Primary Optimal Percutaneous Coronary Intervention versus Facilitated Intervention in STEMI patients - GRACIA II

Description:

The goal of the GRACIA II trial was to evaluate the safety and efficacy of optimal primary PCI compared with facilitated percutaneous coronary intervention (PCI) with TNK+stenting in patients with ST elevation MI.

Hypothesis:

In patients with STEMI, treatment with facilitated PCI is as effective as optimal primary PCI.

Study Design

Study Design:

Patients Enrolled: 212
Mean Follow Up: 6 months
Mean Patient Age: mean age 63 years
Female: 20%

Patient Populations:

Myocardial infarction within 12 hours of symptom onset with ST elevations.

Primary Endpoints:

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 Endpoints:

Death, MI, ischemic driven revascularization at 6 weeks and 6 months Bleeding events

Drug/Procedures Used:

Patients with acute MI with ST elevation presenting within 12 hours of symptom onset were randomized to optimal primary PCI (within 3 hours with or without abciximab; n=108) or facilitated PCI (n=104). Facilitated PCI patients were treated with TNK bolus and enoxaparin immediately and stent or CABG within 3-12 hours.

Principal Findings:

Median time from randomization to catheterization was 1.1 hours in the primary PCI arm and 5.9 hours in the facilitated PCI arm. Coronary flow at angiography was better in the facilitated PCI arm with higher rates of TIMI flow grade 3 (67.0% vs 13.7%, p < 0.001) and lower TIMI frame counts (20.9 vs 30.6 frames, p=0.034). There was no significant difference in complete ST recovery at 1 hour (15% for facilitated PCI vs 24% for primary PCI, p=0.19) or 3 hours (46% vs 47%, p=0.83) but was more frequent in the facilitated PCI arm at 6 hours (61% vs 43%, p=0.03). Infarct size assessed by CKMB and troponin AUC were similar in both arms. There was no difference between treatment arms in the composite endpoint of death/MI/disabling stroke/ischemic driven revascularization (9.6% vs 12.0%, p=NS) or major bleeding events (1.9% vs 2.8%, p=NS).

Interpretation:

Among patients with ST elevation MI, treatment with facilitated PCI or primary PCI resulted in similar infarct size and early myocardial perfusion by ST resolution, although later ST resolution was improved in the faciliated PCI arm as was epicardial flow. Primary PCI has been shown to be an effective alternative to medical therapy alone in STEMI patients. However, the major limitation to such therapy is limited availability as well as the time delay to transfer and treat the patient in the catheterization lab. Given these limitations, facilitated therapy with early thrombolytic followed by a moderately delayed intervention has been suggested as an alternative to achieve early reperfusion (lytic) followed by more complete reperfusion (PCI). The potential for increased bleeding with facilitated PCI did not occurr in the present trial, although the sample size was small and the study was not powered for safety. The ASSENT-4 PCI trial, which also evaluated facilitated PCI and primary PCI, was discontinued early after increased mortality was observed with facilitated PCI in an interim analysis. However, there are several differences in the study design of ASSENT-4, including only a short delay in time from lytic to PCI in the facilitated group, optional clopidogrel use, and prohibition of GP IIb/IIIa inhibitor use in the facilitated PCI group.

References:

Fernandez-Aviles F, et al. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the Gracia 2 non-inferiority, randomized, controlled trial. Eur Heart J. 2007 Jan 23; Epub before print.

Presented by F. Fernandez-Aviles at the European Society of Cardiology, Vienna, Austria, September 2003.

Clinical Topics: Anticoagulation Management, Dyslipidemia, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Lipid Metabolism, Heart Failure and Cardiac Biomarkers

Keywords: Myocardial Infarction, Stroke, Enoxaparin, Catheterization, Immunoglobulin Fab Fragments, Tissue Plasminogen Activator, Platelet Membrane Glycoprotein IIb, Stents, Troponin, Percutaneous Coronary Intervention


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