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Management dell’Infarto Miocardico Acuto a presentazione “sopralivellamento del tratto ST” STEMI Linee Guida ESC 2012. 100. Mortality reduction (%). Potential outcomes. D. 80. A-B – no benefit. 60. C. %. 40. B. A. 20. Extent of salvage (% of area at risk). 0. 1. 3. 6. 12.
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Management dell’Infarto Miocardico Acuto a presentazione “sopralivellamento del tratto ST” STEMI Linee Guida ESC 2012
100 Mortality reduction (%) Potential outcomes D 80 A-B – no benefit 60 C % 40 B A 20 Extent of salvage (% of area at risk) 0 1 3 6 12 12-24 Time to Reperfusion and Outcome B-C – benefit ? A-C – benefit D-C – harm Time to treatment is critical Opening the IRA PPCI>lysis Gersh JAMA 2005
System delay
Patient Delay
Protocollo condiviso Monitoraggio continuo Direttamente in sala emodinamica Bypass DEA
Percoso STEMI pistoia Cardiologo UTIC 1 accesso diretto sala FMC Diagnosi Ecg teletrasmesso Accesso diretto sala per 1PTCA Trasporto monitoraggio Percorso+ attivazione sala Emodinamista reperibile & staff : infermiere/TRS Ritardo di sistema
STEMI ENTRO 12 ORE ANNO 2012 N.TOTALE PAZIENTI 173 0 RESCUE 0 POST-TL 173 PCI PRIMARIA 64 37% 26 15% 83 48% AMMESSA AD HUB DIRETTA AL CL TRASFERITA DA SPOKE
D2B TOTALE PAZIENTI N. 173 N. PAZIENTI 173 – MEDIANA D2B: 90 MINUTI MINUTI PAZIENTI
D2B AMMISSIONE DIRETTA 118 N. PAZIENTI 64 – MEDIANA D2B: 84 MINUTI
D2B AMMISSIONE PS PO PISTOIA N. PAZIENTI 47 – MEDIANA D2B: 90 MINUTI
D2B AMMISSIONE PS PO PESCIA N. PAZIENTI 45 – MEDIANA D2B: 100 MINUTI MINUTI
PCI di trasferimento tra PO N. PAZIENTI 26 – MEDIANA D2B: 125 MINUTI MINUTI PAZIENTI
Motality benefit of primary PCI declines with “PCI-related time delay” 10 − 13 RCTs N = 5494 P = 0.04 5 − Favors PCI Mortality equipose: 60 min Absolute Risk Difference in Death (%) 0 − Favors fibrinolysis with a fibrin-specific agent -5 − ┬ ┬ ┬ ┬ ┬ ┬ • 40 50 60 70 80 PCI-Related Time Delay (minutes) Nallamothu and Bates. Am J Cardiol 2003;92:824.
Large contemporary international registries continue to demonstrate persisting delays to primary PCI in STEMI patients first presenting to EMS or non-cath capable hospitals Subsequent transfer for primary PCI commonly results in reperfusion times exceeding current guideline recommendations These delays are associated with commensurate increases in morbidity and mortality BACKGROUND
A strategy of early fibrinolysisfollowed by coronary angiography within 6-24 hours or rescue PCI if needed was compared with standard primary PCI in STEMI patients with at least 2 mm ST-elevation in 2 contiguous leads presenting within 3 hours of symptom onset and unable to undergo primary PCI within 1 hour. STUDY AIM
STUDY PROTOCOL STEMI <3 hrs from onset symptoms, PPCI <60 min not possible, 2 mm ST-elevation in 2 leads RANDOMIZATION 1:1 by IVRS, OPEN LABEL Strategy B: primary PCI Strategy A: pharmaco-invasive After 20% of the planned recruitment, the TNK dose was reduced by 50% among patients ≥75 years of age. <75y:full dose no lytic ≥75y: ½ dose TNK Ambulance/ER Aspirin Clopidogrel: LD 300 mg + 75 mg QD Enoxaparin: 30 mg IV + 1 mg/kg SC Q12h Aspirin Clopidogrel: 75 mg QD Enoxaparin: 0.75 mg/kg SC Q12h Antiplatelet and antithrombin treatment according to local standards ECG at 90 min: ST resolution ≥ 50% PCI Hospital NO YES Standard primary PCI angio >6 to 24 hrs PCI/CABG if indicated immediate angio + rescue PCI if indicated Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30
MEDIAN TIMES TO TREATMENT (min) 1st Medical contact Randomize IVRS Sxonset Rx TNK 100 min 62 29 9 78 min difference 1st Medical contact Sxonset Randomize IVRS Rx PPCI 61 31 86 1 Hour 2 Hours 178 min n=1892
MEDIAN TIMES TO TREATMENT (min) 1st Medical contact Randomize IVRS Sxonset Rx TNK 36% Rescue PCI at 2.2h 100 min 62 29 9 64% non-urgent cath at 17h 1st Medical contact Sxonset Randomize IVRS Rx PPCI 61 31 86 178 min 1 Hour 2 Hours n=1892
PRIMARY ENDPOINT TNK vs PPCI Relative Risk 0.86, 95%CI (0.68-1.09) PPCI 14.3% TNK 12.4% p=0.24 Dth/Shock/CHF/ReMI (%) The 95% CI of the observed incidence in the pharmaco-invasive arm would exclude a 9% relative excess compared with PPCI
Bleeding Risk SubgroupsTherapeutic Considerations Reduced MDGuided by PKAge > 75 or Wt < 60 kg Avoid PrasugrelPrior CVA/TIA 16% 4% Significant Net Clinical Benefit with Prasugrel80% MD 10 mg
Timing of Benefit(Landmark Analysis) 8 6.9 Clopidogrel Clopidogrel 5.6 5.6 6 Primary Endpoint (%) 4.7 4 Prasugrel Prasugrel HR 0.82P=0.01 HR 0.80P=0.003 2 1 0 0 1 2 3 0 30 60 90 180 270 360 450 Days Loading Dose Maintenance Dose