Management dell’Infarto Miocardico Acuto a presentazione “sopralivellamento del tratto ST”...
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Management dell’Infarto Miocardico Acuto a presentazione
“sopralivellamento del tratto ST”
STEMI
Linee Guida ESC 2012
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Time to Reperfusion and OutcomeTime to Reperfusion and Outcome
0
20
40
60
80
100
1 3 6 12 12-24
%%
Extent of salvage (% of area at risk)
Mortality reduction (%)
D
A-B – no benefit
Potential outcomes
A-C – benefitD-C – harm
C
B A
B-C – benefit ?
Gersh JAMA 2005
Time to treatment is critical
Opening the IRA PPCI>lysis
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13Tcheng J Am Coll Cardiol 48:1336, 2006
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Systemdelay
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Protocollo condiviso
Monitoraggio continuo
Direttamente in sala emodinamica
Bypass DEA
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FMCDiagnosi
Ecg teletrasmesso
Cardiologo UTIC
Emodinamista reperibile& staff : infermiere/TRS
1 accesso diretto sala Accesso diretto sala per 1PTCA
Percorso+ attivazione sala
Trasporto monitoraggio
Ritardo di sistema
Percoso STEMI pistoia
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STEMI ENTRO 12 ORE ANNO 2012STEMI ENTRO 12 ORE ANNO 2012N.TOTALEPAZIENTI 0
0173
POST-TL
RESCUE
PCI PRIMARIA
6437%
2615%
8348%
DIRETTAAL CL
TRASFERITADA SPOKE
AMMESSAAD HUB
173
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0
50
100
150
200
250
300
350
0 20 40 60 80 100 120 140 160 180 200
N. PAZIENTI 173 – MEDIANA D2B: 90 MINUTIN. PAZIENTI 173 – MEDIANA D2B: 90 MINUTI
D2B TOTALE PAZIENTI N. 173D2B TOTALE PAZIENTI N. 173M
INU
TI
PAZIENTI
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N. PAZIENTI 64 – MEDIANA D2B: 84 MINUTIN. PAZIENTI 64 – MEDIANA D2B: 84 MINUTI
D2B AMMISSIONE DIRETTA 118D2B AMMISSIONE DIRETTA 118
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N. PAZIENTI 47 – MEDIANA D2B: 90 MINUTIN. PAZIENTI 47 – MEDIANA D2B: 90 MINUTID2B AMMISSIONE PS PO PISTOIAD2B AMMISSIONE PS PO PISTOIA
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N. PAZIENTI 45 – MEDIANA D2B: 100 MINUTIN. PAZIENTI 45 – MEDIANA D2B: 100 MINUTID2B AMMISSIONE PS PO PESCIAD2B AMMISSIONE PS PO PESCIA
MIN
UTI
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0
50
100
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350
0 5 10 15 20 25 30
N. PAZIENTI 26 – MEDIANA D2B: 125 MINUTIN. PAZIENTI 26 – MEDIANA D2B: 125 MINUTIPCI di trasferimento tra POPCI di trasferimento tra PO
MIN
UTI
PAZIENTI
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36
Motality benefit of primary PCI declines with Motality benefit of primary PCI declines with “PCI-related time delay”“PCI-related time delay”
Favors PCI
Favors fibrinolysis with a fibrin-specific agent
13 RCTsN = 5494 P = 0.04
Abs
olut
e R
isk
Diff
eren
ce in
Dea
th (%
)
30 40 50 60 70 80
PCI-Related Time Delay (minutes)
10 −
5 −
0 −
-5 − ┬ ┬ ┬ ┬ ┬ ┬
Nallamothu and Bates. Am J Cardiol 2003;92:824.
Mortality equipose:60 min
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F. Van de Werf, ACC 2013
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F. Van de Werf, ACC 2013
• 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
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F. Van de Werf, ACC 2013
A strategy of early fibrinolysis followed 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
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F. Van de Werf, ACC 2013
no lytic
STUDY PROTOCOL
RANDOMIZATION 1:1 by IVRS, OPEN LABEL
Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30
ECG at 90 min: ST resolution ≥ 50%
Standard primary PCI
Aspirin Clopidogrel:
LD 300 mg + 75 mg QDEnoxaparin:
30 mg IV + 1 mg/kg SC Q12h
Antiplatelet andantithrombin treatment
according to local standards
angio >6 to 24 hrsPCI/CABG if indicated
immediate angio + rescue PCI if
indicated
YES
NO
Strategy A: pharmaco-invasive Strategy B: primary PCI
AspirinClopidogrel:
75 mg QDEnoxaparin:
0.75 mg/kg SC Q12h
STEMI <3 hrs from onset symptoms, PPCI <60 min not possible, 2 mm ST-elevation in 2 leads
≥75y: ½ dose TNK<75y:full dose After 20% of the planned recruitment, the TNK dose was reduced by
50% among patients ≥75 years of age.
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F. Van de Werf, ACC 2013
62
Sx onset1st Medical
contact
611 Hour 2 Hoursn=1892
29
Randomize IVRS
9
Rx TNK
31 86
Sx onsetRx PPCI
100 min
178 min
MEDIAN TIMES TO TREATMENT (min)
1st Medical contact
78 min differenceRandomize IVRS
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F. Van de Werf, ACC 2013
62
Sx onset
611 Hour 2 Hours
29 9
Rx TNK
31 86
Sx onsetRx PPCI
100 min
178 min
MEDIAN TIMES TO TREATMENT (min)
36% Rescue PCI at 2.2h
n=1892
64% non-urgent cath at 17h
1st Medical contact
Randomize IVRS
1st Medical contact Randomize IVRS
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F. Van de Werf, ACC 2013
PRIMARY ENDPOINT
TNK 12.4%PPCI 14.3%
TNK vs PPCIRelative Risk 0.86, 95%CI (0.68-1.09)
p=0.24
Dth/
Shoc
k/CH
F/Re
MI (
%)
The 95% CI of the observed incidence in the pharmaco-invasive arm would exclude a 9% relative excess compared with PPCI
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F. Van de Werf, ACC 2013
STROKE RATES
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Bleeding Risk SubgroupsBleeding Risk SubgroupsTherapeutic ConsiderationsTherapeutic Considerations
Significant Net Clinical Benefit
with Prasugrel80%
MD MD 10 mg10 mg
Reduced MD
Guided by PK
Age > 75 or
Wt < 60 kg16%
Avoid
Prasugrel
Prior
CVA/TIA4%4%
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0
2
4
6
8
0 1 2 3
1
0 3060 90 180 270 360 450
HR 0.82P=0.01
HR 0.80P=0.003
5.6
4.7
6.9
5.6
Days
Prim
ary
Endp
oint
(%)
Prasugrel
Clopidogrel
Prasugrel
Clopidogrel
Loading Dose Maintenance Dose
Timing of BenefitTiming of Benefit(Landmark Analysis)(Landmark Analysis)
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Time-related Kaplan–Meier estimates of the time to first occurrence of the primary end point (incidence of MI, stroke, or vascular death; HR, 0.87; 95% CI, 0.75 to 1.01; P=0.07)
PLATO - STEMI substudy - Outcomes
Steg P.G., et al. Circulation 2010;122:2131-2141
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