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
outcomes
80 D
60
A-B – no benefit
B-C – benefit ?
A-C – benefit
D-C – harm
C
%
40
B
A
20
Extent of salvage (% of area at risk)
0
1
3
6
Time to treatment is critical
12
12-24
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
FMC
Diagnosi
Ecg teletrasmesso
Trasporto monitoraggio
1 accesso
diretto
sala
Accesso
diretto sala
per 1PTCA
Percorso+ attivazione sala
Emodinamista reperibile
& staff : infermiere/TRS
Ritardo di sistema
STEMI ENTRO 12 ORE ANNO 2012
N.TOTALE
PAZIENTI
173
PCI PRIMARIA
64
173
26
0
RESCUE
0
POST-TL
83
37%
15%
48%
DIRETTA
AL CL
TRASFERITA
DA SPOKE
AMMESSA
AD HUB
D2B TOTALE PAZIENTI N. 173
N. PAZIENTI 173 – MEDIANA D2B: 90 MINUTI
350
300
250
MINUTI
200
150
100
50
0
0
20
40
60
80
100
PAZIENTI
120
140
160
180
200
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
MINUTI
250
200
150
100
50
0
0
5
10
15
20
25
PAZIENTI
30
35
40
45
50
PCI di trasferimento tra PO
N. PAZIENTI 26 – MEDIANA D2B: 125 MINUTI
350
300
250
MINUTI
200
150
100
50
0
0
5
10
15
PAZIENTI
20
25
30
Absolute Risk Difference in Death (%)
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
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
Ambulance/ER
Strategy A: pharmaco-invasive
<75y:full dose
Aspirin
Clopidogrel:
LD 300 mg + 75 mg QD
Enoxaparin:
30 mg IV + 1 mg/kg SC
Q12h
After≥75y:
20%½ofdose
theTNK
planned
recruitment, the TNK
Aspirin
dose was
reduced by
Clopidogrel:
75 mgpatients
QD
50% among
≥75
Enoxaparin:
years
0.75
mg/kgof
SCage.
Q12h
Strategy B: primary PCI
no lytic
Antiplatelet and
antithrombin treatment
according to local
standards
PCI Hospital
ECG at 90 min: ST resolution ≥ 50%
YE
S
angio >6 to 24 hrs
PCI/CABG if indicated
N
immediate O
angio +
rescue PCI if
indicated
Standard primary PCI
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
contact
Sx onset
Rx TNK
62
29
1st Medical
contact
Sx onset
61
n=1892
Randomize IVRS
9
100
min
Randomize IVRS
78 min
difference
31
1 Hour
Rx PPCI
86
2 Hours
178 min
F. Van de Werf, ACC 2013
MEDIAN TIMES TO TREATMENT (min)
1st Medical
contact
Sx onset
Randomize IVRS
Rx TNK
36% Rescue PCI at 2.2h
62
29
9 100 min
64% non-urgent cath at 17h
1st Medical
contact
Sx onset
61
n=1892
Randomize IVRS
31
1 Hour
Rx PPCI
86
2 Hours
178 min
F. Van de Werf, ACC 2013
Dth/Shock/CHF/ReMI (%)
PRIMARY ENDPOINT
TNK vs PPCI
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
15/939 (1.60%)
5/946 (0.53%)
0.03
7/939 (0.75%)
4/946 (0.42%)
0.39
9/939 (0.96%)
2/946 (0.21%)
0.04
6/939 (0.64%)
2/946 (0.21%)
0.18
9/747 (1.20%)
5/756 (0.66%)
0.30
3/747 (0.40%)
4/756 (0.53%)
>0.999
4/747 (0.54%)
2/756 (0.26%)
0.45
2/747 (0.27%)
2/756 (0.26%)
>0.999
TOTAL POPULATION (N=1892)
Total stroke
fatal stroke
Haemorrhagic stroke
fatal haemorrhagic stroke
POST AMENDMENT POPULATION (N=1503)
Total stroke
fatal stroke
Haemorrhagic stroke
fatal haemorrhagic stroke
F. Van de Werf, ACC 2013
www.escardio.org/guidelines
Bleeding Risk Subgroups
Therapeutic Considerations
16%
4%
MD
10 mg
Significant
Net Clinical Benefit
with Prasugrel
80%
Timing of Benefit
(Landmark Analysis)
Primary Endpoint (%)
8
Clopidogrel
6
5.6
4
4.7
5.6
Prasugrel
Prasugrel
HR 0.82
P=0.01
2
6.9
Clopidogrel
HR 0.80
P=0.003
1
0
0
1
2
Loading Dose
3
0
30 60 90
Days
180
270
360
Maintenance Dose
450
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