (1%) 1 (1%) 2 (1%) 2 (1%) 4 (3%) 1 (1%)

56 Baseline Characteristics Registry Group SES N=81 CABG N=159 P value Age (years) 63±11 64±8.682 Men 56 (69%) 123 (77%).167 Unstable angina 2 (25%) 58 (36%).43 Past history Previous myocardial infarction 9 (11%) 22 (14%).528 Previous PCI 15 (19%) 18 (11%).17 Previous CABG 1 (1%).337 History of CVA 8 (1%) 16 (1%).943 History of chronic lung disease 7 (9%) 11 (7%).645 Carotid end arterectomy 1 (1%).291 Renal insuff. (Cr 1.3mg/dL) 1 (12%) 19 (12%).919

57 Baseline Characteristics Registry Group Risk factors SES N=81 CABG N=159 P value Hypertension 37 (46%) 85 (53%).162 Diabetes 21 (26%) 57 (36%).87 Current smoking 29 (36%) 72 (45%).16 Hypercholesterolemia 18 (22%) 34 (21%).89 Family history of CAD 7 (9%) 18 (11%).488 Peripheral vascular disease 5 (6%) 4 (3%).28 LV ejection fraction (%) 6.8± ±12.1 <.1

58 Procedural Data Registry Group SES CABG P value N=81 N=159 Involvement of RCA 22 (27%) 124 (78%) <.1 Lesion site <.1 Ostium 26 (32%) 14 (9%) Shaft 8 (1%) 15 (9%) Bifurcation 47 (58%) 13 (82%) Days after random till OP 5.3± ±2.8 Use of IABP 6 (7%) 14 (9%).553 Use of GP IIb/IIIa inhibitor 5 (3%).169

59 Procedural Data Bifurcation stenting Stenting crossover circumflex Crush technique Kissing stenting T stenting Others Number of used stents at LM Number of total used stents Extra-LM PCI IVUS guidance Use of off-pump Number of total conduits Number of arterial conduits SES N=81 16 (34%) 13 (28%) 15 (32%) 1 (2%) 2 (4%) 1.2±.4 2.2± (6%) 52 (64%) Registry Group CABG N= (41%) 3.1±.9 2.5±.9

60 In-hospital Outcome Registry Group Death Cardiac Non-cardiac Myocardial infarction ST elevation MI Non-ST elevation MI Stroke Repeat revascularization PCI CABG Stent thrombosis MACCE SES N=81 2 (2%) 2 (2%) 8 (1%) 2 (3%) 6 (7%) 1 (1%) 1 (1%) 1 (1%) * 8 (9.9%) CABG N=159 4 (3%) 4 (3%) 35 (22%) 7 (4%) 28 (18%) 3 (2%) 38 (23.9%) * Acute stent thrombosis after primary stenting for acute STEMI P value

61 Summary of Pre-COMBAT Run-in Study About 2/5 of all LMCA patients has been randomized. Bifurcation lesions were included in 2/3 of all LMCA disease. Complex stenting techniques were used in a half of LMCA bifurcation PCIs. Arterial grafts were used in 2/3 of all grafts (LIMA in 98%) The initial outcomes of PCI and CABG appears to be comparable. Peri-operational MI tends to occur more commonly in the CABG group.

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