Management dell’Infarto Miocardico Acuto a presentazione

“sopralivellamento del tratto ST”

STEMI

Linee Guida ESC 2012

Time to Reperfusion and OutcomeTime to Reperfusion and OutcomeTime 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

13Tcheng J Am Coll Cardiol 48:1336, 2006

Systemdelay

www.escardio.org/guidelines

PatientDelay

Protocollo condiviso

Monitoraggio continuo

Direttamente in sala emodinamica

Bypass DEA

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

STEMI ENTRO 12 ORE ANNO 2012STEMI ENTRO 12 ORE ANNO 2012

N.TOTALEPAZIENTI 0

0173

POST-TL

RESCUE

PCI PRIMARIA

6437%

2615%

8348%

DIRETTAAL CL

TRASFERITADA SPOKE

AMMESSAAD HUB

173

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

N. PAZIENTI 64 – MEDIANA D2B: 84 MINUTIN. PAZIENTI 64 – MEDIANA D2B: 84 MINUTI

D2B AMMISSIONE DIRETTA 118D2B AMMISSIONE DIRETTA 118

N. PAZIENTI 47 – MEDIANA D2B: 90 MINUTIN. PAZIENTI 47 – MEDIANA D2B: 90 MINUTID2B AMMISSIONE PS PO PISTOIAD2B AMMISSIONE PS PO PISTOIA

N. PAZIENTI 45 – MEDIANA D2B: 100 MINUTIN. PAZIENTI 45 – MEDIANA D2B: 100 MINUTID2B AMMISSIONE PS PO PESCIAD2B AMMISSIONE PS PO PESCIA

MIN

UT

I

0

50

100

150

200

250

300

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

UT

I

PAZIENTI

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

Ab

solu

te R

isk

Dif

fere

nce

in D

eath

(%

)

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

F. Van de Werf, ACC 2013

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

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

F. Van de Werf, ACC 2013

no lyticno lytic

STUDY PROTOCOL

RANDOMIZATION 1:1 by IVRS, OPEN LABELRANDOMIZATION 1:1 by IVRS, OPEN LABEL

Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30

Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30

ECG at 90 min: ST resolution ≥ 50%ECG at 90 min: ST resolution ≥ 50%

Standard primary PCI Standard primary PCI

Aspirin Clopidogrel:

LD 300 mg + 75 mg QDEnoxaparin:

30 mg IV + 1 mg/kg SC Q12h

Aspirin Clopidogrel:

LD 300 mg + 75 mg QDEnoxaparin:

30 mg IV + 1 mg/kg SC Q12h

Antiplatelet andantithrombin treatment

according to local standards

Antiplatelet andantithrombin treatment

according to local standards

angio >6 to 24 hrsPCI/CABG if indicated

angio >6 to 24 hrsPCI/CABG if indicated

immediate angio + rescue PCI if

indicated

immediate angio + rescue PCI if

indicated

YES

NO

Strategy A: pharmaco-invasiveStrategy A: pharmaco-invasive Strategy B: primary PCIStrategy B: primary PCI

AspirinClopidogrel:

75 mg QDEnoxaparin:

0.75 mg/kg SC Q12h

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

STEMI <3 hrs from onset symptoms, PPCI <60 min not possible, 2 mm ST-elevation in 2 leads

≥75y: ½ dose TNK≥75y: ½ dose TNK<75y:full dose<75y:full doseAfter 20% of the planned

recruitment, the TNK dose was reduced by

50% among patients ≥75 years of age.

F. Van de Werf, ACC 2013

62

Sx onset1st Medical

contact

61

1 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

F. Van de Werf, ACC 2013

62

Sx onset

61

1 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

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

/Sho

ck/C

HF/

ReM

I (%

)

The 95% CI of the observed incidence in the pharmaco-invasive arm would exclude a 9% relative excess compared with PPCI

F. Van de Werf, ACC 2013

STROKE RATES

 

 

www.escardio.org/guidelines

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 kg

16%

Avo

id

Prasu

grel

Prio

r

CV

A/T

IA4%4%

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

Pri

ma

ry E

nd

po

int

(%)

Prasugrel

Clopidogrel

Prasugrel

Clopidogrel

Loading Dose Maintenance Dose

Timing of BenefitTiming of Benefit(Landmark Analysis)(Landmark Analysis)

www.escardio.org/guidelines

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