1. Angioplasty Balloon-associated Coronary Debris and the EZ FilterWire
Vascular Protection in High-Risk Non-ST Elevation Acute Coronary Syndromes
Angioplasty Balloon-associated Coronary Debris and the EZ FilterWire
M Webster
Auckland City Hospital
Auckland, NZ
on behalf of R Whitbourn, D McLean, C Juergens, H Lowe, G Barbeau, P Matsis, D Walters, G Devlin, W Hui, D Brieger, G Tully and the A-F Investigators

2. Study Design
Prospective, multicenter, unblinded, two-arm, randomized trial
Selected high-risk patients with nonSTEMI acute coronary syndromes
PCI using the BSC FilterWire vs standard PCI without FilterWire
150 patient pilot for pivotal protocol
Provision for two additional cohorts
- up to 450 patients

3. Study Population
Non ST elevation ACS with "high risk" clinical features during 24 hours prior to angiography
elevated troponin
angina at rest
dynamic ST or T wave changes (not ST elevation MI)
Culprit lesion with "high risk" angiographic features (2 or more of the following)
intra-coronary filling deficit consistent with thrombus
lesion ulceration
eccentric shape
irregular or scalloped border
abrupt edges to the lesion
lesion length >20 mm

4. Primary Endpoint In-hospital MACE
- death, recurrent myocardial infarction (CK-MB>3x normal), emergency CABG, repeat target vessel revascularisation

5. Baseline Characteristics
FilterWire Control
Patients, n
Age, mean (sd) 58(11) 60(13)
Male, %
European, %
Previous angina, %
Diabetes, %
Smoker – never, %
Hypertension, %
Dyslipidemia, %

6. Primary Endpoint

7. Secondary Endpoints FilterWire Control MACE 30 day, % 12 11
Change CK-MB (20) 4.1(6)
Change troponin T (0.7) 0.4(0.6)
Device success, % n/a
Embolic recovery, % n/a
Post-PCI TIMI III, %

8. Why Was There No Benefit With FilterWire?
Wrong patho-physiology?
embolism occurs during PCI for nonSTEMI
- histology, thrombectomy, MRI
Wrong lesions selected?
only 42% had emboli captured
Incomplete protection?
embolism with positioning the device
filter mouth/ vessel wall apposition
incomplete side branch protection
small particle embolism
Insufficient study population
- type II error

9. Summary
A-F is the only randomised trial of a vascular protection device undertaken in non-STEMI acute coronary syndrome patients
No difference between FilterWire and control groups in in-hospital MACE or post-proceure CK-MB or troponin elevation
Routine use of vascular protection devices in such patients does not appear warranted