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Presented at European Society of Cardiology 2003

GRACIA-2 Trial. Primary Optimal Percutaneous Coronary Intervention versus Facilitated Intervention in STEMI patients. Presented at European Society of Cardiology 2003. GRACIA-2 Trial. 212 patients with acute ST elevation MI Presenting within 12 hours of symptom onset

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Presented at European Society of Cardiology 2003

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  1. GRACIA-2 Trial Primary Optimal Percutaneous Coronary Intervention versus Facilitated Intervention in STEMI patients Presented at European Society of Cardiology 2003

  2. GRACIA-2 Trial 212 patients with acute ST elevation MI Presenting within 12 hours of symptom onset Enrolled at 15 centers in Spain and Portugal • Facilitated PCI • TNK bolus and enoxaparin immediately • Stent or CABG within 3-12 hours • (n = 104) • Optimal Primary PCI • PCI within 3 hours, with or without abciximab • (n = 108) • Endpoints (follow-up 6 months): • Primary – 1) Infarct size assessed by area under the curve for CKMB and troponin; 2) myocardial reperfusion by ST resolution at 1, 3, and 6 hours; and 3) LV angio at 6 weeks • Secondary – Death, MI, ischemic driven revascularization at 6 weeks and 6 months; Bleeding events European Society of Cardiology 2003

  3. GRACIA-2 Trial: Results • Trial designed to determine if facilitated PCI is as safe and effective as optimal primary PCI alone • Time from randomization to catheterization: • 1.08 hours in the primary PCI arm • 5.89 hours in the facilitated PCI arm • Infarct size similar in both groups, as was LV ejection fraction evolution at 6 weeks European Society of Cardiology 2003

  4. GRACIA-2 Trial: Epicardial Flow at Initial Angiography TIMI Frame Count p=0.034 TIMI Grade 3 Flow p=0.005 European Society of Cardiology 2003

  5. GRACIA-2 Trial: Complete ST Resolution 6 Hours p=0.03 3 Hours p=0.83 1 Hour p=0.19 European Society of Cardiology 2003

  6. GRACIA-2 Trial: Clinical Events and Bleeding Major Bleed p=0.97 Death / MI / Ischemic Driven Revascularization p=NS European Society of Cardiology 2003

  7. GRACIA-2 Trial • Angiographic data at initial angiography improved with facilitated PCI • Complete ST resolution at 6 hours improved with facilitated PCI • No increased bleeding with facilitated PCI • No significant difference in clinical outcomes, although sample size small (n=212) and underpwoered to show such a difference

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