PCI Update Qesaria 2009

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1 PCI Update Qesaria 2009 Amit Segev Interventional Cardiology Chaim

2 Outline Primary PCI Non-ST elevation ACS Multi-vessel disease Hemodynamic assessment of borderline lesions - FFR Stable AP Non-coronary interventions - TAVI

3 23 Randomized Studies of Primary PCI vs. Lysis n=7739 Keeley et at, Lancet 2003

4 The RIKS The RIKS-HIA Registry Consecutive pts admitted in 75 of 78 hospitals with CCUs in Sweden Stenestrand U et al. JAMA 2006

5 The RIKS-HIA Registry Stenestrand U et al. JAMA 2006

6 The RIKS-HIA Registry Stenestrand U et al. JAMA 2006

7 How Late After Symptom Onset Does Opening the Infarct Related Artery Still Provide Benefit?

8 Survival of Myocardium Fraction of ischemic cells already dead Hours of Ischemia

9 BRAVE II : Efficacy of Late Primary PCI Schomig A et al. JAMA 2005

10 BRAVE 2 Infarct Size at 7 days Schomig A et al. JAMA 2005

11 BRAVE 2 30 day End-points Schomig A et al. JAMA 2005

12 What is the optimal device / drug for primary PCI?

13 9 DES vs. BMS RCTs in AMI (N=3,728 patients) Stone G. Fellows Course 2008

14 7 DES vs. BMS RCTs in AMI (n=2,357) TLR at 8 12 Months Pasceri V et al. AHJ 2007

15 7 DES vs. BMS RCTs in AMI (n=2,357) Stent Thrombosis at 8 12 Months Pasceri V et al. AHJ 2007

16 The Spanish ESTROFA Registry 23,500 pts treated w/des at 20 Spanish hospitals from ; 63% PES, 37% SES. Dual antiplatelet Rx for 8±3 months. 1.3% ST rate at median FU 22 (11, 32) mos ; 2.0% ST at 3 yrs De la Torre Hernandez J et al. JACC 2008

17 The Spanish ESTROFA Registry Multivariate Predictors of Stent Thrombosis (n=14,120) De la Torre Hernandez J et al. JACC 2008

18 The Spanish ESTROFA Registry Multivariate Predictors of Stent Thrombosis (n=14,120) De la Torre Hernandez J et al. JACC 2008

19 Is thrombus retrieval useful during primary PCI? Distal Protection and Thrombectomy in AMI - Macroscopic embolic debris can be retrieved from >75% of cases

20 Myocardial Blush-3 Flow: 15 RCTs De Luca G et al. AHJ 2007

21 Mortality at 30 Days: 18 RCTs De Luca G et al. AHJ 2007

22 TAPAS: 1,071 pts with STEMI undergoing primary PCI at a single center were randomized in the ER to manual aspiration (Export) vs. control Svilaas T et al. N Engl J Med 2008

23 TAPAS: 1,071 pts with STEMI undergoing primary PCI at a single center were randomized in the ER to manual aspiration (Export) vs. control Svilaas T et al. N Engl J Med 2008

24 What is the Optimal anti- Thrombotic Regimen in Primary PCI?

25 Abciximab in Primary PCI Meta-analysis 8 RCTs 3,949 pts with AMI w/i 12 undergoing primary (7) or rescue (1) PCI rand to abciximab vs. placebo De Luca G et al. JAMA 2005

26 HORIZONS-AMI Stone G et al. N Engl J Med 2008

27 HORIZONS-AMI Primary End-points Stone G et al. N Engl J Med 2008

28 HORIZONS-AMI Major bleeding (non-cabg) Stone G et al. N Engl J Med 2008

29 HORIZONS-AMI Mortality Stone G et al. N Engl J Med 2008

30 HORIZONS-AMI Stent Thrombosis Stone G et al. N Engl J Med 2008

31 Clinical events in the HORIZONS-AMI pharmacology arm at two years End point Bivalirudin, n=1800 (%) Heparin plus GP IIb/IIIa inhibitor, n=1802 (%) Hazard ratio (95% CI) Major bleeding, non-cabg All-cause mortality Cardiac mortality ( ) ( ) ( ) Reinfarction ( ) ARC definite or probable stent thrombosis ( ) Stone G. TCT 2009; September 21-25, 2009; San Francisco, CA.

32 Clinical and safety events in the HORIZONS-AMI stent arm at two years End point Taxus, n=2257 (%) Express baremetal stent, n=749 (%) Hazard ratio (95% CI) Ischemic target lesion revascularization MACE (death, reinfarction, stroke, stent thrombosis) ( ) ( ) All-cause mortality ( ) ARC definite or probable stent thrombosis ( ) Stone G. TCT 2009; September 21-25, 2009; San Francisco, CA.

33 NSTE-ACS

34 A case of ACS 76 year old woman presents to ER with shoulder discomfort Chronic risk factors: hyperlipidemia,, type II diabetes, HTN, chronic renal insufficiency Left shoulder pain improved with movement, massage therapy. Similar symptoms on exercise bike, resolves after 10 minutes Exam: HR 90, BP 118/70; crackles at both lung bases Labs: creatinine 1.7 mg/dl dl,, Troponin T 0.32

35 A case of ACS

36 According to GRACE score, what is her in-hospital and 6-month 6 mortality rate? 2-3% and 5% 5% and 9% 10% and 15% 20% and 30%

37 GRACE Score

38 GRACE Score

39 Selection of Initial Treatment Strategy: Invasive Versus Conservative Strategy UA/NSTEMI ACC/AHA guidelines. Circulation 2007

40 Non STE ACS Early Versus Invasive What s s new?

41 Randomized Trials in NonSTMI: Relative reduction in composite outcome and absolute difference in mortality Bogarty et al. Lancet 2003

42 Early Invasive vs Selective Invasive Meta-analysis, average 2 year follow-up Bavry et al. JACC 2006

43 ICTUS 4 year follow-up Lancet 2007

44 ICTUS Revascularization Lancet 2007

45 Bivalirudin

46 ACUITY Study 13,809 pts with mod-high risk ACS undergoing early invasive therapy Heparin + GPIIb/IIIa Bivalirudin + GPIIb/IIIa Bivalirudin alone Stone G et al. N Engl J Med 2006

47 ACUITY: 30 day outcome Stone G et al. N Engl J Med 2006

48 ACUITY - 30 day outcome

49 Acuity - Subgroup analysis Stone G et al. N Engl J Med 2006

50 ACUITY - Subgroup analysis Stone G et al. N Engl J Med 2006

51 Multi-Vessel Disease

52 SYNTAX Score

53 SYNTAX Trial Serruys PW et al. N Engl J Med 2009

54 SYNTAX Trial Serruys PW et al. N Engl J Med 2009

55 SYNTAX Trial Serruys PW et al. N Engl J Med 2009

56 SYNTAX Trial Serruys PW et al. N Engl J Med 2009

57 SYNTAX 12 Mo. Death / CVA / MI in LM Subset CABG TAXUS LM all (n=705) LM only (n=91) LM+1VD (n=138) LM+2VD (n=218) LM+3VD (n=258)

58 The Revival of FFR

59 FAME Study Primary EP - Composite of death, myocardial infarction, or repeat revascularization ( MACE ) at 1 year Tonino P et al. N Engl J Med 2009

60 FAME Study Tonino P et al. N Engl J Med 2009

61 FAME Study Tonino P et al. N Engl J Med 2009

62 FAME Study Tonino P et al. N Engl J Med 2009

63 SYNTAX Vs. FAME

64 PCI in Stable Angina

65 COURAGE Patients Screening COURAGE Trial. N Engl J Med 2007

66 COURAGE Nuclear Substudy COURAGE Trial. Circulation 2008

67 COURAGE Outcome by residual ischemia COURAGE Trial. Circulation 2008

68

69

70 Patients with Obstructive Coronary Artery Disease, According to Noninvasive Test Result

71

72 Trans-Catheter Aortic Valve Implantation (TAVI) Edwards Trans-femoral Trans-apical CoreValve Trans-femoral

73 High Risk AS Patients Octogenarians with multiple co-morbidities COPD Diabetes PVD Reduced LVEF Renal failure Previous cardiac surgery Euroscore >20% (~10% days) STS >10%

74 Inoperable AS Patients Radiation chest wall / heart disease Severe chest wall deformities End-stage COPD Cirrhosis with portal hypertension Porcelain aorta (CT proven) Degenerative neurocognitive dysfunction High frailty index (qualitative assessment) >50% chance of mortality or never leaving a chronic care facility Surgeons are gatekeepers!!!

75 At least 30% of severe AS pts. are untreated

76 First Generation Devices Edwards >2500 patients CoreValve >2500 patients

77 Pre-procedural Assessment Clinical cardiologist and surgeon Echocardiography Measurements Confirmatory TEE if necessary Angiography Do any PCI before Aortic injection Iliac / femoral angiography CTA if needed Any PCI should be done before!

78 Deployment of ProStar Closure Device Over 9Fr sheath

79 Balloon Valvuloplasty During rapid pacing (170/min) Extra-stiff guide-wire

80 Positioning of CoreValve Line #2 at annulus

81 Opening of Ventricular Segment of CoreValve

82 Opening of Aortic Segment of CoreValve - still retrievable!!

83 CoreValve Fully Deployed Mild AR

84 PARTNER Study

85

86 OUTCOMES

87

88

89

90 תודה ובה צלח הה!

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