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HART-II : Background

HART-II : Background. Advantages of Antithrombotic Agents in AMI:

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HART-II : Background

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  1. HART-II : Background Advantages of Antithrombotic Agents in AMI: May promote speed and efficacy of thrombolysis May suppress the rate of rethrombosisThe safety and efficacy of low molecular weight heparins have not been compared to unfractionated heparin when used in combination with thrombolytic agents in ST segment elevation MI A Ross, Late Breaking Clinical Trial Results, ACC 2000

  2. HART-IIProtocol Design N = 400 ST  MI < 12H Age > 18 years ASA and tPA, 100 mg Front Loaded 90 min regimen Enoxaparin 30 mg IV bolus 1 mg/kg SC at 15” Q12 hrs for 72 hrs Unfractionated Heparin 5,000 u bolus (4,000 < 67kg) 15 unit/kg IV infusion for 77 hrs Endpoints: Blinded Core Lab Analysis of IRA patency at 90 min and 5-7 days Safety A Ross, Late Breaking Clinical Trial Results, ACC 2000

  3. HART-II : Clinical Sites Steering Committee Members Merril Knudtson, MD - Canada Conor Lundergan, MD - USA Peter Molhoek, MD - The Netherlands Allan M. Ross, MD, Chaiman - USA * * * DSMB Members Pierre Théroux, MD, Chairman - Canada Marcel van de Brand, MD - The Netherlands Werner Hacke, MD - Germany David Sheps, MD - USA Freek Verheurgt, MD - The Netherlands Janet Wittes, PhD - USA Principal Sponsor Aventis (RPR) Operations Bert de Jong, MD - USA Yasmine Draoui, MS - USA Lorna Regalado - USA Whitney Schwartz - USA A Ross, Late Breaking Clinical Trial Results, ACC 2000

  4. HART-II : Baseline Variables Unfractionated Enoxaparin Heparin Mean Age (yrs) 61.0 59.5 Male Gender (%) 74.0 78.0 Mean Weight (kg) 78.0 81.1 Time, Pain to Rx (hrs) 3.3 3.2 Current Smoker (%) 49.0 48.5 Prior MI (%) 13.5 11.0 LAD Infarct (%) 32.8 37.7 A Ross, Late Breaking Clinical Trial Results, ACC 2000

  5. HART-II : IRA Patency at 90 Minutes 81.1 75.1 p =NS 47.6 52.9 A Ross, Late Breaking Clinical Trial Results, ACC 2000

  6. HART-II : Equivalence Analysis IRA Patency at 90 min 85.9 80.1 74.4 Enox 81.3 69.0 UFH 90 85 80 75.1 70 65 60 Patency, % A Ross, Late Breaking Clinical Trial Results, ACC 2000

  7. HART-II : Equivalence Analysis Hypothesis : Enoxaparin is not inferior to unfractionated heparin, with a minimum acceptable difference of 10% (Delta) in patency (TIMI 2+3 flow) Conclusion of Equivalence Difference in patency rate [ ] -10% -2% 05% (observed delta) 12% Conclusion: The lower bound of the 90% CI of the difference in patency between Enox and UFHis -2%, far from the -10%equivalence limit, and close to the superiority limit (0) : equivalence hypothesis is confirmed A Ross, Late Breaking Clinical Trial Results, ACC 2000

  8. HART-II : Reocclusion within one Week TIMI 2, 3  0, 1 TIMI 3  0, 1 % UFU Enox UFU Enox A Ross, Late Breaking Clinical Trial Results, ACC 2000

  9. HART-II : Clinical Events • Bleeding • Intracranial Hemorrhage 2 (1.0%) 2 (1.0%) • Major Hemorrhage (TIMI) 3.0% 3.6% • Transfusion  2U pRBC 7.1% 5.6% • Hgb decline  3gm/dl 10.7% 12.8% • Fatalities • In Hospital 4.5% 4.0% • 30 day 5.0% 5.0% UFH Enox A Ross, Late Breaking Clinical Trial Results, ACC 2000

  10. HART- II: Conclusions • Trend toward higher 90 minute patency with enoxaparin vs. unfractionated heparin • Trend toward less frequent reocclusion of IRA with enoxaparin • Similar rates of major bleeding with enoxaparin and UFH A Ross, Late Breaking Clinical Trial Results, ACC 2000

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