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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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Presentation on theme: "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."— Presentation transcript:

1 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 Conflict of interest: none Convegno Area Emergenza-Urgenza ANMCO Preparazione alla PTCA nelle Sindromi Coronariche Acute Roma, 20 Marzo 2010

2 Symptoms onset and identification Call EMS ER Cath Lab Pre-hospital phase Increasing Loss of Myocytes Factors Associated with Delays in Mechanical Reperfusion Tx

3 Symptoms onset and identification Call EMS ER Cath Lab Pre-hospital phase Factors Associated with Delays in Mechanical Reperfusion Tx Increasing Loss of Myocytes

4 Symptoms onset and identification Call EMS ER Cath Lab Pre-hospital phase Factors Associated with Delays in Mechanical Reperfusion Tx 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 Continous Odissey 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 Terkeisen et al. J Electrocardiology 2005; 36: 187 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 PRAGUE-1 PRAGUE-2 MAASTRICT DANAMI-2 Terkelsen et al. Aashein et al. Clinical Impact of Direct Referral to PCI Following pre-H Diagnosis of STEMI

8 Is Possible to Apply These Findings in a Real World Setting?

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

10 The Ottawa Hospital Institute STEMI Regional Program

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

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

13 Comparison of Existing Prehospital ECG Programs LocationPrehospital ECG Interpretation Activate Catheterization Lab en Route to Hospital Bypass Non-PCI Hospitals Boston Am J Emerg Med. 2005;23:443 Paramedic interpretationYes (activation by emergency department physician based on paramedic interpretation) Yes (for all patients with definite STEMI or possible STEMI) Los Angeles County Am Heart J. 2006;152:661 Computer algorithm interpretation Yes (activation by emergency department physician based on computer algorithm interpretation) Yes (for all patients with acute MI) North Carolina JAMA. 2007;298:2371 Mixed (used computer algorithm interpretation, paramedic interpretation, or wireless transmission) Mixed (activation by paramedics or emergency department physician) Mixed (paramedics occasionaly diverted patients with STEMI to nearest PCI hospital) Ottawa N Engl J Med. 2008;358:231 Paramedic interpretationMixed (activation by paramedic through a central page operator) Yes (for all patients with STEMI)

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

15 (n=19)(n=18)(n=23) (p=0.003, Group B vs. C+DNT) % Pts with Angiographic Perfusion Score 10 A BC 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 Pre-hospital Thrombolysis as Facilitation to Primary PCI

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

17 Days from Randomization % of Patients Standard (n=496) Pharmacoinvasive (n=508) n=496 n= Day Death, re-MI, CHF, Severe Recurrent Ischemia, Shock OR=0.537 (0.368, 0.783); p= Cantor WJ, et al. N Engl J Med 2009;360:2705

18 TIMI 3 Patency Before Primary PCI in Randomized Trials on GP IIb/IIIa Inhibitors TIMI 3 Flow (%) Abciximab TirofibanIntegrilin Lysis Zorman Reo- Mobile ERAMI ReoPro- bridging ADMIRAL Cutlip TIGER-PA On- TIME INTAMITNK EarlyLate or no GP IIb/IIIa blocker use TITAN

19 Acute myocardial infarction diagnosed in ambulance or referral center ASA mg Clopidogrel + UFH Angiogram Tirofiban * Placebo Transportation PCI center Angiogram Tirofibanprovisional Tirofibancontd N=984 6/ /2007 PCI *Bolus: 25 µg/kg & 0.15 µg/kg/min infusion Ongoing Tirofiban In Myocardial Infarction Evaluation: ON-TIME 2 Trial Vant Hof AW, et al. Lancet. 2008;372:537

20 Cumulative ST- Deviation over Time 14.3± ± ± ± ± ± ± ± p=0.84 [mm] Ongoing Tirofiban In Myocardial Infarction Evaluation: ON-TIME 2 Trial Vant Hof AW, et al. Lancet. 2008;372:537

21 Ongoing Tirofiban In Myocardial Infarction Evaluation: ON-TIME 2 Trial Residual ST-Deviation and Mortality % Vant Hof AW, et al. Lancet. 2008;372:537

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

23 Mehran R, et al. Lancet 2009;374:1149 Bivalirudin in Primary PCI. 1-Year Results of the HORIZONS-AMI 18.3% 15.6% HR 0.83 (95% CI ) p= Bivalirudin (n=1800) Control (n=1802) HR 0.61 (95% CI ) p= % 5.8% HR 1.00 (95% CI ) p= % Time (months)

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

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

26 Clopidogrel: Double vs SD. STEMI PCI Cohort S. TCT 2009; September 24; San Francisco, CA OutcomeStandard clopidogrel (n=3175) Double-dose clopidogrel (n=3171) Hazard ratio (95% CI) Definite stent thrombosis (0.35–0.84) All stent thrombosis (0.54–0.96) MI (0.41–0.94) MI or stent thrombosis (0.54–0.92) CURRENT major (0.75–1.78) CURRENT severe (0.72–1.93)

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

28 Pre-hospital PCI (Primary endpoints) TMPG R 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 P.I.s: Leonardo Bolognese and Kenneth Ducci Ospedale S. Donato, Arezzo Three Different LD of Clopidogrel Administered at FMC in AMI. The LOAD & GO Trial Clopidogrel 900 mg None Clopidogrel 300 mg Aspirin + UFH/enoxaparin

29 Prasugrel in Primary PCI. Data from TRITON-TIMI 38 Montalescot G, et al. Lancet 2009;373:723 p= p=0.0232p=0.3359p= p=0.0017p= p=0.0205p= Prasugrel Clopidogrel Days after Randomization CV death/non-fatal MI/non-fatal stroke CV death/non-fatal MI/urgent TVR Stent ThrombosisTIMI major bleeding (no CABG)

30 PLATO Randomized Trial. STEMI AHA 2009; November ; Orlando, FL End pointTicagrelor (180 mg+90 mg BID) Clopidogrel (300 mg+75 mg daily) Hazard ratio for ticagrelor p Primary end point: death from vascular causes, MI, or stroke All-cause mortality CV mortality Definite stent thrombosis MI Primary safety event: major bleeding

31 The need to shorten delays and to improve the quality of care for STEMI pts is urgent. We cannot wait! Its 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. The Tension Between Needing to Improve Care and Knowing How to Do it!

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