Mechanical Prevention of Distal Embolization During Primary Angioplasty: Safety, Feasibility, and Impact on Myocardial Reperfusion Ugo Limbruno, MD, PhD; Andrea Micheli, MD; Marco De Carlo, MD; Giovanni Amoroso, MD, PhD; Roberta Rossini, MD; Caterina Palagi, MD, PhD; Vitantonio Di Bello, MD; Anna Sonia Petronio, MD; Gabriella Fontanini, MD; Mario Mariani, MD Circulation. 2003;108:171-176

FilterWire-Ex in Primary PCI 106 patients with acute MI undergoing primary PCI Matched Case-Control Study FilterWire-Ex (FW) A distal embolic protection device Successfully positioned in 89% of patients without complication (n = 53) Matched Control Matched for infarct-related artery, TIMI flow grade, gender and age (n = 53) Endpoints: Primary – Feasibility and safety of adjunctive FW use during primary PCI Secondary – Markers of effective reperfusion (ST resolution, myocardial blush grade, and cTFC); peak CK and CK-MB release, change in LVEF and WMSI at 30 days compared with admission; MACE (death, reinfarction, and need for target vessel revascularization) at 30 days Circulation 2003; 108:171-176

FilterWire-Ex in Primary PCI Corrected TIMI Frame Count p=0.005 Frames Circulation 2003; 108:171-176

FilterWire-Ex in Primary PCI Myocardial Blush Grade 3 p=0.006 Circulation 2003; 108:171-176

FilterWire-Ex in Primary PCI ST-segment Resolution p=0.006 Circulation 2003; 108:171-176

FilterWire-Ex in Primary PCI MACE at 30 Days p=0.488 Circulation 2003; 108:171-176