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Preparazione Farmacologica alla PCI Primaria. Dalle Linee Guida ai Dati Degli Studi e dei Registri: sul Territorio

Convegno Area Emergenza-Urgenza ANMCO Preparazione alla PTCA nelle Sindromi Coronariche Acute Firenze, 23 Gennaio 2010. Preparazione Farmacologica alla PCI Primaria. Dalle Linee Guida ai Dati Degli Studi e dei Registri: sul Territorio. Leonardo De Luca, M.D., Ph.D., F.A.C.C.

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Preparazione Farmacologica alla PCI Primaria. Dalle Linee Guida ai Dati Degli Studi e dei Registri: sul Territorio

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  1. Convegno Area Emergenza-Urgenza ANMCO Preparazione alla PTCA nelle Sindromi Coronariche Acute Firenze, 23 Gennaio 2010 Preparazione Farmacologica alla PCI Primaria. Dalle Linee Guida ai Dati Degli Studi e dei Registri: sul Territorio Leonardo De Luca, M.D., Ph.D., F.A.C.C. Department of Cardiovascular Sciences Interventional Cardiology Unit European Hospital Rome, Italy leo.deluca@libero.it Conflict of interest: none

  2. FactorsAssociatedwithDelays in MechanicalReperfusionTx Cath Lab Symptoms onset and identification Call EMS Pre-hospital phase ER Increasing Loss of Myocytes

  3. FactorsAssociatedwithDelays in MechanicalReperfusionTx Cath Lab Symptoms onset and identification Call EMS Pre-hospital phase ER Increasing Loss of Myocytes

  4. FactorsAssociatedwithDelays in MechanicalReperfusionTx Cath Lab Symptoms onset and identification Call EMS Pre-hospital phase ER Increasing Loss of Myocytes

  5. Practical Limitations of Primary PCI as a Universal Reperfusion Strategy • Time delays (DBT, transfer time, waiting time for next available ambulance etc.) • Availability of invasive facilities • Operators’ skillness and cath lab volume load • Reorganization of EMS systems not conductive to making PPCI • EMS lacking 12-lead ECG capabilities • Not all patients having STEMI are transported by EMS • Mandates to transport patients to the nearest facility

  6. Transport in STEMI Networks: a ContinousOdissey Is it my ECG? No, It Is Your Route Organization of ambulance systems, prehospital management, and adequate PCI capacity appear now to be the key issues in providing reperfusion therapy for AMI.

  7. Clinical Impact of Direct Referral to PCI Following pre-H Diagnosis of STEMI PRAGUE-1 PRAGUE-2 MAASTRICT DANAMI-2 Terkelsen et al. Aashein et al. Symptom onset to balloon inflation (minutes) No prehospital diagnosis Admission to local hospital Subsequently transferred to interventional hospital Prehospital diagnosis Admission to local hospital Subsequently transferred to interventional hospital Prehospital diagnosis Local hospital bypassed. Patients rerouted directly to interventional hospital Terkeisen et al. J Electrocardiology 2005; 36: 187

  8. IsPossibletoApplyTheseFindings in a “Real World”Setting?

  9. Implementation of Guidelines Improve the Standard of Care The Vienna STEMI Registry REPERFUSION THERAPY MORTALITY 86.6% 16% 66% 9.5% % PRE POST PRE POST • EMS coordinated with 5 Heart Hospitals • Rotated 24 hr PCI availability • Evaluated frequency of PCI and Lytics • Evaluated Mortality Kalla K, et al. Circulation 2006;113:2398

  10. The Ottawa Hospital Institute STEMI RegionalProgram

  11. The Citywide Ottawa Program Time to Treatment Field transf Inter-hosp. transf p<0.001 p<0.001 ECG to Balloon Time Proportion of Patients (%) Interhospital transfers Field transfers % P<0.001 DTB<90 min DTB<120 min Minutes Le May RM et al. N Engl J Med 2008;358:231

  12. Establishing Infarct Networks Medical Response Delay Door to Balloon Time < 90 min 85.7% 51% 37.5% EMS12 Lead Pre-Arrival Activation EMS 12 Lead No EMS 12 Lead Prehosp Emerg Care 2006;10:374-377

  13. Comparison of Existing Prehospital ECG Programs

  14. # of Pts Treated Earlier with Prehospital Thrombolysis Data from the ER-TIMI-19 Trial 97% 49% 48% % Treated Pts Pre-H Thrombolysis In-H Thrombolysis 5% 0 20 40 80 100 120 140 60 Time from Ambulance Arrival (min) Morrow DA, et al. J Am Coll Cardiol. 2002;40:71

  15. Pre-hospital Thrombolysis:Meta-analysis of 6 RCT (n=6436) 14 12 10 Time to thrombolysis: 104 (7) min for pre-H 162 (16) min for in-H 8 % mortality: pre-hospital thrombolysis 6 4 2 OR 0.83 95% CI 0.70-0.98 0 0 4 6 8 10 12 14 2 % mortality: In-hospital thrombolysis Morrison LJ et al. JAMA 2000;283:2686

  16. Pre-hospitalThrombolysis asFacilitationtoPrimary PCI (p=0.003, Group B vs. C+DNT) % Pts with Angiographic Perfusion Score 10 (n=19) (n=18) (n=23) A B C Pre-H Thrombolysis Full Dose Pre-H Thrombolysis ½ Dose + Urgent PCI Primary PCI (not eligible to lysis or excluded) Smalling RW, et al. J Am Coll Cardiol. 2007;50:1612

  17. The TRANSFER AMI Trial ‘High Risk’ ST Elevation MI within 12 hours of symptom onset Community Hospital Emergency Department TNK + ASA + Heparin / Enoxaparin + Clopidogrel “Pharmacoinvasive Strategy” Urgent Transfer to PCI Centre “Standard Treatment” Assess chest pain, STresolution at 60-90 minutes after randomization Failed Reperfusion* Successful Reperfusion PCI Centre Cath Lab Cath / PCI within 6 hrs regardless of reperfusion status Cath and Rescue PCI  GP IIb/IIIa Inhibitor Elective Cath  PCI > 24 hrs later Repatriation of stable patients within 24 hrs of PCI * ST segment resolution < 50% & persistent chest pain, or hemodynamic instability Cantor WJ, et al. N Engl J Med 2009;360:2705

  18. Standard (n=496) Pharmacoinvasive (n=508) 30-Day Death, re-MI, CHF, Severe Recurrent Ischemia, Shock % of Patients 18 16.6 16 14 OR=0.537 (0.368, 0.783); p=0.0013 12 10.6 10 8 6 4 2 0 0 5 10 15 20 25 30 Days from Randomization n=496 n=508 422 468 415 466 415 463 414 461 414 460 412 457 Cantor WJ, et al. N Engl J Med 2009;360:2705

  19. TIMI 3 PatencyBefore Primary PCI in Randomised Trials on GP IIb/IIIa Inhibitors TIMI 3 Flow (%) Early Late or no GP IIb/IIIa blocker use 70 60 60 50 40 34 32 32 29 27 30 25 20 19 17 20 16 16 15 11 14 10 10 8 10 7 5 2 0 Zorman ERAMI ADMIRAL TIGER-PA INTAMI TNK TITAN Reo-Mobile ReoPro- Cutlip On-TIME bridging Tirofiban Integrilin Lysis Abciximab

  20. Ongoing Tirofiban In Myocardial Infarction Evaluation: ON-TIME 2 Trial Acute myocardial infarction diagnosed in ambulance or referral center ASA + 600 mg Clopidogrel + UFH N=984 6/2006-11/2007 Placebo Tirofiban * Transportation Angiogram Angiogram PCI center Tirofiban provisional PCI Tirofiban cont’d *Bolus: 25 µg/kg & 0.15 µg/kg/min infusion Van’t Hof AW, et al. Lancet. 2008;372:537

  21. Ongoing Tirofiban In Myocardial Infarction Evaluation: ON-TIME 2 Trial Cumulative ST- Deviation over Time [mm] 14.5±9.1 14.3±9.1 12.1±9.4 10.9±9.2 5.9±8.1 4.8±6.3 4.4±5.3 3.3±4.3 p=0.84 0.028 0.022 0.002 Van’t Hof AW, et al. Lancet. 2008;372:537

  22. Ongoing Tirofiban In Myocardial Infarction Evaluation: ON-TIME 2 Trial Residual ST-Deviation and Mortality % Van’t Hof AW, et al. Lancet. 2008;372:537

  23. The EUROTRANSFER Registry: Impact of Prehospital Abciximab on TIMI flow p<0.0001 p<0.001 Before PCI After PCI Dudek D, et al. Am Heart J 2008;156:1147

  24. Bivalirudin in Primary PCI. 1-Year Results of the HORIZONS-AMI 15 12 11.9% 11.9% 9.2% 10 8 5.8% 5 4 HR 1.00 (95% CI 0.82-1.21) p=0.98 HR 0.61 (95% CI 0.48-0.78) p=0.0001 0 0 0 6 12 0 6 12 Time (months) Time (months) 20 18.3% Bivalirudin (n=1800) 15.6% 15 Control (n=1802) 10 HR 0.83 (95% CI 0.71-0.97) p=0.022 5 0 0 6 12 Time (months) Mehran R, et al. Lancet 2009;374:1149

  25. Feasibility and Safety of Prehospital Administration of BivalirudinDuring STEMI * * * * % *: p<0.05 Sejersten, M, et al. Am J Cardiol 2009;103:1635

  26. Impact of Early ClopidogrelTx on In-H Mortality in STEMI: the ACOS-Registry Aspirin Aspirin + clopidogrel % 18 15.6 16 14 12.4 12 9.7 9.4 9.3 10 8 5.6 5.1 6 4.2 4 2 0 Total No reperfusion Lysis Primary PCI Zeymer U et al. Eur Heart J 2006;27:2661

  27. Clopidogrel LD in Pts Undergoing Primary PCI Results from the HORIZONS-AMI p=0,0007 p=0,0497 p=0,004 Bivalirudin 300 mg Loading Dose p=0,004 600 mg Loading Dose p=0,02 UnfractionedHeparin plus Glycoprotein IIb/IIIaInhibitors p=0,07 Dangas G, et al. J Am Coll Cardiol 2009;54:1438

  28. Clopidogrel: Double vs SD. STEMI PCI Cohort S. Mehta @ TCT 2009; September 24; San Francisco, CA

  29. Hospital until discharge or day 7 Pre-hospital Clopidogrel Administered Pre-h to Improve Primary PCI: the CIPAMI Study n = 327 Clopidogrel 600 mg Treatment according to investigator n = 654 with STEMI Acute STEMI <6h Angina >20 min ST elevation >2 leads or new/presumed LBBB (Secondary endpoints) Death, Re-MI, TVR Primary angiography Primary endpoint PCI R Aspirin +UFH/enoxaparin n = 327 No loading Clopidogrel loading prior to PCI strongly recommended Zeymer U et al. Cardiology 2007;108:265

  30. Pre-hospital Three Different LD of Clopidogrel Administered at FMC in AMI. The LOAD & GO Trial Clopidogrel 600 mg n = 150 with STEMI Acute STEMI <12h Angina >30 min ST elevation >0.2 mV in >2 leads or new/presumed LBBB Clopidogrel 300 mg None (Primary endpoints) TMPG PCI R Aspirin +UFH/enoxaparin Clopidogrel 900 mg P.I.s: Leonardo Bolognese and Kenneth Ducci Ospedale S. Donato, Arezzo

  31. Prasugrel in Primary PCI. A Subanalysis of TRITON-TIMI 38 CV death/non-fatal MI/urgent TVR CV death/non-fatal MI/non-fatal stroke Clopidogrel 15 Prasugrel 10 5 p=0.0017 p=0.0221 p=0.0205 p=0.0250 0 0 200 450 0 200 450 Stent Thrombosis TIMI major bleeding (no CABG) 15 10 p=0.0084 5 p=0.0232 p=0.3359 p=0.6451 0 0 200 450 0 200 450 Days after Randomization Days after Randomization Montalescot G, et al. Lancet 2009;373:723

  32. PLATO Randomized Trial. STEMI Cohort @ AHA 2009; November 14-18 2009; Orlando, FL

  33. The Tension Between Needing to Improve Care and Knowing How to Do it! • The need to shorten delays andto improve the quality of care for STEMI pts is urgent. We cannot wait! It’s up to us!! • Prehospital management is a key issue in 2010! • Emulating successful organizations can speed effective improvement. • A combined strategy of immediate thrombolysis or potent antithrombotic agents in the ambulance followed by PCI could theoretically provide early, complete and successful myocardial reperfusion.

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