Transcript Slide 1
Vascular Protection in High-Risk Non-ST Elevation Acute Coronary Syndromes A ngioplasty B alloon-associated C oronary D ebris and the E F Z ilterWire M Webster Auckland City Hospital Auckland, NZ on behalf of R Whitbourn, D McClean, C Juergens, x H Lowe, G Barbeau , P Matsis, D Walters, G Devlin, xx W Hui, D Brieger, G Tully and the A-F Investigators x – speaker’s honoraria, xx – BSC employee A-F Study Centres Sponsor: Boston Scientific, Mountain View, CA, USA Data Coordinating Centre ECG Core Laboratory HCRI, Boston, USA Canada 3 Australia 7 Angiographic Core Laboratory CRF, New York, USA New Zealand 4 Pathology Core Laboratory Concord Hospital Sydney, Australia A-F Enrolling Centers Center PI St Vincent’s, Melbourne R. Whitbourn Auckland City, Auckland M. Webster Christchurch, Christchurch D. McClean Liverpool, Sydney C. Juergens Laval, Quebec G. Barbeau Wellington, Wellington P. Matsis Prince Charles, Brisbane D. Walters Waikato, Hamilton G. Devlin Royal Alexandra, Edmonton W. Hui Concord, Sydney D. Brieger Box Hill, Melbourne G. New Prince of Wales, Sydney N. Jepson CHUM, Montreal F. Reeves John Hunter, Newcastle S. Thambar Patients 29 32 21 20 9 8 8 6 6 4 3 2 2 1 A-F Native Vessel Coronary Artery Disease Stable Angina Vein Graft Disease Non-ST Elevation Acute Coronary Syndromes ST Elevation MI A-F 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 A-F FilterWire EZ 3.5-5.5mm & 2.25-3.5mm A-F 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 A-F Angiography Shows Coronary Disease Suitable for PCI Lesion / angiographic culprit Fulfils angiographic inclusion criteria TIMI 0-1 flow TIMI 2-3 flow Lesion 2 Lesion 3 Lesion 4 or more Suitable for PCI with FilterWire? Yes No Requires PCI at time of index procedure? Cross with wire ± predilate TIMI 2-3 flow Landing zone adequate Decide re use of GP IIb/IIIa inhibitors Treat as per randomization* No Yes Treat as necessary, staged > 14 days later Exclude Randomize FilterWire EZ Control Position FilterWire Lesion 2,* Lesion 3 PCI / Stent PCI / Stent Lesion 2* Lesion 3 Retrieve FilterWire Angiography Angiography A-F Primary Endpoint In-hospital MACE - death, recurrent myocardial infarction (CK-MB>3x normal), emergency CABG, repeat target vessel revascularisation A-F Secondary Endpoints MACE at 30 days Change in CK-MB 6-24hours post-PCI Change in troponin T 6-24 hours post-PCI Device success – FilterWire EZ Incidence of embolic recovery TIMI flow post-PCI A-F Baseline Characteristics FilterWire EZ Patients, n Age, mean (sd) Male, % European, % Previous angina, % Diabetes, % Smoker – never, % Hypertension, % Dyslipidemia, % 77 58(11) 83 88 40 16 29 39 69 Control 74 60(13) 89 88 42 26 34 46 62 A-F Baseline Angiographic Findings FilterWire EZ Reference vessel, mm Diameter stenosis, % Lesion location - RCA,LAD,LCX ,% Lesion length, mm Lesion ulceration, % Lesion calcification - mod/severe, % TIMI III flow, % 3.1(0.6) 78(14) 37,39,24 15.8(7.6) 5.6 29 60 Control 3.1(0.6) 76(12) 44,32,25 16.8(10.2) 11.2 34 67 A-F Primary Endpoint 15 In hospital MACE, % 10 11.7 9.5 5 p=0.793 0 Filter Wire Control A-F Secondary Endpoints FilterWire EZ MACE 30 day, % Change CK-MB Change troponin T Device success, % Embolic recovery, % 42 Post-PCI TIMI III, % Control 12 5.1(20) 0.4(0.7) 97 11 4.1(6) 0.4(0.6) n/a n/a 94 94 A-F Subset Analyses No difference between FilterWire EZ and control groups in: Patient treated with planned glycoprotein IIb/IIIa inhibitors Diabetic patients Patients pre-treated with clopidogrel Patients with prior thrombolytic therapy A-F 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 calcified vs thrombotic lesions 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 A-F A-F A-F 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 EZ and control groups in in-hospital MACE or post-procedure CK-MB or troponin elevation Routine use of vascular protection devices in such patients does not appear warranted - further angiographic analysis may reveal subgroups at particular risk for embolism A-F