Vascular Protection in High-Risk Non–ST-Elevation Acute Coronary Syndromes: The Angioplasty Balloon-Associated Coronary Debris and the EZ FilterWire - A-F — Presented at SCAI-ACC i2 Summit/ACC 2008

Mar 30, 2008
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Trial Sponsor:
Boston Scientific
Date Presented:
01/01/2008
Date Updated:
03/30/2008
Original Posted Date:
03/30/2008
References

Description:

The goal of this trial was to evaluate major adverse cardiac events (MACE) after embolic protection with the EZ FilterWire followed by stenting, compared with stenting alone among non–ST-elevation acute coronary syndrome (NSTE-ACS) patients.

Hypothesis:

A strategy of embolic protection and stenting among NSTE-ACS patients will be more effective in reducing MACE than stenting alone.

Study Design

Study Design:

Patients Enrolled: 151
Mean Follow Up: In-hospital
Mean Patient Age: 59 years
Female: 14

Patient Populations:

• NSTE-ACS with increased clinical and angiographic risk for distal embolization
• Increased clinical risk for distal embolization: dynamic ischemic electrocardiographic changes, rest angina, elevated cardiac enzymes
• Increased angiographic risk for distal embolization: visible thrombus, ulceration, eccentric lesion, irregular border, abrupt lesion edges, lesion length >20 mm

Primary Endpoints:

• In-hospital MACE
• MACE defined as death, MI, or emergency repeat revascularization

Secondary Endpoints:

• 30-day MACE
• Change in CK-MB or troponin T 6-24 hours after the intervention
• Device success
• Incidence of embolic recovery
• TIMI flow after the intervention

Drug/Procedures Used:

NSTE-ACS patients were randomized to embolic protection and stenting (n = 77) or stenting alone (n = 74).

Principal Findings:

There were 16% diabetics in the embolic protection group and 26% in the control group. The reference vessel diameter was 3.1 mm in both groups. Lesion length was 15.8 mm and 16.8 mm, respectively.

The FilterWire was successfully used in 97% of the patients with no device-related complications. There was evidence of embolic recovery in 42% of patients. The primary endpoint of in-hospital MACE occurred in 11.7% of the FilterWire group versus 9.5% of the control group. MACE at 30 days was 12% versus 11%, respectively.

The increase in cardiac enzymes was similar between the two groups: creatine kinase-myocardial band (CK-MB) was 5.1 versus 4.1, and troponin T was 0.4 versus 0.4, respectively. TIMI 3 flow after the intervention was 94% in both groups. There was no difference among any subgroup tested: planned glycoprotein IIb/IIIa inhibitor, diabetics, pretreatment with clopidogrel, or prior thrombolytic therapy.

Interpretation:

This trial is similar to the recent DEDICATION trial, which found no benefit of embolic protection and stenting during myocardial infarction. The contradistinction between these two trials is that DEDICATION studied ST-elevation myocardial infarction (STEMI), whereas A-F studied non-STEMI. There is now an accumulating body of evidence documenting that embolic protection during MI is feasible, although this strategy does not appear to be beneficial in improving myocardial reperfusion or improving clinical outcomes. This technology remains best suited for saphenous vein graft interventions.

References:

Vascular Protection in High-Risk Non–ST-Elevation Acute Coronary Syndromes: The Angioplasty Balloon-Associated Coronary Debris and the EZ FilterWire (A-F) Randomized, Controlled Trial. Presented by Dr. Mark Webster at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.

Keywords: Thrombolytic Therapy, Acute Coronary Syndrome, Myocardial Infarction, Creatine Kinase, MB Form, Troponin T, Coronary Disease, Ticlopidine, Thrombosis, Saphenous Vein, Diabetes Mellitus, Myocardial Reperfusion, Platelet Glycoprotein GPIIb-IIIa Complex


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