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 Enrolled at 15 centers in Spain and Portugal Optimal Primary PCI PCI within 3 hours, with or without abciximab (n = 108) Facilitated PCI TNK bolus and enoxaparin immediately Stent or CABG within 3-12 hours (n = 104) 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

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

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

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

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

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