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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. RESURCOR.

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slide1

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

slide2

RESURCOR

Comparison of Pre-hospital or Cath lab Administration of High Dose Tirofiban in Patients Undergoing Primary AngioplastyThe AGIR2 Study

Eric Bonnefoyon behalf of AGIR2investigators and RESCUe and RESURCOR networksHospices Civils de Lyon, France

background
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
rationale
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

slide5

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

slide6

RESURCOR

Annecy

Lyon

Mont Blanc

11 cath labs

17 MICU

6 central triage centers (randomization)

Grenoble

Valence

20 miles

the agir 2 investigators
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

study design clinicaltrials gov identifier nct00538317
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
enrollment criteria
Enrollment Criteria

Inclusion Criteria

  • > 18 years
  • Ischemic pain > 20 min and onset of symptoms < 12 hours
  • ST elevation > 1 mm in 2 contiguous limb leads or >2 mm in 2 contiguous precordial leads
  • Planned primary PCI
  • Informed consent

Major Exclusion Criteria

  • High bleeding risk
  • Fibrinolytics or GPIIbIIIa inhibitor < 7 days
  • Transfer to cath lab > 90 min
end points
End Points
  • Primary endpoint
  • TIMI grade 2-3 flow at initial angiography
  • Key secondary endpoints
  • Complete (>70%) ST segment resolution one hour after procedure
  • Troponin I and CK peaks
sample size calculation
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
time intervals and angiography
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)

* P<0.05

timi grade 2 3 flow first angiography
TIMI grade 2-3 flow first angiography

P=0.42

44.2%

39.7%

Cath lab tirofiban

Pre-hospital tirofiban

st segment resolution 70
ST segment resolution >70%

One hour after PCI

P=0.64

55.4%

52.6%

On admission to Cath lab

P=0.10

15.2%

8.7%

Cath lab tirofiban

N=127

Pre-hospital tirofiban

N=112

Cath lab tirofiban

N=148

Pre-hospital tirofiban

N=152

slide18

ST segment resolution60 minutes

Residual ST segment 60 minutes

P=0.07

P=0.32

100%

9.5

13.5

15.1

25

22.3

35.1

>6 mm

32.2

20.4

4-6 mm

<30%

50%

1-3 mm

39.9

30-70%

30.3

0 mm

>70%

55.4

52.6

24.3

24.3

0%

Cath lab tirofiban

Cath lab tirofiban

Pre-hospital

tirofiban

Pre-hospital

tirofiban

slide20

In-hospital events

Cath lab tirofiban

Pre-Hospital tirofiban

%

p=0.15

6

5.5

p=0.15

5

3.7

4

p=0.29

3.2

3

p=0.26

1.9

2

1.3

1.2

0.6

0.6

1

0

Death

Severe Bleeding

Acute stent

Stroke

thrombosis

influence of time from onset of symptoms to first medical contact
Influence of time from onset of symptoms to first medical contact

%

Cath lab tirofiban

Pre-Hospital tirofiban

< 100 min >

median

65.7

70

56.6

60

51.2

50

48.6

50

39.7

39

37.3

40

30

P=0.24

P=0.25

P=0.83

P=0.87

20

10

0

TIMI 2-3

TIMI 2-3

ST 60 min >70%

ST 60 min >70%

P=0.39

P=0.26

influence of treatment period tirofiban to angiography
Influence of treatment period tirofiban to angiography

p=0.35

%

70

63.8

p=0.11

60

54.3

49.3

46.0

45.5

50

<10'

40

33.0

10'-45'

30

>45'

(terciles)

20

10

0

TIMI 2-3 flow

ST 60 min >70%

conclusion
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
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

Clinical implication