Management dell’Infarto Miocardico

Acuto a presentazione
“sopralivellamento del tratto ST”

STEMI
Linee Guida ESC 2012
 Time to Reperfusion and Outcome
100
Mortality reduction (%)
Potential
80 D outcomes

A-B – no benefit
60 B-C – benefit ?
% C A-C – benefit
D-C – harm
40
B A
20
Extent of salvage (% of area at risk)
0
1 3 6 12 12-24
Time to treatment is critical
Opening the IRA PPCI>lysis

Gersh JAMA 2005

Tcheng J Am Coll Cardiol 48:1336, 2006 13
System
delay
Patient
Delay

www.escardio.org/guidelines
 Percoso STEMI pistoia
Cardiologo UTIC

1 accesso
FMC Trasporto monitoraggio diretto
Accessosala
Diagnosi diretto sala
Ecg teletrasmesso
per 1PTCA

Percorso+ attivazione sala

Emodinamista reperibile
& staff : infermiere/TRS

Ritardo di sistema
STEMI ENTRO 12 ORE ANNO 2012

N.TOTALE 173
PAZIENTI 0 RESCUE

0 POST-TL

PCI PRIMARIA 173

64 26 83
37% 15% 48%
DIRETTA TRASFERITA AMMESSA
AL CL DA SPOKE AD HUB
 D2B TOTALE PAZIENTI N. 173
N. PAZIENTI 173 – MEDIANA D2B: 90 MINUTI
350

300

250

200
MINUTI

150

100

50

0
0 20 40 60 80 100 120 140 160 180 200

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
350

300

250
MINUTI

200

150

100

50

0
0 5 10 15 20 25 30 35 40 45 50

PAZIENTI
 PCI di trasferimento tra PO
N. PAZIENTI 26 – MEDIANA D2B: 125 MINUTI
350

300

250

200
MINUTI

150

100

50

0
0 5 10 15 20 25 30

PAZIENTI
 Motality benefit of primary PCI declines with
“PCI-related time delay”
10 −
Absolute Risk Difference in Death (%)

13 RCTs
N = 5494
P = 0.04

5−
Favors
PCI Mortality equipose:
60 min
0−

Favors fibrinolysis with

a fibrin-specific agent
-5 − ┬ ┬ ┬ ┬ ┬ ┬
30 40 50 60 70 80

PCI-Related Time Delay (minutes)

Nallamothu and Bates. Am J Cardiol 2003;92:824.
36
F. Van de Werf, ACC 2013
BACKGROUND

• 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

F. Van de Werf, ACC 2013

STUDY AIM

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.

F. Van de Werf, ACC 2013

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 A: pharmaco-invasive Strategy B: primary PCI

After≥75y:
20%½ofdosetheTNKplanned
Ambulance/ER

<75y:full dose no lytic

recruitment, the TNK
Aspirin
Clopidogrel:
dose was reduced by
Aspirin
Clopidogrel:
Antiplatelet and
antithrombin treatment
LD 300 mg + 75 mg QD 50% among 75 mgpatients
QD ≥75 according to local
Enoxaparin: Enoxaparin:
30 mg IV + 1 mg/kg SC years
0.75 mg/kgof
SCage.
Q12h standards
Q12h
ECG at 90 min: ST resolution ≥ 50%
PCI Hospital

YE N
S immediate O
angio +
angio >6 to 24 hrs
rescue PCI if Standard primary PCI
PCI/CABG if indicated
indicated

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

day 30
F. Van de Werf, ACC 2013
 MEDIAN TIMES TO TREATMENT (min)
1st Medical Randomize IVRS
Sx onset contact
Rx TNK

62 29 9 100
min

1st Medical
78 min
Sx onset contact Randomize IVRS difference
Rx PPCI

61 31 86
n=1892 1 Hour 2 Hours 178 min
F. Van de Werf, ACC 2013
 MEDIAN TIMES TO TREATMENT (min)
1st Medical Randomize IVRS
Sx onset contact
Rx TNK
36% Rescue PCI at 2.2h

62 29 9 100 min
64% non-urgent cath at 17h

1st Medical
Sx onset contact Randomize IVRS
Rx PPCI

61 31 86
n=1892 1 Hour 2 Hours 178 min
F. Van de Werf, ACC 2013
PRIMARY ENDPOINT
TNK vs PPCI
Dth/Shock/CHF/ReMI (%) Relative Risk 0.86, 95%CI (0.68-1.09)
PPCI 14.3%
TNK 12.4%
p=0.24
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
Pharmaco-invasive PPCI P-value

TOTAL POPULATION (N=1892)

Total stroke 15/939 (1.60%) 5/946 (0.53%) 0.03

fatal stroke 7/939 (0.75%) 4/946 (0.42%) 0.39
Haemorrhagic stroke 9/939 (0.96%) 2/946 (0.21%) 0.04
fatal haemorrhagic stroke 6/939 (0.64%) 2/946 (0.21%) 0.18

POST AMENDMENT POPULATION (N=1503)

Total stroke 9/747 (1.20%) 5/756 (0.66%) 0.30

fatal stroke 3/747 (0.40%) 4/756 (0.53%) >0.999
Haemorrhagic stroke 4/747 (0.54%) 2/756 (0.26%) 0.45
fatal haemorrhagic stroke 2/747 (0.27%) 2/756 (0.26%) >0.999

F. Van de Werf, ACC 2013

www.escardio.org/guidelines
 Bleeding Risk Subgroups
Therapeutic Considerations

16%

4%

Significant
MD Net Clinical Benefit
10 mg with Prasugrel
80%
 Timing of Benefit
(Landmark Analysis)
8
Primary Endpoint (%)

6.9
Clopidogrel Clopidogrel
6 5.6 5.6

4
4.7
Prasugrel Prasugrel

2
HR 0.82 HR 0.80
P=0.01 P=0.003
1

0 0
0 1 2 3 30 60 90 180 270 360 450

Loading Dose Days Maintenance Dose

www.escardio.org/guidelines
PLATO - STEMI substudy - Outcomes

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)

Steg P.G., et al. Circulation 2010;122:2131-2141