GRACIA-2 Trial
Primary Optimal Percutaneous Coronary
Intervention versus Facilitated Intervention in STEMI
patients
Presented at
European Society of Cardiology 2003
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
Optimal Primary PCI
 PCI within 3 hours, with or
without abciximab
(n = 108)
Facilitated PCI
 TNK bolus and enoxaparin immediately
 Stent or CABG within 3-12 hours
(n = 104)
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
www. Clinical trial results.org
European Society of Cardiology 2003
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
www. Clinical trial results.org
European Society of Cardiology 2003
GRACIA-2 Trial: Epicardial Flow at Initial
Angiography
TIMI Grade 3 Flow
TIMI Frame Count
p=0.005
p=0.034
35
70%
59%
60%
30.6
30
50%
25
40%
20
30%
15
20%
20.9
10
14%
10%
5
0%
0
Primary PCI
Facilitated PCI
www. Clinical trial results.org
Primary PCI
Facilitated PCI
European Society of Cardiology 2003
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%
20%
15.0%
0%
www. Clinical trial results.org
Primary PCI
Facilitated PCI
European Society of Cardiology 2003
GRACIA-2 Trial: Clinical Events and Bleeding
Major Bleed
Death / MI / Ischemic Driven
Revascularization
15%
p=0.97
4%
p=NS
12%
3%
10%
3.0%
9%
2.0%
2%
5%
1%
0%
Primary PCI
Facilitated PCI
www. Clinical trial results.org
0%
Primary PCI
Facilitated PCI
European Society of Cardiology 2003
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
www. Clinical trial results.org