Proximal Protection during Saphenous Vein Graft Intervention using the Proxis™ Embolic Protection System The PROXIMAL Trial Laura Mauri, MD, MSc, FACC,

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Proximal Protection during Saphenous Vein Graft Intervention using the Proxis™ Embolic Protection System The PROXIMAL Trial Laura Mauri, MD, MSc, FACC, David Cox, MD, FACC, James Hermiller, MD, FACC, Joseph Massaro, PhD, Joyce Wahr, MD, Sew Wah Tay, PhD, Michael Jonas, MD, Jeffrey J. Popma, MD, FACC, Jim Pavliska, BS, Dennis Wahr, MD, FACC, Campbell Rogers, MD, FACC, for the PROXIMAL Investigators J Am Coll Cardiol 2007;50:

Mauri L. et. al. J Am Coll Cardiol 2007;50: PROXIMAL: Overview Background: Embolic complications during stenting of degenerated saphenous vein coronary bypass grafts are reduced, but not eliminated, by distal protection. Objectives: To improve outcomes further, we investigated an embolic protection device placed proximal to the target lesion that could provide protection before lesion instrumentation, allow use of conventional guidewires, and permit embolic protection in anatomy unfavorable for distal devices.

Mauri L. et. al. J Am Coll Cardiol 2007;50: PROXIMAL: Background Distal embolic protection using balloon occlusion or filters reduces post- procedural complications during SVG PCI 30 d MACE (%) FIRE Filter Wire 9.9% SAFER unprotected 16.5% 11.6% FIRE Guard Wire 9.6% SAFER Guard Wire PRIDE Tri Active 11.2% PRIDE Filter/ Guard Wire 10.1% Explanations for residual MACE despite distal protection may include embolization during crossing, incomplete capture, and events occurring after device removal

Webb et al: JIC, 2005, 18, 1-3 Angiographic Eligibility for Embolic Protection Among SVG PCI Patients Distal (20%) Proximal, non-ostial (18%) Body of Vein Graft (40%)

Mauri L. et. al. J Am Coll Cardiol 2007;50: PROXIMAL: Study Device Proxis Embolic Protection System (St Jude Medical, Maple Grove, MN) Copyright ©2007 American College of Cardiology Foundation. Restrictions may apply.

Mauri L. et. al. J Am Coll Cardiol 2007;50: PROXIMAL: Methods 594 patients undergoing stenting of 639 saphenous vein grafts were prospectively randomized, using a non- inferiority design to compare two treatment strategies: Control (distal protection whenever possible) or Test (proximal protection when possible, distal when not). The study was designed to test whether a treatment strategy in which proximal protection was used whenever possible would be non-inferior to a strategy of distal protection only. Rejection of the null hypothesis would indicate that the proximal protection strategy would have a primary endpoint rate (30 day MACE) not exceeding that of the distal protection strategy plus a pre-specified non- inferiority margin.

Mauri L. et. al. J Am Coll Cardiol 2007;50: Day MACE: Death, MI (CPK-MB ≥3x ULN), urgent CABG, or Target Vessel Revascularization Power analysis: Assumed event rate for control arm = 12.7% Delta = 7% (55% relative delta) One sided α=0.05 for non-inferiority 560 randomized pts provides 80% power for non- inferiority  600 pts planned PROXIMAL: Primary Endpoint

Mauri L. et. al. J Am Coll Cardiol 2007;50: PROXIMAL: Major Criteria Inclusion: Normal CK/CKMB Lesion(s) in SVG is ≥50% and <100%. Up to 2 SVGs. No limit on number of lesions Concomitant 1-2 native vessel PCI allowed ≥TIMI I Flow Device landing zone RVD ≥3.0 and  5.0 mm Exclusion: MI with 24 hours Cardiac Surgery within 60 days Lesion(s) within 5 mm of proximal anastomotic site LVEF < 20% More than 2 native lesions to be treated More that 2 SVGs to be treated

Mauri L. et. al. J Am Coll Cardiol 2007;50: PROXIMAL: Study Algorithm FilterWire/ GuardWire Control FilterWire/ GuardWire Proxis Randomization No protection Proxis FilterWire/ GuardWire Proxis Proxis™ system Test arm: Use Proxis™ system whenever possible, and FW or GW when Proxis not possible (proximal lesions) Control arm: Use FW/GW whenever possible, and no protection when FW/GW not possible (distal lesions) SVG PCI 594 pts Stratified by GP IIb/IIIa use

Mauri L. et. al. J Am Coll Cardiol 2007;50: Copyright ©2007 American College of Cardiology Foundation. Restrictions may apply. The PROXIMAL Trial

Mauri L. et. al. J Am Coll Cardiol 2007;50: Baseline Clinical Features ControlTestP value N patients Age (mean yrs) NS Male gender84%87%NS Diabetes mellitus44%43%NS Hypertension89%86%NS Hyperlipidemia91% NS Smoker22%20%NS Prior MI60%59%NS Class III/IV angina75%78%NS LVEF (%) NS GP IIb/IIIa blocker use (%) NS

Mauri L. et. al. J Am Coll Cardiol 2007;50: Baseline Angiographic Features ControlTestP value N patients SVG distribution Left Anterior Descending16.6%23.3%NS - Left Circumflex45.1%36.1%NS Right Coronary Artery38.3%40.6%NS Reference Vessel Diameter (mm)3.22 ± ± 0.60NS Minimal Lumen Diameter (mm)1.05± ±0.49NS Diameter stenosis (%)67.32± ±13.35NS SVG degeneration score39.32± ±21.84NS Plaque Volume105.4± ±98.1NS

Mauri L. et. al. J Am Coll Cardiol 2007;50: Δ = -0.8 [-4.8, +3.2] P = for NI Primary Endpoint (30 Day MACE): Intention to Treat

Mauri L. et. al. J Am Coll Cardiol 2007;50: Actual Devices Used Test arm Control arm * *81% FilterWire, 19% GuardWire

Mauri L. et. al. J Am Coll Cardiol 2007;50: Copyright ©2007 American College of Cardiology Foundation. Restrictions may apply. 30-Day MACE Rates

Mauri L. et. al. J Am Coll Cardiol 2007;50: Day MACE: “By Device” Analysis Δ = -4.6 [upper bound 95% CI -0.05] P = for NI *No protection: Primarily distal lesions randomized to Control Arm *

Mauri L. et. al. J Am Coll Cardiol 2007;50: FilterWire/ GuardWire Control FilterWire/ GuardWire Proxis Randomization No protection Proxis FilterWire/ GuardWire Proxis Secondary Analysis: Outcomes in Patients With Lesions Suitable for Either Proximal or Distal Protection

Mauri L. et. al. J Am Coll Cardiol 2007;50: Day MACE: Lesions Amenable to Either Proximal or Distal Protection Δ = -3.1 [-8.2, +2.0] P = for superiority, P = for NI

Mauri L. et. al. J Am Coll Cardiol 2007;50: Copyright ©2007 American College of Cardiology Foundation. Restrictions may apply. Periprocedural Myonecrosis by Intention-to-Treat Analysis Population

Mauri L. et. al. J Am Coll Cardiol 2007;50: Copyright ©2007 American College of Cardiology Foundation. Restrictions may apply. Mauri, L. et al. J Am Coll Cardiol 2007;50: Periprocedural Myonecrosis by Device Analysis Population

Mauri L. et. al. J Am Coll Cardiol 2007;50: Copyright ©2007 American College of Cardiology Foundation. Restrictions may apply. Mauri, L. et al. J Am Coll Cardiol 2007;50: Periprocedural Myonecrosis by Patients Eligible for Treatment With Either Device

Mauri L. et. al. J Am Coll Cardiol 2007;50: PROXIMAL: Conclusion A treatment strategy that included proximal embolic protection whenever possible during treatment of SVG lesions produced outcomes similar to those seen with a strategy using only distal embolic protection. These results support use of proximal protection in eligible lesions.