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Vascular Protection in High-Risk Non-ST Elevation Acute Coronary Syndromes
Angioplasty Balloon-associated Coronary Debris and the EZ FilterWire
M WebsterM Webster Auckland City HospitalAuckland City Hospital
Auckland, NZAuckland, NZ
on behalf of R Whitbourn, D McClean, C Juergens, on behalf of R Whitbourn, D McClean, C Juergens, H Lowe, G BarbeauH Lowe, G Barbeauxx
, P Matsis, D Walters, G , P Matsis, D Walters, G Devlin, W Hui, D Brieger, G TullyDevlin, W Hui, D Brieger, G Tullyxxxx
and the A-F and the A-F InvestigatorsInvestigators
x – speaker’s honoraria, xx – BSC employeex – speaker’s honoraria, xx – BSC employee
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Study Centres
Canada 3
Australia 7
New Zealand 4
Data Coordinating CentreECG Core LaboratoryHCRI, Boston, USA
Angiographic Core LaboratoryCRF, New York, USA
Pathology Core LaboratoryConcord Hospital Sydney, Australia
Sponsor: Boston Scientific, Mountain View, CA, USA
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Enrolling Centers CenterCenter PI PI Patients Patients
St Vincent’s, MelbourneSt Vincent’s, Melbourne R. Whitbourn R. Whitbourn 3232 Auckland City, AucklandAuckland City, Auckland M. Webster M. Webster 2929 Christchurch, ChristchurchChristchurch, Christchurch D. McClean D. McClean 2121 Liverpool, SydneyLiverpool, Sydney C. Juergens C. Juergens 2020 Laval, QuebecLaval, Quebec G. Barbeau G. Barbeau 9 9 Wellington, WellingtonWellington, Wellington P. Matsis P. Matsis 8 8 Prince Charles, BrisbanePrince Charles, Brisbane D. Walters D. Walters 8 8 Waikato, HamiltonWaikato, Hamilton G. Devlin G. Devlin 6 6 Royal Alexandra, EdmontonRoyal Alexandra, Edmonton W. Hui W. Hui 6 6 Concord, SydneyConcord, Sydney D. Brieger D. Brieger 4 4 Box Hill, MelbourneBox Hill, Melbourne G. New G. New 3 3 Prince of Wales, SydneyPrince of Wales, Sydney N. Jepson N. Jepson 2 2 CHUM, MontrealCHUM, Montreal F. Reeves F. Reeves 2 2 John Hunter, NewcastleJohn Hunter, Newcastle S. Thambar S. Thambar 1 1
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Native Vessel Coronary Artery
Disease
Vein GraftDisease
Stable Angina
ST Elevation MI
Non-ST Elevation
Acute Coronary Syndromes
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Study Design
• Prospective, multicenter, unblinded, two-arm, randomized
trial• Selected high-risk patients with nonSTEMI acute coronary
syndromes• PCI using the BSC FilterWire EZ vs standard PCI without
FilterWire EZ• 150 patient pilot for pivotal protocol• Provision for two additional cohorts
- up to 450 patients
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FilterWire EZ 3.5-5.5mm & 2.25-3.5mm
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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
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Lesion 2 Lesion 3Lesion 4 or more
TIMI 0-1 flow TIMI 2-3 flow Yes No
Cross with wire ± predilate
TIMI 2-3 flow Landing zone adequate
No Yes
Treat as per randomization*
Treat as necessary,
staged > 14 days later
Exclude
FilterWire EZ Control
Position FilterWire
Lesion 2,* Lesion 2*
Lesion 3 PCI / Stent PCI / Stent Lesion 3
Retrieve FilterWire
Angiography Angiography
Randomize
Angiography Shows Coronary Disease Suitable for PCI
Requires PCI at time of index procedure?
Decide re use of GP IIb/IIIa inhibitors
Fulfils angiographic inclusion criteria Suitable for PCI with FilterWire?
Lesion / angiographic culprit
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Primary Endpoint
In-hospital MACEIn-hospital MACE
- death, recurrent myocardial - death, recurrent myocardial infarction (CK-MB>3x normal), infarction (CK-MB>3x normal), emergency CABG, repeat target emergency CABG, repeat target vessel revascularisationvessel revascularisation
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Secondary Endpoints
MACE at 30 daysMACE at 30 days Change in CK-MB 6-24hours post-PCIChange in CK-MB 6-24hours post-PCI Change in troponin T 6-24 hours post-PCIChange in troponin T 6-24 hours post-PCI Device success – FilterWire EZDevice success – FilterWire EZ Incidence of embolic recoveryIncidence of embolic recovery TIMI flow post-PCITIMI flow post-PCI
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Baseline Characteristics
FilterWire EZ ControlFilterWire EZ Control
Patients, nPatients, n 77 77 7474Age, mean (sd)Age, mean (sd) 58(11) 58(11) 60(13)60(13)Male, %Male, % 83 83 8989European, %European, % 88 88 8888Previous angina, %Previous angina, % 40 40 4242Diabetes, %Diabetes, % 16 16 2626Smoker – never, %Smoker – never, % 29 29 3434Hypertension, %Hypertension, % 39 39 4646Dyslipidemia, %Dyslipidemia, % 69 69 6262
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Baseline Angiographic Findings
FilterWire EZ ControlFilterWire EZ Control
Reference vessel, mmReference vessel, mm 3.1(0.6)3.1(0.6)3.1(0.6)3.1(0.6)
Diameter stenosis, %Diameter stenosis, % 78(14)78(14) 76(12)76(12)Lesion location - RCA,LAD,LCXLesion location - RCA,LAD,LCX ,%,% 37,39,2437,39,24 44,32,2544,32,25Lesion length, mmLesion length, mm 15.8(7.6)15.8(7.6)
16.8(10.2)16.8(10.2)Lesion ulceration, % Lesion ulceration, % 5.65.6 11.211.2Lesion calcification - mod/severe, %Lesion calcification - mod/severe, % 2929 34 34TIMI III flow, %TIMI III flow, % 6060 67 67
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Primary Endpoint
p=0.793p=0.793
11.7
9.5
0
5
10
15
Filter Wire Control
In hospitalMACE, %
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Secondary Endpoints
FilterWire EZ ControlFilterWire EZ Control
MACE 30 day, %MACE 30 day, % 12 12 11 11
Change CK-MBChange CK-MB 5.1(20) 5.1(20) 4.1(6)4.1(6)
Change troponin TChange troponin T 0.4(0.7) 0.4(0.7) 0.4(0.6)0.4(0.6)
Device success, %Device success, % 97 97 n/a n/a
Embolic recovery, %Embolic recovery, % 42 42 n/a n/a
Post-PCI TIMI III, %Post-PCI TIMI III, % 94 94 94 94
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Subset Analyses
No difference between FilterWire EZ and No difference between FilterWire EZ and control groups in:control groups in:
Patient treated with planned glycoprotein Patient treated with planned glycoprotein IIb/IIIa inhibitorsIIb/IIIa inhibitors
Diabetic patientsDiabetic patientsPatients pre-treated with clopidogrelPatients pre-treated with clopidogrelPatients with prior thrombolytic therapy Patients with prior thrombolytic therapy
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Why Was There No Benefit With FilterWire?
Wrong patho-physiology? Wrong patho-physiology? embolism occurs during PCI for nonSTEMIembolism occurs during PCI for nonSTEMI- histology, thrombectomy, MRI- histology, thrombectomy, MRI
Wrong lesions selected?Wrong lesions selected?only 42% had emboli capturedonly 42% had emboli capturedcalcified vs thrombotic lesionscalcified vs thrombotic lesions
Incomplete protection? Incomplete protection? embolism with positioning the deviceembolism with positioning the devicefilter mouth/ vessel wall appositionfilter mouth/ vessel wall appositionincomplete side branch protectionincomplete side branch protectionsmall particle embolismsmall particle embolism
Insufficient study population?Insufficient study population?- type II error- type II error
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Summary
A-F is the only randomised trial of a A-F is the only randomised trial of a vascular protection device undertaken in vascular protection device undertaken in non-STEMI acute coronary syndrome non-STEMI acute coronary syndrome patientspatients
No difference between FilterWire EZ and No difference between FilterWire EZ and control groups in in-hospital MACE or post-control groups in in-hospital MACE or post-procedure CK-MB or troponin elevationprocedure CK-MB or troponin elevation
Routine use of vascular protection devices Routine use of vascular protection devices in such patients does not appear warrantedin such patients does not appear warranted- further angiographic analysis may reveal - further angiographic analysis may reveal sub-groups at particular risk for embolismsub-groups at particular risk for embolism