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The ACUITY Trial randomized 13,819 patients with moderate and high-risk NSTE-ACS.

Major Bleeding Is Associated With Increased One-Year Mortality and Ischemic Events in Patients With ACS: Results From the ACUITY Trial. Steven V. Manoukian, Frederick Feit, Steven R. Steinhubl, Michele D. Voeltz, George D. Dangas, Ramin Ebrahimi, Roxana Mehran, and Gregg W. Stone

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The ACUITY Trial randomized 13,819 patients with moderate and high-risk NSTE-ACS.

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  1. Major Bleeding Is Associated With Increased One-Year Mortality and Ischemic Events in Patients With ACS: Results From the ACUITY Trial Steven V. Manoukian, Frederick Feit, Steven R. Steinhubl, Michele D. Voeltz, George D. Dangas, Ramin Ebrahimi, Roxana Mehran, and Gregg W. Stone Emory University School of Medicine, Atlanta, GA; New York University School of Medicine, New York, NY; University of Kentucky, Lexington, KY; Columbia University Medical Center and The Cardiovascular Research Foundation, New York, NY; University of California Los Angeles and the Greater Los Angeles VA Medical Center, Los Angeles, CA

  2. UFH or Enoxaparin + GP IIb/IIIa Bivalirudin + GP IIb/IIIa Angiography within 72h R* Bivalirudin Alone STUDY DESIGN • The ACUITY Trial randomized 13,819 patients with moderate and high-risk NSTE-ACS. Medical management Moderate- high risk ACS PCI Aspirin in all Clopidogrel dosing and timing per local practice CABG

  3. PNI <0.001 PSup = 0.015 PNI <0.001 PSup <0.001 PNI = 0.011 PSup = 0.32 ACUITY Primary Results – 30 Days

  4. ACUITY Primary Results – 1 Year

  5. BACKGROUND & OBJECTIVES • Major bleeding is a significant complication of acute coronary syndromes (ACS). • Major bleeding is associated with increased 30-day mortality and ischemic event rates. • Bivalirudin alone results in lower rates of major bleeding vs. heparin + GPI strategies. • We evaluated the impact of major bleeding on 1-year outcomes in patients with ACS from the ACUITY Trial.

  6. Baseline Characteristics

  7. Major Bleeding and 30-Day Event Rates P<0.0001 for all

  8. P<0.001 30-Day Major Bleeding by Treatment

  9. P<0.0001 for all Major Bleeding and 1-Year Event Rates

  10. Major Bleeding and 30-Day Mortality

  11. Predictors of 30-Day Major Bleeding

  12. Predictors of 1-Year Mortality

  13. CONCLUSIONS • 645 patients (4.7%) had major bleeding by 30 days. • Major bleeding is an independent predictor of one-year mortality and is associated with increased rates of ischemic events at one year in patients with ACS. • Treatment with bivalirudin monotherapy significantly lowers rates of bleeding compared to treatment with heparin + GPI.

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