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GRACIA-2 Trial: Facilitated vs. Primary PCI in STEMI Patients - ESC 2003 Results

GRACIA-2 Trial compared facilitated and optimal primary PCI in 212 STEMI patients, showing improved angiographic data and ST resolution with facilitated PCI, with similar clinical outcomes and no increased bleeding. Presented at ESC 2003.

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GRACIA-2 Trial: Facilitated vs. Primary PCI in STEMI Patients - ESC 2003 Results

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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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