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St Joseph-St Luc Perret T. Clin. Tonkin Champagnac D. Inf. Protestante Claudel JP. ... ST elevation 1 mm in 2 contiguous limb leads. or 2 mm in 2 contiguous ... – PowerPoint PPT presentation

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Title: Presenter Disclosure Information


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Presenter Disclosure Information
Eric Bonnefoy
The following relationships exist related to this
presentation
Research grants Merck Co, Iroko
Lab Important (provided tirofiban free of
charge for the AGIR2 study) Speakers
honoraria Eli Lilly Modest
24
Comparison of Pre-hospital or Cath lab
Administration of High Dose Tirofiban in
Patients Undergoing Primary AngioplastyThe
AGIR2 Study
Eric Bonnefoy on behalf of AGIR2 investigators
and RESCUe and RESURCOR networksHospices Civils
de Lyon, France
25
Background
  • In patients undergoing primary PCI,
  • GPIIbIIIa inhibitors improve angiographic and
    clinical outcome
  • Early administration of GPIIbIIIa inhibitors
    improved pre-procedural epicardial flow
  • On top of a high loading dose of clopidogrel,
    early high-dose tirofiban improved ST segment
    resolution and clinical outcome
  • The extent of the benefit of pre-hospital
    tirofiban as compared with cath lab tirofiban on
    top of a high loading dose of clopidogrel is
    unknown

26
Rationale
  • If widely applied, pre-hospital initiation of
    GPIIbIIIa inhibitors would
  • require a huge transfer of financial burden to
    emergency units
  • increase the complexity of pre-hospital protocols
    in patients with acute ST segment elevation
    coronary syndrome (STEMI)
  • Such a consequence would be particularly true in
    large emergency medicine-cardiology networks

27
STEMI undergoing primary PCI
Patientcall
600 mg clopidogrel 250 mg aspirin UFH 60 U/kg
inf
MICU
Medical Dispatcher
Randomize Open Label
Pre-hospital
Tirofiban25/0.15
MICUtransportation
Cath lab
Tirofiban25/0.15
Angiography
Angiography
28
Annecy
Lyon
Mont Blanc
11 cath labs
17 MICU
6 central triage centers (randomization)
Grenoble
Valence
20 miles
29
The AGIR2 investigators
RESCUe Network - Coordinator ElKhoury C
RESURCOR Network - Coordinator Belle L
MICU
  • Amberieu Mann Y
  • Annecy Savary D
  • Belley Cognet / Florent O
  • Bourg-en-Bresse Serre P
  • Bourgoin Rodriguez JF
  • CH Croix Rousse Guillaumee F.
  • CH Ed. Herriot Capel O. / Dubien PY
  • CH Lyon sud Fuster P. / David JS.
  • Drôme Nord Genevey P. / Cheval B
  • Grenoble Debaty G
  • Montelimar Busseuil C. / Pajot F
  • Privas Wahiche M
  • Tarare Brilland R
  • Valence Echahed K
  • Vienne Matas O. / Bec JF
  • Villefranche Guillemard T. / Boyer M
  • Voiron Escallier C

Central Triage
SAMU 01 Maupoint R. SAMU 07 Wahiche M. SAMU
26 Echahed K. SAMU 38 Debaty G. SAMU 69 Dubien
PY. SAMU 74 Savary D.
CathLab
HCL L. Pradel Rioufol G. HCL Cx Rousse Besnard
C. St Joseph-St Luc Perret T. Clin.
Tonkin Champagnac D. Inf. Protestante Claudel
JP. Clin. Sauvegarde Hepp A. Valence Chapon
P CH Annecy Belle L. CHU Grenoble Vanzetto
G. Clin. Belledonne Guenot C. Clin.
Mutualiste Bourlard P.
AGIR2 Coordination
Coordination Bonnefoy E, Elkhoury C, Eydoux N,
A Peiretti, Statistical analysis Mercier C,
Bisery A, Ecochard R HCL Plattner V
30
Study designClinicalTrials.gov Identifier
NCT00538317
  • Sponsor University Hospital of Lyon (HCL),
    France
  • Multicenter, randomized, open label comparison
  • Statistical analysis Intention to treat
    Biostatistic Unit - HCL
  • Data management clinical research center - Lyon
  • Data analysis ECGs, biological and procedural
    reports but not coronary angiograms, centrally
    collected and analyzed
  • Merck Co Inc and Iroko Laboratories supplied
    tirofiban free of charge to sponsor

31
Enrollment Criteria
  • Inclusion Criteria
  • gt 18 years
  • Ischemic pain gt 20 min and onset of symptoms lt 12
    hours
  • ST elevation gt 1 mm in 2 contiguous limb leads
    or gt2 mm in 2 contiguous precordial leads
  • Planned primary PCI
  • Informed consent
  • Major Exclusion Criteria
  • High bleeding risk
  • Fibrinolytics or GPIIbIIIa inhibitor lt 7 days
  • Transfer to cath lab gt 90 min

32
End Points
  • Primary endpoint
  • TIMI grade 2-3 flow at initial angiography
  • Key secondary endpoints
  • Complete (gt70) ST segment resolution one hour
    after procedure
  • Troponin I and CK peaks

33
Sample size calculation
  • Initial sample size 300 patients with alpha risk
    5 and 80 power to detect a 16 difference in
    primary endpoint
  • Patients wrongly randomized or who withdrew their
    informed consent before angiography were excluded
    from all analyses
  • With regard to drop-outs, recruitment was
    increased to 337 patients, to have at least 155
    patients in each group

34
Baseline characteristics
35
Angiographic procedures
36
Time intervals and angiography
MICU
Cath lab
83
98
Cath lab Tirofiban
54
26
ANGIO
48
21
Pre-hospitalTirofiban
61
104
85
Times are expressed as median (min)
Plt0.05
37
TIMI grade 2-3 flow first angiography
P0.42
44.2
39.7
Pre-hospital tirofiban
Cath lab tirofiban
38
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39
ST segment resolution gt70
One hour after PCI
P0.64
55.4
52.6
On admission to Cath lab
P0.10
15.2
8.7
Cath lab tirofiban N148
Pre-hospital tirofiban N152
Cath lab tirofiban N127
Pre-hospital tirofiban N112
40
ST segment resolution60 minutes
Residual ST segment 60 minutes
P0.07
P0.32
100
9.5
13.5
15.1
25
22.3
35.1
gt6 mm
32.2
20.4
4-6 mm
lt30
50
1-3 mm
39.9
30-70
30.3
0 mm
gt70
55.4
52.6
24.3
24.3
0
Cath lab tirofiban
Pre-hospital tirofiban
Cath lab tirofiban
Pre-hospital tirofiban
41
Troponins and CK
42
In-hospital events
Cath lab tirofiban
Pre-Hospital tirofiban

p0.15
6
5.5
p0.15
5
3.7
4
p0.29
3.2
3
p0.26
1.9
2
1.3
1.2
0.6
0.6
1
0
Death
Severe Bleeding
Acute stent
Stroke
thrombosis
43
Influence of time from onset of symptoms to
first medical contact

Cath lab tirofiban
Pre-Hospital tirofiban
lt 100 min gt median
65.7
70
56.6
60
51.2
50
48.6
50
39.7
39
37.3
40
30
P0.24
P0.25
P0.83
P0.87
20
10
0
TIMI 2-3
TIMI 2-3
ST 60 min gt70
ST 60 min gt70
P0.39
P0.26
44
Influence of treatment period tirofiban to
angiography
p0.35

70
63.8
p0.11
60
54.3
49.3
46.0
45.5
50
lt10'
40
33.0
10'-45'
30
gt45'
(terciles)
20
10
0
TIMI 2-3 flow
ST 60 min gt70
45
Conclusion
  • Early initiation of tirofiban in pre-hospital
    settings, prior to primary PCI and on top of a
    loading dose of clopidogrel, does not yield
    superior TIMI grade 2-3 flow in the culprit
    artery compared to initiation of tirofiban in the
    cardiac catheterization laboratory
  • No beneficial effects on post-PCI angiography,
    ST-segment resolution or peak troponin levels
    were found

46
Clinical implication
  • The AGIR2 study did not question benefits of
    upfront administration of GPIIbIIIa inhibitors in
    primary PCI
  • Its results do not support the necessity to
    initiate tirofiban administration in pre-hospital
    settings
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