1. 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

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 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 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 Jan 23; [Epub ahead of print]

5. 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 Jan 23; [Epub ahead of print]

6. 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 Jan 23; [Epub ahead of print]

7. 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 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 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 Jan 23; [Epub ahead of print]