ExPORT - ExPORT

Description:

The goal of the Export trial was to evaluate the safety and efficacy of percutaneous coronary intervention (PCI) with thrombus aspiration compared with PCI alone among patients with ST elevation MI.

Study Design

Study Design:

Patients Enrolled: 50
Mean Patient Age: Mean age 61 years

Patient Populations:

ST elevation MI, symptom onset to randomization within 12 hours, initial infarct related artery TIMI flow grade <3

Primary Endpoints:

ST resolution at 1 hour after PCI

Secondary Endpoints:

Myocardial blush grade post-PCI; TIMI frame count; composite of slow flow, no-reflow, and distal embolization; infarct extent on MRI at ~2 days post-PCI

Drug/Procedures Used:

Patients at a single center were randomized to PCI alone (n=26) or PCI with thrombus aspiration with the Export system (n=24). The aspiration system was 6French compatible.

Principal Findings:

Procedural success occurred in 96% of patients in the aspiration group, and debris was removed from 100% of patients. TIMI flow grade improved from a mean of 0.8 pre-aspiration to 2.6 after aspiration (but prior to PCI).

ST resolution >50% at 1 hour post-PCI occurred in 88% of the aspiration group and 62% of the control group (p<0.04). When using a 70% ST resolution threshold, the rates were 50% and 12%, respectively (p<0.01). Post-PCI TIMI Flow Grade 3 did not differ between groups (96% for aspiration group vs 81% for PCI alone group, p=NS), but TIMI frame count was lower in the aspiration group (median 21 vs 32, p<0.04). Myocardial blush grade 3 occurred more frequently in the aspiration group (64% vs 42%, p<0.05). The composite endpoint of slow flow, no-reflow, and distal embolization occurred less frequently in the aspiration group (8% vs 27%, p<0.05).

There was no difference in peak CKMB between groups. However, infarct size at ~2 days post-PCI as assessed by MRI was lower in the aspiration group (15.0% vs 25.6%, p<0.03). There was no difference in clinical events.

Interpretation:

Among patients with ST elevation MI, use of the Export thrombus aspiration system prior to PCI was associated with improvements in ST resolution compared with PCI alone. These benefits did not translate into a clinical benefit at 30 days, although the trial enrolled only 50 patients and was not powered to detect a clinical difference. However, infarct size assessed by MRI was smaller in the aspiration group. These data differ from the results of the much larger EMERALD trial, which showed no benefit of thrombus aspiration prior to PCI compared with PCI alone in patients with ST elevation MI. However, similar results were reported in the smaller REMEDIA trial.

References:

Presented by Dr. Bernard Noel at the EuroPCR meeting, Paris, France, May 2005.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Thrombosis, Stents, Percutaneous Coronary Intervention


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