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HOT LINE PRESENTATION World Congress of Cardiology 2006

Warfarin Antiplatelet Vascular Evaluation - 2161 PAD Patients Dr. Sonia Anand Associate Professor of Medicine McMaster University. HOT LINE PRESENTATION World Congress of Cardiology 2006 Barcelona, Spain September 5, 2006. Rationale. Atherosclerosis is a systemic disease

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HOT LINE PRESENTATION World Congress of Cardiology 2006

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  1. Warfarin Antiplatelet Vascular Evaluation- 2161 PAD PatientsDr. Sonia AnandAssociate Professor of MedicineMcMaster University HOT LINE PRESENTATION World Congress of Cardiology 2006 Barcelona, Spain September 5, 2006

  2. Rationale • Atherosclerosis is a systemic disease • PAD patients suffer the highest rates of CV death, MI, and ischemic stroke • Antiplatelet therapy reduces CV events in broad spectrum of patients with vascular disease (CAD, CBVD, PAD) • Role of Oral anticoagulants (OAC) together with antiplatelets in CAD appears promising

  3. Primary Objectives • To determine if moderate intensity OAC (INR 2-3), in combination with antiplatelet therapy, is superior to antiplatelet therapy alone in preventing • cardiovascular death, MI, or stroke, and • cardiovascular death, MI, stroke, or severe ischemia of the coronary or peripheral arterial circulation

  4. Study Design • Central Randomization, Open trial, Blinded adjudication, 80 Centres, 7 Countries PAD Patients AP only (1,081 patients) AP only Run-In Rand Follow-up - q 3 mo. x 30-42 mo. 2-4 weeks AP + OAC (INR 1.8-3.5) AP + OAC AP + OAC (1,080 patients) 3 mo. 6 mo. 9 mo. Day 35 42 mo.or Final Visit

  5. Key Inclusion/Exclusion Criteria Inclusion: • Men and women, 35-85 years plus >1 of • Intermittent claudication with objective evidence of PAD (e.g. ABI <0.9) • Previous vascular reconstruction (including amputation) or angioplasty of a peripheral artery • Significant carotid artery disease • Prior Vascular disease and ABI < 0.9 Exclusion: • - Active bleeding or high-risk for bleeding • Clear indication for long-term OAC use • Clear indication for long-term (> 3 months) daily NSAIDs • Recent Stroke < 6 months

  6. Key Outcomes Efficacy • Co-Primary 1: CV death, MI, or stroke • Co-Primary 2: CV death, MI, stroke, or severe ischemia of the coronary or peripheral arterial circulation • Life-threatening bleeding: Fatal or intra-cranial, or requiring surgical intervention, or transfusion of at least 4 units of blood products • Moderate bleeding: < 3 units of blood products Safety

  7. Flow of Patients 2,417 eligible patients enter active run-in 256 stopped Run-in 115 patient decision 66 minor bleeding or unstable INR values 50 poor adherence 25 other reasons 2,161 patients randomized 1,080 allocated to oral 1,081 allocated to antiplatelet anticoagulation therapy plus therapy alone antiplatelet therapy Mean INR = 2.2 0 lost to follow-up 2 lost to follow-up 21 permanently discontinued 319 permanently discontinued antiplatelet therapy oral anticoagulants 1 bleeding 126 bleeding 20 other reasons 129 patient / physician decision 45 began oral anticoagulants 64 other reasons 12 atrial fibrillation 10 venous thromboembolism 12 patient / physician decision 2 prosthetic heart valves 9 other reasons 1,080 analyzed 1,081 analyzed Mean INR = 2.2

  8. Baseline Characteristics

  9. Primary Outcomes Note: P1 =composite of CV death, MI, stroke; P2= CV death, MI, stroke, SI of limb or coronaries

  10. Figure 2a Co-Primary 1: CV Death, MI, Stroke OAC+AP AP

  11. Figure 2b Co-Primary 2: CV Death, MI, Stroke, Severe Ischemia OAC+AP AP

  12. Safety Outcomes

  13. Life-Threatening Bleeding OAC+AP AP

  14. Life-Threatening or Moderate Bleeding Life-Threatening or Moderate Bleeding OAC+AP AP

  15. Summary 1) Oral anticoagulants (targeting an INR range of 2 to 3) added to Antiplatelet therapy do not lower the rate of cardiovascular events, and increase life-threatening bleeding compared to Antiplatelet therapy alone in patients peripheral arterial disease. 2) Other antithrombins with a better safety profile or dual antiplatelet agents should be evaluated in this population

  16. Study Organization Australia: Eikelboom, 1 centre, 16 patients; Canada: Anand, 26 centres, 880 patients; China: Liu, 18 centres, 347 patients; Hungary: Keltai, 8 centres, 85 patients; Netherlands: van Urk, 1 centre, 18 patients; Poland: Budaj, 15 centres, 566 patients; Ukraine: Parkhomenko, 11 centres, 249 patients. DSMB chair: Dagenais; Adjudication chair: Sussex. Project office: Anand, Yusuf, Chin, Joldersma, Xie, Antaya, Sloane, Nowacki, Parkinson

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