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Primary Optimal Percutaneous Coronary Intervention versus Facilitated Intervention in STEMI patients

GRACIA-2 Trial. Primary Optimal Percutaneous Coronary Intervention versus Facilitated Intervention in STEMI patients.

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Primary Optimal Percutaneous Coronary Intervention versus Facilitated Intervention in STEMI patients

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  1. GRACIA-2 Trial Primary Optimal Percutaneous Coronary Intervention versus Facilitated Intervention in STEMI patients Francisco Fernandez-Aviles, Joaquin J. Alonso, Gonzalo Pena, Jesus Blanco, Jose Moreu, Rosa A. Hernandez, Alfonso Castro-Beiras, Rafael Gabriel, C. Michael Gibson, Pedro L. Sanchez for the GRACIA-2 Investigators Published in the European Heart Journal

  2. GRACIA-2 Trial: Study Design 212 patients with acute ST-segment elevation myocardial infarction presenting within 12 hours of symptom onset. Enrolled at 15 centers in Spain and Portugal. Randomized. Mean age: 63 years. Mean follow-up: 12 months R Optimal Primary PCI PCI within 3 hours, with or without abciximab n=108 Facilitated PCI TNK bolus and enoxaparin Stent or CABG within 3-12 hours n = 104 6 month follow-up • Primary Endpoint: 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 Endpoint: Death, MI, ischemic driven revascularization at 6 weeks and 6 months; Bleeding events Eur Heart J. 2007 Jan 23; [Epub ahead of print]

  3. GRACIA-2 Trial: Background • In patients with acute myocardial infarction and ST-elevation myocardial infarction (STEMI), primary angioplasty is frequently not available or performed beyond the recommended time limit. • The purpose of this study was to evaluate whether lytic-based early routine angioplasty represents a reasonable reperfusion option for victims of STEMI irrespective of geographic or logistical barriers. Eur Heart J. 2007 Jan 23; [Epub ahead of print]

  4. GRACIA-2 Trial: Epicardial Flow at Initial Angiography TIMI Grade 3 Flow p=0.005 TIMI Frame Count p=0.034 • Angiographic data at initial angiography improved with facilitated PCI Eur Heart J. 2007 Jan 23; [Epub ahead of print]

  5. GRACIA-2 Trial: Complete ST Resolution 6 Hours p=0.03 3 Hours p=0.83 1 Hour p=0.19 • Complete ST resolution at 6 hours improved with facilitated PCI Eur Heart J. 2007 Jan 23; [Epub ahead of print]

  6. GRACIA-2 Trial: Clinical Events and Bleeding Major Bleed p=0.97 Death / MI / Ischemic Driven Revascularization p=NS • There was no increased bleeding with facilitated PCI Eur Heart J. 2007 Jan 23; [Epub ahead of print]

  7. GRACIA-2 Trial: TMPG TMPG 3 at 6 week Follow-up Post-procedural TMPG 3 p = 0.04 p <0.001 Endpoint 2 (%) Endpoint 1 (%) n = 67 n = 78 n = 24 n = 47 Primary Angioplasty Post-Fibrinolysis Angioplasty Post-Fibrinolysis Angioplasty Primary Angioplasty • The post-procedural and 6-week TMPG 3 rates were higher in the early routine post-fibrinolysis angioplasty group (50 vs 25.3%, p<0.001 and 83 vs 70.6%, p=0.04; respectively) Eur Heart J. 2007 Jan 23; [Epub ahead of print]

  8. GRACIA-2 Trial: Limitations • As a comparison between strategies involving different invasive procedures and time windows, this study was necessarily open-labeled. • The study is underpowered for clinical events and safety and a larger clinical outcome study for confirmation of the results is needed. • This trial also did not address the issue of rescue angioplasty for failed fibrinolysis. Eur Heart J. 2007 Jan 23; [Epub ahead of print]

  9. GRACIA-2 Trial: Summary • Early routine post-fibrinolysis angioplasty safely results in better myocardial perfusion than primary angioplasty. • Despite its later application, this approach appears to be equivalent to primary angioplasty in limiting infarct size and preserving left ventricular function. Eur Heart J. 2007 Jan 23; [Epub ahead of print]

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