Presentazione di PowerPoint

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Nuovi orizzonti nel trattamento dellinfarto
miocardico acuto
Learning Center ANMCO, 30 Sett 2002
Carlo Di Mario
Ospedale San Raffaele e Clinica Columbus, Milan,
Italy
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Steering Committee
Principal Investigators
ChevalierIndolfiOlivariSengesSteffeninoStegT
ebbe
Di Mario Bolognese Maillard Zahn
Endorsed by
GISE ANMCO ALKK
Combined Abciximab REteplase Stent Study in Acute
Myocardial Infarction
Supported by research grants Eli Lilly, Biotronik
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Study Design
ST , high risk, lytic eligible, lt 12 h
UFH (40 U/kg (max 3000) 7 U/kg/h)
2 x 5 U bolus (30) Reteplase
Abciximab 0.25 mg/kg bolus 0.125 mg/kg/min x 12 h
(maximum 10 ?g/min)
ELECTIVE PCI
RESCUE PCI
Immediate Transfer to Cath Lab for PCI after PCI
remains in the hospital where PCI was performed
or is transferred back to referring hospital
CCU Admission Transfer for PCI only if
persistent ST elevation at 90 min (gt50 basal
ECG), chest pain or hemodynamic compromise
Death, Reinfarction, Refractory Ischemia at 30
Days
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?Why not PTCA to all patients?
Objection!

• PTCA achieves lower mortality, lower rate of IRA
  reocclusion and reinfarction than thrombolysis.
  Why do you deny the best possible treatment to
  half of your patients?
• .. Right, but only if PTCA is performed in a
  timely fashion, which is not the case for the
  patients included

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ACC/AHA PTCA Guidelines
From Smith et al JACC 2001372215-38
CLASS I
As an alternative to thrombolysis .. if
performed in a timely fashion (lt90 min) by
persons skilled in the procedure and supported by
experienced personnel in an appropriate
laboratory environment
Multiple Randomized Trials Evidence
CLASS IIa
As a reperfusion strategy in candidates to
reperfusion who have a contraindication to
thrombolysis
Weight of evidence in favor of usefulness
CLASS III
Pts eligible for thrombolysis undergoing PCI
performed by low-volume operator (lt75 PTCA/year)
Weight of evidence against use
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PTCA reigns sovereign in Europe
ESC Guidelines Revised

• First choice treatment of ST-elevation acute
  myocardial infarction provided that PTCA can be
  performed within 60 min from hospital admission
  by experienced operators
• .. but what to do if PTCA is not available within
  60 m?

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Primary PCI Door-to-Balloon Time
PAMI 60 min ZWOLLE 64 min GUSTO IIb 114
min PAMI-Stent 110 min
In Trials
In Reality
NRMI (Seattle) 120 (90-270) min GRACE 176
min EURO-HEART 93 (60-170) min BLITZ 85 (60-135)
min Cannon 2000 156 min
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Door-to-balloon time and mortality
27,080 pts with ST AMI in 661 hospitals
(1994-1998)
Median door-to-balloon time 156 min
OR death CI 121 - 150 min 1.41 (1.08-1.84) 151
- 180 min 1.61 (1.23-2.14) gt 180
min 1.61 (1.25-2.08)
Cannon et al JAMA 2000 283 2988-89
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Door-to-Balloon Time and Mortality Advantage of
Primary PTCA over Lysis
Primary PTCA
Lytic
7.0
7.0

6.5
5.7
5.7
5.6
5.5
5.4
2.6
2.0
1.7
PAMI
Zwolle
Wash
NRMI
GUSTO 2B
Florence
60 min
61 min
102 min
120 min
114 min
20.5 min
Courtesy of Dr. Antoniucci
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565 pts in GUSTO IIb
30-day Mortality
6.4
P lt 0.0001
4.0
3.7
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Door-to-balloon time (minutes)
Berger et al Circulation 1999 10014-20
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Reperfusion Therapy for AMI in Europe
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PCI
Lytics

49
46
27
26
21
20
10
7
1
France Germany Italy Spain UK
ENACT, EHJ 2000
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What to do in Community Hospitals?
Transfer Create a hub-spoke network between
community hospitals and CathLab with rapid
transportation
On-Site Make PTCA available in community
hospitals with high volume of AMI admitted
Disadvantages Cost, Operator Experience
Disadvantages Cost, Treatment Delay
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Atlantic Cardiovasc. Patient Outcomes Research
Team (c-PORT)
11 Community Hospitals without on-site surgery
Recruitment 1996-99 Stent 93 ReoPro 76
STEMI lt 12 hrs Door-to-Balloon Time 105 min
PTCA (225 pts)
P0.04
rtPA (226 pts)
10.6
P0.72
7.1
6.2
P0.28
5.3
4.0
2.2
DEATH re-IMA
STROKE
Aversano et al, JAMA 20022871943-51
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Andersen et al ACC 2002
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DANAMI
-
2 Study Design
DANAMI
-
2 Study Design
DANAMI
-
2 Study Design
High
-
risk ST elevation MI patients (
gt
4 mm elevation),
Sx
lt 12 hrs
High
-
risk ST elevation MI patients (
gt
4 mm elevation),
Sx
lt 12 hrs
5 PCI centers (n443) and 22 referring hospitals
(n1,129), tran
sfer in
lt
3 hrs
5 PCI centers (n443) and 22 referring hospitals
(n1,129), tran
sfer in
lt
3 hrs
Primary PCI
Primary PCI
Primary PCI
Primary PCI
Lytic therapy
Lytic therapy
without transfer
without transfer
with transfer
with transfer
Front
-
loaded tPA 100
Front
-
loaded tPA 100
mg
mg
(n223)
(n567)
(n223)
(n567)
(n782)
(n782)
Death / MI / Stroke at 30 Days
Stopped early by safety and efficacy committee
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Andersen et al JACC 2000
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Andersen et al ACC 2002
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1572 pts with AMI treated with Primary PTCA
in 5 PTCA centers from 29 Danish hospitals
30 Days Events
PTCA
Thrombolysis
P0.35
P0.15
P0.0001
7.6
6.6
6.3
2.0
1.6
1.1
DEATH re-IMA
STROKE
DANAMI 2 Investigators ACC 2002
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The PRAGUE-2 Trial
lt 12 hrs STEMI/LBBB, lt120 km distance from PCI
center (68 min average transport 26 min
door-to-balloon)
30 Day Mortality
15.3
10.0
7.4
6.8
7.3
6.0
all pts pts 0-3 hrs pts 3-12 hrs
SK (n 421)
PCI (n 429)
From Widimski et al , ESC Berlin 2002
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The GRACIA trialDesign (N 500)
AMI ( ? ST ) lt 12 h
THROMBOLYSIS (rt-PA)
250 pts
250 pts
RANDOMISATION

• Aspirin
• ? Blockers
• IV Heparin

ANGIOGRAPHY (lt24h)
PREDISCHAGE ANGIO IF ISCHEMIA(SPONTANEOUS /
STRESS)
STENT ELEGIBLE
NON-STENT ELEGIBLE
MEDICAL
SURGICAL
Clinical FU
STENT IRA ADEQUATE REVASCULARIZATION
DISCHARGE (4th-10th day)
SURGERY (before discharge)
Primary EndpointDEATH / RE-AMI /
REVASCULARIZATION AT 30 DAYS 1 YEAR
Clinical FU
Fernandez-Aviles et al, Berlin ESC 2002