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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
Clinical Trial Results . org
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
Facilitated PCI
PCI within 3 hours, with or without
abciximab
TNK bolus and enoxaparin
Stent or CABG within 3-12 hours
n=108
n = 104
6 month follow-up
пЃ§
пЃ§
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
Clinical Trial Results . org
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.
Clinical Trial Results . org
Eur Heart J. 2007 Jan 23; [Epub ahead of print]
GRACIA-2 Trial: Epicardial Flow at Initial
Angiography
TIMI Grade 3 Flow
TIMI Frame Count
p=0.005
p=0.034
70%
35
59%
60%
30
50%
25
40%
20
30%
15
20%
20.9
10
14%
5
10%
0%
30.6
• Angiographic
data at initial
angiography
improved with
facilitated PCI
0
Primary PCI
Clinical Trial Results . org
Facilitated PCI
Primary PCI
Facilitated PCI
Eur Heart J. 2007 Jan 23; [Epub ahead of print]
GRACIA-2 Trial: Complete ST Resolution
100%
80%
1 Hour
3 Hours
6 Hours
p=0.19
p=0.83
p=0.03
61.0%
60%
47.0% 46.0%
43.0%
40%
24.0%
15.0%
20%
0%
Primary PCI
Facilitated PCI
•Complete ST resolution at 6 hours improved with facilitated PCI
Clinical Trial Results . org
Eur Heart J. 2007 Jan 23; [Epub ahead of print]
GRACIA-2 Trial: Clinical Events and Bleeding
Major Bleed
Death / MI / Ischemic Driven
Revascularization
p=NS
15%
12%
3%
10%
p=0.97
4%
3.0%
9%
2.0%
2%
5%
1%
0%
Primary PCI
Facilitated PCI
0%
Primary PCI
Facilitated PCI
• There was no increased bleeding with facilitated PCI
Clinical Trial Results . org
Eur Heart J. 2007 Jan 23; [Epub ahead of print]
GRACIA-2 Trial: TMPG
TMPG 3 at 6 week Follow-up
Post-procedural TMPG 3
90%
60%
50.0%
50%
83.0%
80%
p <0.001
p = 0.04
70.6%
70%
60%
30%
25.3%
20%
10%
n = 47
n = 24
0%
PostFibrinolysis
Angioplasty
Primary
Angioplasty
Endpoint 2 (%)
Endpoint 1 (%)
40%
50%
40%
30%
20%
10%
n = 78
n = 67
0%
PostFibrinolysis
Angioplasty
Primary
Angioplasty
• The post-procedural and 6-week TMPG 3 rates were higher in the early routine postfibrinolysis angioplasty group (50 vs 25.3%, p<0.001 and 83 vs 70.6%, p=0.04; respectively)
Clinical Trial Results . org
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]
Clinical Trial Results . org
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.
Clinical Trial Results . org
Eur Heart J. 2007 Jan 23; [Epub ahead of print]
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