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Accumetrics, Inc. Amgen, Inc. AstraZeneca Pharmaceuticals LP Baxter Bayer Healthcare LLC

Outcomes and Optimal Antithrombotic Therapy in Women Undergoing Fibrinolysis for ST-Elevation Myocardial Infarction Jessica L. Mega, MD; David A. Morrow, MD, MPH; Erika Ostor, MD; Maria Dorobantu, MD, PhD; Jie Qin, MS; Elliott M. Antman, MD; Eugene Braunwald, MD. Disclosures.

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Accumetrics, Inc. Amgen, Inc. AstraZeneca Pharmaceuticals LP Baxter Bayer Healthcare LLC

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  1. Outcomes and Optimal Antithrombotic Therapy in WomenUndergoing Fibrinolysis forST-Elevation Myocardial InfarctionJessica L. Mega, MD; David A. Morrow, MD, MPH;Erika Ostor, MD; Maria Dorobantu, MD, PhD; Jie Qin, MS;Elliott M. Antman, MD; Eugene Braunwald, MD

  2. Disclosures The TIMI Study Group has received research / grant support in the past 2 years 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. Background • Since the 1980s, the number of deaths attributed to CVD has been greater for women than men. • Following STEMI, women experience higher rates of reinfarction and death. • Women continue to be under-represented in RCTs, and questions have been raised about treatment-specific outcomes in women post ACS. • ExTRACT – TIMI 25 allowed for the evaluation of the outcomes and optimal antithrombotic treatment strategy in 4,783 women undergoing fibrinolysis for STEMI.

  4. Design 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 N Engl J Med 2006;354:1477-88.

  5. Baseline Characteristics

  6. Clinical Outcomes - Mortality Mortality at 30 Days (%) OR 2.66 95% CI 2.40 – 2.99

  7. Mortality by Age Group Men Women Mortality at 30 Days (%) Age (Yrs) Women (N) 433 305 545 577 822 887 741 317 146 Men (N) 4,502 2,065 2,443 1,909 1,952 1,497 956 296 76

  8. Cumulative Incidence ofPrimary Endpoint WOMEN Relative Risk, 0.84 (95% CI 0.74 – 0.95) P=0.007 Unfractionated Heparin Enoxaparin 18.3% 15.4% 10.1% Death or MI (%) 8.2% MEN Relative Risk, 0.82 (95% CI 0.74 – 0.90) P<0.0001 Days After Randomization

  9. Efficacy and Safety UFH (%) ENOX (%) RRR (%) ARD (%) NNT Day 30 Women 20.8 17.2 17 3.6 28 Death, MI, or Urg Revasc Men 12.6 10.0 21 2.6 38 Women 19.0 16.4 14 2.6 38 Death, MI, or Major Bleed Men 10.9 9.3 14 1.6 63 0.5 1 2 Enoxaparin Better UFH Better

  10. Events per 1,000 Subjects Treated with Enoxaparin Nonfatal Urgent Revascularization Nonfatal TIMI Major Bleeding Death Nonfatal MI + + Number of Events Women Men

  11. Conclusion • Women presented with a profile of higher baseline risk and had increased short-term mortality. • The RRR in Death and nonfatal MI for enoxaparin vs UFH was similar in women and men, with a larger ARD in women. • Although the excess risk of bleeding with enoxaparin was seen for both women and men, net clinical benefit strongly favored enoxaparin in both sexes.

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