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Francesco Chiarella Ospedale S.Corona Pietra Ligure STEMI PREPARAZIONE ALLA ANGIOPLASTICA NEGLI OSPEDALI SENZA EMODINAMICA La preparazione alla PTCA nelle.

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Presentazione sul tema: "Francesco Chiarella Ospedale S.Corona Pietra Ligure STEMI PREPARAZIONE ALLA ANGIOPLASTICA NEGLI OSPEDALI SENZA EMODINAMICA La preparazione alla PTCA nelle."— Transcript della presentazione:

1 Francesco Chiarella Ospedale S.Corona Pietra Ligure STEMI PREPARAZIONE ALLA ANGIOPLASTICA NEGLI OSPEDALI SENZA EMODINAMICA La preparazione alla PTCA nelle SCA PREPARAZIONE FARMACOLOGICA ALLA PTCA: DALLE LINEE GUIDA AI DATI DEGLI STUDI E DEI REGISTRI PAF 2010

2 CENSIMENTO UTIC / ab. 1 letto UTIC / ab. 5° Censimento Federativo Strutture Cardiologiche

3 HUB 177 BLITZ-3: provenienza ricoveri UTIC

4 PREPARAZIONE FARMACOLOGICA A PTCA OSPEDALI SENZA EMODINAMICA: DALLE LINEE GUIDA AI DATI DEGLI STUDI E DEI REGISTRI Linee Guida: rielaborazioni annuali su STEMI e PCI da Comitati Congiunti di 5 Società Scientifiche

5 IMPRESCINDIBILITA DI PROTOCOLLI CONDIVISI UPDATE 2009 Ogni comunità deve sviluppare un protocollo (sistema di cure) per lo STEMI Team multidisciplinare Sistema Emergenza Territoriale Ospedale/i no Cath-Lab (Spoke) Ospedale/i con Cath Lab (Hub) ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update

6 A ciascun Pz il suo percorso A ciascun Pz il suo trattamento QUALE FARMACO? ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update

7 Pathway: Triage and Transfer for PCI (in STEMI) 2009 STEMI Focused Update. Appendix 5 STEMI patient who is a candidate for reperfusion Initially seen at a PCI capable facility Initially seen at a non-PCI capable facility Send to Cath Lab for primary PCI (Class I, LOE:A) Transfer for primary PCI (Class I, LOE:A) Initial Treatment with fibrinolytic therapy (Class 1, LOE:A) Prep antithrombotic (anticoagulant plus antiplatelet) regimen Diagnostic angio Medical therapy only PCICABG NOT HIGH RISK Transfer to a PCI facility may be considered (Class IIb, LOE:C), especially if ischemic symptoms persist and failure to reperfuse is suspected HIGH RISK Transfer to a PCI facility is reasonable for early diagnostic angio & possible PCI or CABG (Class IIa, LOE:B), High-risk patients as defined by 2007 STEMI Focused Update should undergo cath (Class 1: LOE B) Tempo da angor > 3 h Tempo al pallone < 1 h Alto score di rischio / rischio emorragico Tempo da angor 1 h Basso score rischio / no rischio emorr.

8 A tutti prima possibile: Update La dose di carico di tienopididine è raccomandata per tutti STEMI Clopidogrel almeno 300 – 600 mg appena possibile a tutti i pazienti avviati a PCI primaria o non primaria. ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update Studi di dose finding hanno dimostrato che aumentando il dosaggio si inibiscono PTL più rapidamente, , ma la sicurezza e lefficacia clinica non sono ancora rigorosamente stabilite,

9 Limitazioni: età > 75 storia di TIA o stroke, active bleeding urgente BPAC anticoagulanti peso < 60 Kg STEMI PCI primaria Prasugrel 60 mg should be given as soon as possible for primary PCI. MODIFIED Recommendation STEMI: PREPARAZIONE ALLA ANGIOPLASTICA NEGLI OSPEDALI SENZA EMODINAMICA entra PRASUGREL

10 10 TRITON-TIMI 38 Double-blind ACS (STEMI or UA/NSTEMI) & Planned PCI ASA PRASUGREL 60 mg LD/ 10 mg MD CLOPIDOGREL 300 mg LD/ 75 mg MD 1 o endpoint: CV death, MI, Stroke 2 o endpoints:CV death, MI, Stroke, Rehosp-Rec Isch CV death, MI, UTVR Stent Thrombosis (ARC definite/prob.) Safety endpoints: TIMI major bleeds, Life-threatening bleeds Key Substudies:Pharmacokinetic, Genomic Median duration of therapy - 12 months N= 13,600 Wiviott SD et al AHJ 152: 627,2006 Adapted with permission from E.Antman

11 HR 0.81 ( ) P= Prasugrel Clopidogrel Days Endpoint (%) HR 1.32 ( ) P=0.03 Prasugrel Clopidogrel events 35 events Balance of Efficacy and Safety CV Death / MI / Stroke TIMI Major NonCABG Bleeds NNT = 46 NNH = 167 Adapted with permission from Wiviott SD et al NEJM 357:2007 TRITON: Results The number of subjects who would need to be treated to result in one excess major bleed (NNH) was 167 Trattare 46 x prevenire un evento Trattare 167 x causare un bleeding

12 Percent (%) Days From Randomization 9.5% 6.5% HR 0.68 ( ) P= % 10.0% HR 0.79 ( ) P=0.02 Clopidogrel Prasugrel NNT = 42 CV Death / MI / Stroke TIMI Major NonCABG Bleeds Clopidogrel Prasugrel STEMI Cohort N=3534 Montalescot et al Lancet 2008.Adapted with permission from Antman EM. TRITON TIMI-38

13 HR 0.82 P=0.01 HR 0.80 P= Days Primary Endpoint (%) Prasugrel Clopidogrel Prasugrel Clopidogrel Loading DoseMaintenance Dose Timing of Benefit (Landmark Analysis - 3 days) Adapted with permission from Antman EM JACC TRITON TIMI-38

14 For STEMI undergoing non-primary PCI carico prasugrel dopo coronarografia pre-PTCA ( entro 1 h) 14 the following regimens are recommended: If the patient did not receive fibrinolytic therapy… either c.…either a loading dose of mg of clopidogrel should be given or, once the coronary anatomy is known and PCI is planned, a loading dose of 60 mg of prasugrel should be given promptly and no later than 1 hour after the PCI. MODIFIED Rec ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update

15 Ticagrelor ! PLATO: STEMI e NSTEMI random ticagrelor vs clopidogrel ( 180-mg loading dose, 90 mg twice daily thereafter ) ( 300-to-600-mg loading dose, 75 mg daily thereafter ). NEJM, 361: antagonist of recettore adenosinico P2Y12

16 PCI facilitata e rescue: termini obsoleti (molto attuali) I termini facilitated PCI e rescue PCI non dovrebbero più essere usati Contemporary therapeutic choices leading to reperfusion for pts with STEMI can be described without these potentially misleading labels Cambio concettuale: la riperfusione è lobiettivo, non si parlerà più di facilitazione e di rescue, termini giudicati confondenti e obsoleti che siamo invitati a mandare in cantina ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update

17 CARESS Transfer-AMI FINESSE per testare fibrinolisi+PCI subito vs fibrinolisi + PCI rescue Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in nAMI (TRANSFER-AMI) Combined Abciximab REteplase Stent Study in AMI per testare ½ fibrinolisi + ABCX + PCI > > STEMI alto rischio

18 CARESS-IN-AMI: DISEGNATO ALLA RICERCA DEL MIGLIORE TRATTAMENTO PER I PZ CON STEMI NEGLI OSPEDALI NO CATH-LAB 600 STEMI –<75 years old –> 1 high risk feature –RETEPLASE ½ dose, ABCX, heparin, ASA Randomizzazaione a trasferimento immediato x pci o trasferimento x rescue o differito Not a trial of facilitated angioplasty opposed to primary angioplasty

19 CARESS-IN-AMI: Primary Outcome STEMI con immediata PCI: minor numero di eventi avversi a 30 gg Non differenze significative di sanguinamenti 10.7% 4.4% Di Mario et al. Lancet 2008;371. CARESS: legittima reteplase metà dose, ABCX, eparina, ASA e poi trasferire RETEPLASE ½ dose, ABCX, heparin, ASA

20 TRANSFER-AMI Studio di strategia farmacoinvasiva in 1059 STEMI alto rischio giunti entro 12 ore da esordio ad ospedale senza cathlab A tutti: - TNK standard-dose, ASA, UFH or enoxaparin - Clopidogrel loading 300 mg for pts < 75 age 75 mg for pts >75 age Giunti nel Centro con CathLab: -GP IIb/IIIa receptor antagonists according to institutions standard practice Cantor et al. N Eng J Med 2009;360:26. DISEGNO: TNK STANDARD E PCI ENTRO 24 H VERSUS TTNK STANDARD E PCI DIFFERITA > 24 H 2.8 hrs 32 hrs PCI RISULTERA

21 TRANSFER-AMI: efficacia e sicurezza 17 % 11 % RR= 0.64, 95 CI% ( ) Cumulative Incidence Days p=0.004 Cantor et al. N Engl J Med 2009;360:26 pharmaco-invasive EARLY PCI Severe bleeding (GUSTO criteria) : no differenze tra i due gruppi Mild bleeding (GUSTO criteria) : higher incidence in the pharmaco-invasive group ( 13.0% vs 9.%, p=0.036 ). Kaplan Meier Curves for Primary Endpoint TRANSFER AMI legittima TNK dose standard, ASA, clopidogrel, eparina poi trasferire

22 TRANSFER-AMI: CONCLUSIONI In STEMI ad alto rischio che si presentano a Ospedale Spoke: - fibrinolisi con TNK dose standard, clopidogrel - trasferimento a Hub per eseguire subito angiografia e PCI without waiting to determine whether reperfusion has occurred. Cantor et al. N Eng J M 2009;360:26.

23 23 Recommendations for the Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMI

24 E RAGIONEVOLE INIZIARE IL TRATTAMENTO CON ANTI IIb/IIIa AL MOMENTO DI ANGIOPLASTICA (CON O SENZA STENTING) abciximab tirofiban, eptifibatide Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMI Modified Recommendation

25 Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMI LUTILITA DI ANTI IIb/IIIa COME STRATEGIA FARMACOLOGICA DI PREPARAZIONE ALLA ANGIOPLASTICA prior to arrival in the cardiac catheterization laboratory for angiography and PCI is uncertain. Modified Recommendation

26 I risultati del FINESSE pubblicati dopo le Linee Guida riaccendono la disputa pre-PCI ½ -dose lytic + ABCX pre-PCI ABCX alone ABCX at time of PCI

27 FINESSE: Study design Ellis et al. N Eng J Med. 2008;358: Treatment Pre-PCI treatment with ½ -dose lytic plus abciximab, pre-PCI abciximab alone, and abciximab at time of PCI Inclusion Suspected acute MI (ST change or LBBB) within 6 h of symptom onset Exclusion Low risk (<60 yo, localized inferior infarct) high risk for bleeding 1° OUTCOMES Death, VF after 48 hours, shock, CHF within 90 days

28 Considerando solo alto rischio, tempo < 4 ore N = 2452 N = 397 Meno morti a 1 anno !

29 29 Recommendations for Use of Parenteral Anticoagulants in Patients with STEMI

30 Use of Parenteral Anticoagulants in STEMI Modified Recommendation a.UN BOLO AGGIUNTIVO DI EPARINA NON FRAZIONATA PER I PZ CHE GIA LA ASSUMEVANO per mantenere un adeguato regime di scoagulazione (misurare ACT) IL TRATTAMENTO ANTICOAGULANTE RACCOMANDATO NEGLI STEMI PTCA PRIMARIA INCLUDE : b. BIVALIRUDINA, CON O SENZA PRECEDENTE EPARINA Enoxaparin and fondaparinux unchanged from 2007 STEMI Focused Update

31 31 HORIZONS-AMI: Design Stone et al. N Eng J Med. 2008;358: patients with STEMI & symptom onset 12 hours randomized 1800 received bivalirudin alone * Principal management strategy Primary PCI, 1678 (93.2%) Deferred PCI, 5 (0.3%) CABG, 23 (1.3%) Medical management, 94 (5.2%) 1802 received heparin + GP IIb/IIIa inhibitor Principal Management Strategy Primary PCI, 1662 (92.2%) Deferred PCI, 3 (0.2%) CABG, 40 (2.2%) Medical Management, 97 (5.4%) Emergency angiography Endpoints : Composite of net adverse clinical events (NACE) Included major bleeding plus MACE (a composite of CVD death, reinfarction, target- vessel revascularization for ischemia, and stroke within 30 days)

32 HORIZONS-AMI: Time-to-Event Curves through 30 days: Net Adverse Clinical Events Meno eventi avversi a 30 gg con bivalirudina da sola piuttosto che con eparina non frazionata + anti IIb/IIIa Stone et al. N Eng J Med. 2008;358: HR=0.75, ( ); p=0.006] QS STUDIO MOTIVA INDICAZIONE CLASSE I 3602 patients with STEMI & symptom onset 12 hours randomized

33 HORIZONS-AMI: Time-to-Event Curves through 30 days: Major Bleeding HR=0.59 ( ) p< Stone et al. N Eng J Med. 2008;358: Meno sanguinamenti a 30 gg con bivalirudina da sola piuttosto che con eparina non frazionata + anti IIb/IIIa

34 HORIZONS-AMI: Results (cont.) Treatment with bivalirudin compared with UFH plus GP IIb/IIa inhibitors resulted in significantly lower: –30-day death rates from cardiac causes (1.8% vs. 2.9%; RR 0.62; 95% CI 0.40 to 0.95; p=.03), & –30-day death from all causes (2.1% vs. 3.1%; RR 0.66; 95% CI 0.44 to 1.00; p=0.047) At one year, MACE rates were identical, but there was a decrease in all-cause mortality with bivalirudin (3.4% versus 4.8%, p=0.03).

35 Use of Parenteral Anticoagulants in STEMI Modified Recommendation IL TRATTAMENTO ANTICOAGULANTE RACCOMANDATO NEGLI STEMI PTCA PRIMARIA INCLUDE: b. BIVALIRUDINA Enoxaparin and fondaparinux unchanged from 2007 STEMI Focused Update

36 Unfractionated heparin (UFH) administration guided by : –Therapeutic activated clotting time (ACT) levels –Prior administration of GP IIb/IIIa receptor antagonists Enoxaparin and fondaparinux unchanged from 2007 Enoxaparin, if the last subcutaneous dose was administered at least 8 to 12 hours earlier, an IV (intravenous) dose of 0.3 mg/kg of enoxaparin should be given; if the last subcutaneous dose was administered within the prior 8 hours, no additional enoxaparin should be given. (Level of Evidence: B) Fondaparinux, administer additional intravenous treatment with an anticoagulant possessing anti-IIa activity, taking into account whether GP IIb/IIIa receptor antagonists have been administered. (Level of Evidence: C)

37 STEMI PREPARAZIONE ALLA ANGIOPLASTICA NEGLI OSPEDALI SENZA EMODINAMICA TIENOPIRIDINE (Clopid. 300, Pras 60) TNK + EPARINA + IIbIIIa in sala RETEPLASE ½ + ABCX RETEPLASE ½ + ABCX o solo ABCX o ABCX in cathLab BIVALIRUDINA TRITRON TIMI 38 TRANSFER-AMI CARESS FINESSE HORIZONS AMI


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