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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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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. RESURCOR Annecy Lyon Mont Blanc 11 cath labs 17 MICU 6 central triage centers (randomization) Grenoble Valence 20 miles

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Baseline characteristics

  13. Angiographic procedures

  14. 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

  15. TIMI grade 2-3 flow first angiography P=0.42 44.2% 39.7% Cath lab tirofiban Pre-hospital tirofiban

  16. 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

  17. 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

  18. Troponins and CK

  19. 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

  20. 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

  21. 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%

  22. 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

  23. 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

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