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Vascular Protection in High-Risk Non-ST Elevation Acute Coronary Syndromes

Vascular Protection in High-Risk Non-ST Elevation Acute Coronary Syndromes A ngioplasty B alloon-associated C oronary D ebris and the E Z F ilterWire. M Webster Auckland City Hospital Auckland, NZ

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Vascular Protection in High-Risk Non-ST Elevation Acute Coronary Syndromes

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  1. Vascular Protection in High-Risk Non-ST Elevation Acute Coronary Syndromes AngioplastyBalloon-associatedCoronaryDebris and theEZFilterWire M Webster Auckland City Hospital Auckland, NZ on behalf of R Whitbourn, D McClean, C Juergens, H Lowe, G Barbeaux, P Matsis, D Walters, G Devlin, W Hui, D Brieger, G Tullyxx and the A-F Investigators x – speaker’s honoraria, xx – BSC employee

  2. Study Centres Canada 3 Sponsor: Boston Scientific, Mountain View, CA, USA Data Coordinating Centre ECG Core Laboratory HCRI, Boston, USA Australia 7 Angiographic Core Laboratory CRF, New York, USA New Zealand 4 Pathology Core Laboratory Concord Hospital Sydney, Australia

  3. Center PI Patients St Vincent’s, Melbourne R. Whitbourn 32 Auckland City, Auckland M. Webster 29 Christchurch, Christchurch D. McClean 21 Liverpool, Sydney C. Juergens 20 Laval, Quebec G. Barbeau 9 Wellington, Wellington P. Matsis 8 Prince Charles, Brisbane D. Walters 8 Waikato, Hamilton G. Devlin 6 Royal Alexandra, Edmonton W. Hui 6 Concord, Sydney D. Brieger 4 Box Hill, Melbourne G. New 3 Prince of Wales, Sydney N. Jepson 2 CHUM, Montreal F. Reeves 2 John Hunter, Newcastle S. Thambar 1 Enrolling Centers

  4. 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

  5. FilterWire EZ 3.5-5.5mm & 2.25-3.5mm

  6. 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

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

  8. 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

  9. Baseline Characteristics FilterWire EZ Control Patients, n 77 74 Age, mean (sd) 58(11) 60(13) Male, % 83 89 European, % 88 88 Previous angina, % 40 42 Diabetes, % 16 26 Smoker – never, % 29 34 Hypertension, % 39 46 Dyslipidemia, % 69 62

  10. Baseline Angiographic Findings FilterWire EZ Control Reference vessel, mm 3.1(0.6) 3.1(0.6) Diameter stenosis, % 78(14) 76(12) Lesion location - RCA,LAD,LCX ,% 37,39,24 44,32,25 Lesion length, mm 15.8(7.6) 16.8(10.2) Lesion ulceration, % 5.6 11.2 Lesion calcification - mod/severe, % 29 34 TIMI III flow, % 60 67

  11. p=0.793 Primary Endpoint

  12. Secondary Endpoints FilterWire EZ Control MACE 30 day, % 12 11 Change CK-MB 5.1(20) 4.1(6) Change troponin T 0.4(0.7) 0.4(0.6) Device success, % 97 n/a Embolic recovery, % 42 n/a Post-PCI TIMI III, % 94 94

  13. 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

  14. 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

  15. 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 sub-groups at particular risk for embolism

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