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ExTRACT-TIMI 25 : New Data

ExTRACT-TIMI 25 : New Data. Elliott M. Antman, MD. This presentation reflects the views of the presenter and does not necessarily reflect the views of the American College of Cardiology Content Distributed by Cardiosource. Disclosure.

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ExTRACT-TIMI 25 : New Data

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  1. ExTRACT-TIMI 25 :New Data Elliott M. Antman, MD This presentation reflects the views of the presenter and does not necessarily reflect the views of the American College of Cardiology Content Distributed by Cardiosource

  2. Disclosure The TIMI Study Group has received research / grant support in the past 2 yrs through the Brigham & Women’s Hospital with funding from (in alphabetical order): The National Institutes of Health Integrated Therapeutics Corporation KAI Pharmaceuticals Merck & Co., Inc. Millennium Pharmaceuticals, Inc. Novartis Pharmaceuticals Nuvelo, Inc. Ortho-Clinical Diagnostics, Inc. Pfizer, Inc. Roche Diagnostics Corporation Roche Diagnostics GmbH Sanofi-Aventis Sanofi-Synthelabo Recherche Schering-Plough Research Institute St Jude Medical Accumetrics, Inc. Amgen, Inc. AstraZeneca Pharmaceuticals LP Baxter Bayer Healthcare LLC Beckman Coulter, Inc. Biosite Incorporated Bristol-Myers Squibb CardioKinetix CV Therapeutics, Inc. Eli Lilly and Company FoldRx GlaxoSmithKline INO Therapeutics LLC Inotek Pharmaceuticals Corporation

  3. Protocol Design N Engl J Med 2006;354:1477-88. STEMI < 6 hLytic eligible Lytic choice by MD(TNK, tPA, rPA, SK) ASA Double-blind, double-dummy ENOX < 75 y: 30 mg IV bolus SC 1.0 mg / kg q 12 h (Hosp DC) ≥ 75 y: No bolusSC 0.75 mg / kg q 12 h (Hosp DC) CrCl < 30: 1.0 mg / kg q 24h UFH60 U / kg bolus (4000 U) Inf 12 U / kg / h (1000 U / h)Duration: at least 48 hCont’d at MD discretion Day 301° Efficacy Endpoint: Death or Nonfatal MI1° Safety Endpoint: TIMI Major Hemorrhage

  4. Main Results N Engl J Med 2006;354:1477-88. Main Secondary Endpoint: Death, non-fatal re-MI, urgent revascularization by 30 days Primary Endpoint: Death or non-fatal re-MI by 30 days UFH UFH 14.5 12.0 11.7 9.9 ENOX ENOX % % RR = 0.83 p = 0.000003 RR = 0.81 p = 0.000001 Days Days 12% RRR in by 48 h (P=0.02) 33% RRR in reMI by 48 h (P=0.002) 19% RRR in Death/MI by 72 h (P<0.001)

  5. Death or Nonfatal MITreatment Effect Over Time UFH(%) ENOX (%) RRR (%) ARD(%) NNT 1 4.1 3.6 11 0.5 200 2 5.2 4.7 10 0.5 200 P<0.001 3 6.7 5.4 19 1.3 77 Days From Rand. 4 7.5 5.9 22 1.6 63 5 8.2 6.4 22 1.8 56 6 8.7 6.8 22 1.9 53 7 9.2 7.1 22 2.1 48 9.3 7.2 23 2.1 48 8 ENOX Better UFH Better 0.5 1 2 RR

  6. Bleeding Endpoints (TIMI) 30 Days N Engl J Med 2006;354:1477-88. UFH ENOX ARD 0.7%RR 1.53P<0.0001 ARD 0.4%RR 1.84P = 0.001 ARD 0.4%RR 1.39P = 0.014 ARD 0.1%RR 1.27P = 0.14 % Events Major Bleed(Total) FatalMajor Bleed NonfatalMajor Bleed ICH

  7. Net Clinical Benefit at 30 Days N Engl J Med 2006;354:1477-88. Prespecified Definitions UFH (%) ENOX (%) RRR (%) Death or Nonfatal MI or Nonfatal Disabl. Stroke 12.3 10.1 18 P <0.0001 Death or Nonfatal MI or Nonfatal Major Bleed 12.8 11.0 14 P <0.0001 Death or Nonfatal MI or Nonfatal ICH 12.2 10.1 17 P <0.0001 0.8 0.9 1 1.25 ENOX Better RR UFH Better

  8. For Every 1000 Pts Treated with Enoxaparin N Engl J Med 2006;354:1477-88. + (No increase in nonfatal ICH) Events / 1000 Pts Nonfatal reMI Urgent Revasc. Death Nonfatal TIMI Major Bleed

  9. For Every 1000 Pts Treated with EnoxaparinAge < 75 vs > 75 AHA 2006 Events / 1000 Pts Nonfatal reMI Nonfatal Urgent Revasc. Death Nonfatal TIMI Major Bleed

  10. For Every 1000 Pts Treated with EnoxaparinGender (No increase in nonfatal ICH) Events / 1000 Pts Nonfatal TIMI Major Bleed Death NFMI UR

  11. For Every 1000 Pts Treated with EnoxaparinDiabetes AHA 2006 (No increase in nonfatal ICH) Events / 1000 Pts Nonfatal TIMI Major Bleedp = 0.21p = 0.04 Deathp = 0.039p = 0.39 NFMIp = 0.011p < 0.0001 URp = 0.76p = 0.0006 DMNo DM

  12. For Every 1000 Pts Treated with EnoxaparinClopidogrel Use (No PCI) AHA 2006 Death, MI, Rec Isch, Stroke Nonfatal Major Bleed Events / 1000 Pts No Clopidogrel Clopidogrel Used

  13. Death or Nonfatal MI - Day 30 Lytic Administered AHA 2006 UFH (%) ENOX (%) RRR (%) SK (N=4139) 11.8 10.2 13 TNK (N=3986) 11.5 9.4 18 rPA (N=1122) 11.4 8.4 27 12.2 10.1 17 tPA (N=11,175) 1 0.5 2 ENOX Better UFH Better Interaction TestsP = NS RR

  14. Clinical Implication A strategy ofENOX is clearly preferable to the current standard of UFH as the antithrombin to support fibrinolysis, the most common form of reperfusion for STEMI used worldwide.

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