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The SAFER Trial

The SAFER Trial. “ S VG A ngioplasty F ree of E mboli R andomized”. Evaluation of the Clinical Safety and Efficacy of the PercuSurge GuardWire in Saphenous Vein Graft Intervention As presented at TCT 2000 by: Donald S. Baim, MD FACC Harvard Medical School Brigham and Women’s Hospital.

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The SAFER Trial

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  1. The SAFER Trial • “SVG Angioplasty Free of Emboli Randomized” • Evaluation of the Clinical Safety and Efficacy of the PercuSurge GuardWire in Saphenous Vein Graft Intervention • As presented at TCT 2000 by: • Donald S. Baim, MD FACC • Harvard Medical School • Brigham and Women’s Hospital

  2. The SAFER TrialBackground • The average longevity of a vein graft is 8-10 years • 40% of occlude • 75% develop severe narrowing • Vein graft atherosclerosis is diffuse and friable • Intervention may cause distal embolization • Embolization compromises the distal microcirculation • Manifest as no-reflow (8-10%) and CK elevation (17-20%) • Mortality of 3.4% at 30 days (14% with CK-MB > 3x normal) • A device that could capture and remove embolic particles before they reach the myocardium could reduce these complications

  3. The SAFER TrialPercuSurge GuardWire® System 4 components: GuardWire® EZ-Flator™ MicroSeal® Adapter Export® catheter

  4. The SAFER TrialPercuSurge GuardWire® System A. Lesion crossed with GuardWire® B. GuardWire® balloon inflated and intervention performed under protection. Stent placed with single wire technique

  5. The SAFER TrialPercuSurge GuardWire® System C. Export® Aspiration catheter removes emboli & thrombus with slow distal to proximal pullback D. GuardWire® balloon deflated

  6. The SAFER TrialPercuSurge GuardWire® System

  7. The SAFER Trial • Prior studies: • Webb et al(JACC 34:461, 1999) • single site study of 27 patients • MACE - 3.7% • SAFE(E. Grube, PI) • 103 patient European study (7 sites) • visible material removed in 95% of cases • 81% of material is under 96 micron • MACE - 4.9 % (3.9% non-Q) The randomized SAFER trial was designed as an 800 patient prospective randomized trial to determine if the GuardWire reduced the incidence of MACE compared to conventional, unprotected stenting

  8. The SAFER TrialStudy Management • Study Coordination: Cardiovascular Data Analysis Center (CDAC) • Boston, MA • QCA Core Lab: Brigham and Women’s • Angiographic CoreLaboratory (CDAC) • Boston, MA • ECG Core Lab: Cardiovascular Data Analysis Center (CDAC) Boston, MA • Study Monitoring: Bailer Monitoring • Lake Hopatcong, NJ • Sponsor:PercuSurge, Inc. • Sunnyvale, CA

  9. The SAFER TrialStudy Design • Primary endpoint:“Major Adverse Clinical Events” (MACE) during index hospitalization • A combined clinical endpoint defined as death, Q wave or • Non Q-Wave MI (CK-MB > 3x ULN), emergent bypass surgery, • or repeat target vessel revascularization

  10. The SAFER TrialStudy Design • Inclusion criteria • Lesions (50-100%) in SVG 3-6 mm in diameter • More than 5 mm from ostium; 20 mm from distal anastomosis • At least TIMI 1 flow at baseline • Exclusion criteria • Ongoing MI with + CK-MB • EF < 25%, Cr > 2.5 unless on hemodialysis • Planned use of atherectomy device • Enrollment • 551 patients at 47 sites

  11. The SAFER TrialBaseline Demographics GuardWire (n=273)No GuardWire (n=278) Age (yrs) 68.2 (36, 90) 68.5 (45, 92) Male 80.5% 84.9% History Diabetes Mellitus 31.9% 35.3% Prior MI 59.8% 63.7% Prior CVA/TIA 11.0% 13.1% Worsening exertional 40.1% 39.9% CCS* III or IV 74.8% 74.6% Rest angina 38.6% 37.0% Triple vessel disease 73.7% 80.1% Ejection Fraction Mean 48.3% 47.0%

  12. The SAFER TrialBaseline Lesion Characteristics GuardWireNo GuardWire Pre RVD (mm) 3.45 (1.99, 5.73) 3.47 (1.94, 5.99) MLD (mm) 1.08 (0.00, 3.58) 1.05 (0.00, 3.08) Diameter Stenosis (%) 69.0% 70.1% Lesion Length 15.83 (2.16, 76.99) 17.43 (3.00, 79.29) Target Vessel SVG-LAD 19.7% 17% SVG-LCX 42.8% 41.3% SVG-RCA 37.1% 41.7% Thrombus 38.6% 38.4% Eccentric Lesion 37.6% 34.1% Angulation >45% 6.5% 6.2%

  13. The SAFER Trial Technical Success was defined as successful delivery of the GuardWire to the intended target site, inflation of the occlusion balloon, aspiration using the Export catheter and balloon deflation according to the Instructions For Use Procedure Success was defined as achievement of a final DS < 50% with no in-hospital MACE GuardWireNo GuardWire Technical Success 93.0% n/a Procedure success 90.5% 82.0% Number of stents 1.38 1.35 Inflation time ~ 4 minutes, preliminary observation ~ 2% intolerant

  14. The SAFER TrialResults: Primary Endpoint GuardWire No GuardWire (273 Pts) (278 Pts) • All Myocardial Infarction 8.4% 16.5% - Q Wave MI 1.1% 2.2% - Non Q-Wave MI 7.3% 14.4% • Death 0.7% 1.1% • Emergent CABG 0.0% 0.7% • TLR 0.4% 0.7% MACE @ Index Hospitalization 8.8% 17.3% p=.001

  15. The SAFER TrialResults: MACE 19.8 • 50% (p<0.001) 17.3 • 50% (p<0.001) Percent Incidence 9.9 8.8

  16. The SAFER TrialResults: Secondary Endpoints Post-ProcedureTIMI Flow: GuardWire No GuardWirep-value TIMI 0, 1 1.5% 0.7% 0.440 TIMI 2 0.4% 5.1% 0.001 TIMI 3 98.1% 94.2% 0.025 ------------------------------------------------------------------ No-reflow 3.4% 8.0% 0.026 Perforation 0.4% 1.4% Dissection 1.9% 1.1% Subac. Closure 0.7% 0.7%

  17. The SAFER TrialGP IIb/IIIa Use GP IIb/IIIa inhibitor were used in >60% in both arms, mostly before intervention PercuSurge had MACE benefit with or without them GuardWireNo Guardwire pIIb/IIIa (164 – 182) 11.6% 21.6% 0.007 No IIb/IIIa (109 – 96) 7.3 13.5% 0.17 Why? GP IIb/IIIa’s prevent platelet thrombi, but they do not dissolve atherosclerotic plaque.

  18. The SAFER TrialConclusions • The PercuSurge GuardWire® system proved safe and effective in • recovering potentially embolic material • preserving normal flow • and reducing MACE by 50% • during the percutaneous interventional treatment of saphenous vein bypass grafts • This underscores the importance of distal embolization protection in SVG intervention

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