Published in the European Heart Journal 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

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]

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]

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]

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

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

Post-Fibrinolysis Angioplasty Post-Fibrinolysis Angioplasty GRACIA-2 Trial: TMPG Post-procedural TMPG 3 TMPG 3 at 6 week Follow-up p = 0.04 p <0.001 Endpoint 2 (%) Endpoint 1 (%) n = 78 n = 67 n = 47 n = 24 Post-Fibrinolysis Angioplasty Primary 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]

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]

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]