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La preparazione all’ angioplastica nello STEMI

La preparazione all’ angioplastica nello STEMI. Stefano Savonitto. CORSO AREA EMERGENZA-URGENZA ANMCO. Roma, 20 Marzo 2010. www.degasperis.it. Questa presentazione sarà disponibile al più presto sul sito della Fondazione De Gasperis nella sezione Area Medici. ESC PCI guidelines 2005.

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La preparazione all’ angioplastica nello STEMI

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  1. La preparazione all’ angioplastica nello STEMI Stefano Savonitto CORSO AREA EMERGENZA-URGENZA ANMCO Roma, 20 Marzo 2010

  2. www.degasperis.it Questa presentazione sarà disponibile al più presto sul sito della Fondazione De Gasperis nella sezione Area Medici

  3. ESC PCI guidelines 2005 STEMI < 12h after onset of chest pain Patient presenting in a hospital with PCI Patient presenting in a hospital without PCI > 3-12h < 3 h Especially if thrombolysis is contraindicated or at high risk transfer Thrombolysis failed successful PCI not within 24h available PCI within 24h available Predischarge Ischemia Primary PCI Rescue PCI Prognostic PCI Ischemia-driven PCI

  4. STEMI 2008 GL update Reperfusion First Medical Contact (FMC) Time limits PCI-capable hospital‡ Ambulance Non-PCI-capable hospital PCI <2h possible* 2h Primary PCI Pre-, in-hospitalfibrinolysis PCI <2h not possible† 12h failed successful Rescue PCI Angiography§ 24h *Time FMC to first balloon inflation must be shorter than 90 min in patients presenting early (< 2 h after symptom onset), with large amount of viable myocardium and low risk of bleeding. †If PCI is not possible <2 h of FMC, start fibrinolytic therapy as soon as possible §Not earlier than 3 hafter start fibrinolysis ‡24/7 service STEMI 2008 GL update Eur Heart J 2008;29:2909-45

  5. FIC Year 2005 census of Italian Cardiological Facilities 2005 2000 411 CCU (2573 beds) 380 236 (57%) CCU + on-site Cath Lab 151 (41%) 213 (52%) CCU + on-site interventional cathlab 111 (29%) 143 (35%) CCU + on-site interventional cathlab H24 64 (17%) Only 1/3 of the CCUs are PCI-capable around-the-clock! De Luca L, et al. GIC 2008; 9 (suppl.1-5): 5S-83S

  6. Ischemia Time Relationship in Primary PCI Y = 2.86 (±1.46) + 0.0045X1 = 0.000043X2 P<0.001 De Luca G, Circulation 2004;109:1224

  7. Effect of Time to PCI on 6 Month Mortality Low Risk High Risk P=0.04 P=NS N=394 N=942 Antoniucci, AJC 2002; 89:1248 + age < 70 yrs, non-ant MI, HR <100

  8. The Bologna STEMI Network Pre-Hospital resource utilization P< 0.0001 P< 0.0001 59% 49% 45% 0% Telemedicine 118 EMS Saia F, et al. Heart 2009; 95:370-376

  9. EUROTRANSFER Registry: 7 European countries 2005 - 2007 Diagnosis To Balloon Time (%) In 1650 pts with STEMI Dudek D et al. ESC 2007

  10. Implementation of reperfusion in STEMI: ESC policy statement “Thrombolytic rx is a valid option if PPCI cannot be delievered in a timely manner, particularly within the first 3 h after symptom onset. Prehospital thrombolysis MUST BE preferred over in-H thrombolysis.” Bassand JP et al, Eur Heart J 2005;26:2733-41

  11. Trials of Pre-hospital Fibrinolysis Mortality ReductionOdds Ratio and 95% CI MinSaved PrehospitalBetter PrehospitalWorse N Lytic EMIP 5,469 APSAC 55 MITI 360 t-PA 33 GREAT 311 APSAC 130 Roth 116 t-PA 43 Schofer 78 UA 52 Castaigne 100 APSAC 60 Pooled 6,434 RR 17%  58 P = .03 0.0 0.5 1.0 1.5 2.0 Adapted from, LJ Morrison JAMA 2000

  12. 1-year adjusted survival in STEMI 1995 - 2004 1995 - 2004 No reperfusion trt In-hosp reperfusion trt Pre-hosp reperfusion trt Primary PCI JAMA 2006;296:1749-1756 Days Uppsala Clinical Research Centre 2005

  13. Five-year follow-up of the CAPTIM study # deaths lys/PCI pre-hosp lysis PPCI HR (95% CI) P-value <2h >2h Pre-hospital lysis Primary PCI Pre-hospital lysis Primary PCI <2h >2h Bonnefoy E. Eur Heart J 2009;30:1598-1606

  14. 8 7 7 7 6 6 5 5 4 4 3 3 2 2 1 0,1 0 Death Re-MI Re-TLR Stroke ASSENT-4: premature discontinuation after 1667 patients Primary PCI (838 Pts) Full Dose TNK + PCI (829 pts) P= 0.14 P= 0.19 P= 0.004 P< 0.0001 P=0.14 P=0.19 P=0.004 P<0.0001 90 Day Event Rate (%) Van de Werf F for the ASSENT 4 PCI Investigators, Lancet 2006; 367:569-78

  15. IRA patency (TIMI flow 2+3) pre-PCI After combo facilitation therapy CumulativeTIMI 2+3 at initial angio 100- 90- 80- 70- 60- 50- 40- 30- 20- 10- 0- FINESSANGIO ESC 2009 Manari IHJ 2002 Politi IHJ 2003 CARESS Lancet 2008

  16. TIMI flow 3 rates pre-PCI In the FINESSANGIO corelab 100- 90- 80- 70- 60- 50- 40- 30- 20- 10- 0- 76 43 32 Pre-cathlab Combo therapy Cathlab abciximab Pre-cathlab abciximab Prati F. ESC congress 2009

  17. TIMI flow 3 rates post-PCI In the FINESSANGIO corelab 100- 90- 80- 70- 60- 50- 40- 30- 20- 10- 0- 80 78 77 Pre-cathlab Combo therapy Cathlab abciximab Pre-cathlab abciximab Prati F. ESC congress 2009

  18. MBG 3 rates post-PCI In the FINESSANGIO corelab 100- 90- 80- 70- 60- 50- 40- 30- 20- 10- 0- 86 86 80 Pre-cathlab Combo therapy Cathlab abciximab Pre-cathlab abciximab Prati F. ESC congress 2009

  19. Primary endpoint p=0.55 Ellis S, NEJM 2008; 358:2205-17

  20. 1-Year mortality follow-up AnteriorMI 1-year mortality anterior MI % Infarct size anterior MI AUC CK release (IU/L/h) 12- 11- 10- 9- 8- 7- 6- 5- 2000- 1900- 1800- 1700- 1600- 1500- 1400- 1300- <0.001 OR 0.65 (0.39-1.08) P=0.09 0.01 Cathlab abx Pre-Cath abx Pre-Cath combo Cathlab abx Pre-Cath abx Pre-Cath combo Ellis S, JACC Interventions 2009 Oct;2(10):909-16

  21. Benefit of facilitated PPCI in high-risk patients presenting at non-PCI centers 1-year mortality A: all pts N= 2,452 C: TRS>3 spoke site N= 502 16.0% 13.3% B: TRS>3 N= 1,229 D: TRS>3 spoke site symptom to rand. < 4h N= 397 6.6% Herrmann HC. JACC Interventions 2009;2:917-24

  22. Nonintracranial bleeding p<0.001 p<0.001 p=0.025 p=0.008 p=0.006 p=0.547 p=0.025 p=0.141 p=0.127 Ellis S, NEJM 2008; 358:2205-17

  23. Additive effect of streptokinase and aspirin ISIS-2: Lancet 1988;2:349-60

  24. Thienopyridine pretreatment ACC/AHA STEMI/PCI 2009 GL update Circulation 2009;120:2271–306

  25. Evidence-basedwhat? • The optimum loading dose ofclopidogrelhasnotbeenestablished. • Randomizedtrialsestablishingitsefficacy and providing data on bleedingrisksused a loading dose of 300 mg orallyfollowedby a dailyoral dose of 75 mg (CURE and CLARITY). • Higheroralloadingdosessuchas 600 mg or more than 900 mg ofclopidogrel more rapidlyinhibitplateletaggregation and achieve a higherabsolutelevelofinhibitionofplateletaggregation, but the additive clinicalefficacy and safetyofhigheroralloadingdoseshavenotbeenrigorouslyestablished. • The necessityforgiving a loading dose ofclopidogrelbefore PCI isdrivenby the pharmacokineticsofclopidogrel, forwhichseveralhoursare requiredtoachievedesiredlevelsofplateletinhibition. • Forpost-PCIpatientsreceiving a stent (BMS or DES), a dailymaintenance dose shouldbegivenfor at least 12 months and for up to 15 monthsunless the riskofbleedingoutweighs the anticipated net benefit affordedby a thienopyridine. ACC/AHA STEMI/PCI 2009 GL update Circulation 2009;120:2271–306

  26. The clopidogrelpretreatment saga Kastrati A. ISAR-REACT 3 study

  27. Clopidogrel Pre-Treatment and Myocardial Damage After Elective Stenting N = 203 van der Heijden et al. JACC 2004; 44:20

  28. Clopidogrel Pre-Treatment and Myocardial Damage After Elective Stenting N=203 (3 days) van der Heijden et al. JACC 2004; 44:20

  29. Periprocedural MI after PCI. The randomized ARMYDA-2 trial 75% 25% Excluded: SVG CKMB elev STEMI Patti G et al, Circulation 2005

  30. Periprocedural MI after PCI The randomized ARMYDA-2 trial P<.05 15 casi 5 casi CKMB x 3 ULN Patti G et al, Circulation 2005

  31. Periprocedural MI after PCI. The CKMB and PCI study Frequenciesof CK-MB elevationsbyintervals (N=3494) 5.7% Cavallini C. Eur Heart J 2005;26;1494–1498

  32. Impact of abciximab on top of ASA and clopidogrel Death or MI at 30 days 20- 18- 16- 14- 12- 10- 8- 6- 4- 2- 0- 18.3 P=0.02 13.1 P=0.91 P=0.98 4.6 4.6 4.0 4.0 Placebo Abciximab Placebo Abciximab Placebo Abciximab ISAR REACT 2 TnT negative ISAR REACT 2 TnT positive ISAR REACT 1 Kastrati A, NEJM 2004, JAMA 2006

  33. ARMYDA-5: Study design 30 days Medical Rx N= 53 Clopidogrel 600 mg given 4-8 hrs before angio N= 218 N= 350 438 Patients with PCI 600 mg Preload N= 174 Primary end point: Death, MI*, TVR - Stable angina or Angiography Randomization - NSTE ACS PCI 600 mg in-lab N= 176 Clopidogrel 600 mg at the time of PCI N= 220 undergoing coronary angiography CABG N= 35 1st blood sample before PCI 2nd and 3rd blood sample at 8 and 24 hours * MI defined as >3 times UNL post-procedural elevation of CK-MB - CK-MB, troponin-I, myoglobin, CRP Di Sciascio G, et al. ACC 2008

  34. ARMYDA-5 “PRELOAD” Secondary end points Post-procedural CK-MB and Troponin-I elevation above UNL P=0.30 47 P=0.90 39 31 33 % of patients with elevation CK-MB Tn-I Di Sciascio G, et al. ACC 2008

  35. Clopidogrel: Double vs Standard Dose Definite Stent Thrombosis (Angio confirmed) Mehta S, ESC 2009 Clopidogrel 300 + 75 mg 0.012 42% RRR 0.008 Cumulative Hazard Clopidogrel 600 + 150 mg 0.004 HR 0.58 95% CI 0.42-0.79 P=0.001 0.0 0 3 6 9 12 15 18 21 24 27 30 Days

  36. Clopidogrel discontinuation and incidence of stent thrombosis after PCI in the ISAR studies Cumulative incidence of stent thrombosis in patients who continued (black) and those who discontinued clopidogrel (red). Patients switched from one group to the other as soon as they stopped taking clopidogrel. Schulz S. Eur Heart J 2009;30:2714

  37. Inhibition of Platelet Aggregation (Stable Atherosclerosis) 70 Maintenance dose (MD) Loading dose (LD) 60 50 40 Mean IPA (%) 30 20 Prasugrel (40 mg LD/5 mg MD) Prasugrel (40 mg LD/7.5 mg MD) 10 Prasugrel (60 mg LD/10 mg MD) 0 Prasugrel (60 mg LD/15 mg MD) Clopidogrel (300 mg LD/75 mg MD) - 10 7/1 7/2 1/0 1/2 1/4 1/6 28/0 28/2 28/4 28/6 Day/Hour Post Dosing Jernberg, T et al EHJ 2006

  38. Clopidogrel Prasugrel 3 2.8 2.4 p=0.02 RRR=42% 2 p=0.008 RRR=51% 1.6 Proportion of patients (%) 1.2 1 HR=0.58 (0.36–0.93) NNT=83 0 Age-adjusted HR=0.59 (0.37-0.96) 0 100 200 300 400 Time (Days) Stent thrombosis after PPCI in STEMI (ARC Definite/probable) Montalescot G. Lancet 2009;373:723-31

  39. Clopidogrel Prasugrel p= 0.002 10 p= 0.004 p= 0.02 8 p= 0.01 6 Proportion of population (%) 4 p= 0.008 p= 0.04 p= 0.13 2 0 All Death MI UTVR Stent Thrombosis* CV Death/MI CV Death/ MI/UTVR CV Death/ MI/Stroke Efficacy endpoints at 30 daysSTEMI cohort (N=3534) * ARC def/probable Montalescot G. Lancet 2009;373:723-31

  40. Ticagrelor vs clopidogrel: time course of IPA by 20 mM/L ADP Gurbel P. Circulation 2009, published online Nov 19

  41. EGYPT METANALYSIS Pre-Procedural TIMI 3 Flow 23% vs. 13.3% p<0.001 De Luca G, Heart 2008; 94: 1548–1558

  42. One-year Survival 100 Reflow (5.5%) 95 90 Probability of survival (%) No-reflow (16.7%) 85 80 Hazard Ratio = 3.35, 95 CI 1.97-5.69; P<0.001 75 70 0 1 2 3 4 5 6 7 8 9 10 11 12 Numbersat Risk Months 959 929 Reflow 943 1032 1003 990 976 No-reflow 108 95 95 90 88 87 86 Ndrepepa et al. Circ Cardiovasc Interv. 2010;3-27-33.

  43. V ariable No - reflow R e flow P value (n =108) (n =1032) Left ventricular ejection fraction (%) 48.0 [32.8; 56.9] 50.0 [42.0; 58.0] 0.028 Number of narrowed coronary 0.57 arteries 1 39 ( 36.1) 364 (35.3) 2 29 (26.9) 325 (31.5) 3 40 (37.0) 343 (33.2) Pre - intervention TIMI flow grade <0.001 0 90 (83.3) 564 (54.6) 1 5 (4.6) 109 (10.6) 2 10 (9. 3) 189 (18.3) 3 3 (2.8) 170 (16.5) Vessel size (mm) 3.02 [2.65; 3.34] 2.93 [2.58; 3.25] 0.28 Angiographic Data Data are median [25th; 75th %] or number of patients (%) Type of intervention 0.9 6 Stenting 88 (81.5) 843 (81.7) Balloon angioplasty 20 (18.5) 189 (18.3) Pre - procedural abciximab therapy 84 (77.8) 80 0 (77.5) 0.95 Ndrepepa et al. Circ Cardiovasc Interv. 2010;3-27-33

  44. Abciximab for primary PCI in STEMIsignificant mortality reduction -29% De Luca G, et al. JAMA 2005;293:1759

  45. Acute myocardial infarction diagnosed in ambulance or referral center ASA+600 mg Clopidogrel Placebo Tirofiban * Angiogram Angiogram Tirofiban provisional Tirofiban cont’d Study Design On-TIME-2 Van’t Hof AWJ, Lancet 2008; 372: 537-46 Transportation PCI centre PCI *Bolus: 25 µg/kg & 0.15 µg/kg/min infusion

  46. On-TIME-2 Van’t Hof AWJ, Lancet 2008; 372: 537-46 Ischemic Time N=414 N=984

  47. Effect on different End Points On-TIME-2 Van’t Hof AWJ, Lancet 2008; 372: 537-46 Surrogate End Points Clinical End Points

  48. All-Cause Mortality 1-Year On-TIME-2 Hamm C, ACC 2009 open label & double-blind, n = 1398

  49. Early GPIIb/IIIa in STEMI: Bologna STEMI network Ortolani P. Eur Heart J 2009; 30, 33–43 1357 pts underwent PPCI without thrombolysis pre-treatment 2006 2003 - 233 pts no IIb/IIIa administr. 1124 pts treated with IIb/IIIa agents 380 pts “early admistration” 744 pts “late admistration” Primary end-point: Death and re-MI at follow-up Abciximab 0.25 mg/Kg; 0.125μg/Kg/min; Tirofiban 10 μg/Kg or 25 μg/Kg 0.15 μg/Kg/min

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