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OASIS-5

OASIS-5. The Fifth O rganization to A ssess S trategies in Acute I schemic S yndromes trial. US hospital discharges in ACS. Acute coronary syndromes. 1.67 million hospital discharges/year. UA/NSTEMI. STEMI. 1.17 million. 500,000. AHA. Heart Disease and Stroke Statistics–2005 Update.

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OASIS-5

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  1. OASIS-5 The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes trial

  2. US hospital discharges in ACS Acute coronary syndromes 1.67 million hospital discharges/year UA/NSTEMI STEMI 1.17 million 500,000 AHA. Heart Disease and Stroke Statistics–2005 Update.

  3. OASIS-5: Background • The combined use of anticoagulants, antiplatelet agents, and invasive coronary procedures in a routine early invasive strategy reduces ischemic coronary events but also increases bleeding in selected patients with ACS • OASIS-5 was conducted to assess whether fondaparinux, a selective inhibitor of factor Xa, would preserve the anti-ischemic benefits of enoxaparin and further reduce bleeding MICHELANGELO OASIS 5 Steering Committee. Am Heart J. 2005;150:1107-14.OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  4. OASIS-5: Hypotheses In the acute treatment of patients with UA/NSTEMI fondaparinux is: • Noninferior to enoxaparin in preventing death, MI, or refractory ischemia through day 9 • Superior to enoxaparin as determined by lower major bleeding events through day 9 • Superior to enoxaparin in benefit/risk balance as determined by lower rate of death, MI, refractory ischemia, and major bleeding MICHELANGELO OASIS 5 Steering Committee. Am Heart J. 2005;150:1107-14.OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  5. OASIS-5: Study design Patients with NSTE ACS, chest discomfort <24 hours,2: Age >60 y,  ST segment,  cardiac biomarkers ASA, clopidogrel, GP IIb/IIIa,planned cath/PCI per local practice Randomize N = 20,078 Fondaparinux2.5 mg sc qd Enoxaparin1 mg/kg sc bid Outcomes Primary: Efficacy Death, MI, refractory ischemia at 9 d Safety Major bleeding at 9 d Benefit/risk Death, MI, refractory ischemia, major bleeding at 9 d Secondary: Primary outcomes plus each component at 30 d and 6 mo MICHELANGELO OASIS 5 Steering Committee. Am Heart J. 2005;150:1107-14.

  6. OASIS-5: Baseline characteristics OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  7. OASIS-5: Medical history % OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  8. OASIS-5: Concomitant in-hospital medications following randomization % OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  9. OASIS-5: Treatment effect on primary efficacy outcome at 9 days Death, MI, refractory ischemia HR 1.01 0.06 (0.90-1.13) 0.05 Fondaparinux 0.04 Cumulativeevent rate 0.03 0.02 Enoxaparin 0.01 0 0 1 2 3 4 5 6 7 8 9 Time (days) OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  10. OASIS-5: Treatment effect on primary safety outcome at 9 days Major bleeding 0.06 Enoxaparin 0.04 HR 0.52 (0.44-0.61) P < 0.001 0.03 Cumulativeevent rate 0.02 Fondaparinux 0.01 0 0 1 2 3 4 5 6 7 8 9 Time (days) OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  11. OASIS-5: Net clinical benefit at 9 days Death, MI, refractory ischemia, major bleeding HR 0.81 (0.73-0.89) 0.08 P < 0.001 Enoxaparin 0.06 Fondaparinux Cumulativeevent rate 0.04 0.02 0 0 1 2 3 4 5 6 7 8 9 Time (days) OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  12. OASIS-5: Primary and secondary efficacy outcomes at 9 days Enoxaparin (n = 10,021) Fondaparinux (n = 10,057) 5.7 5.8 4.1 4.1 1.9 1.8 2.7 2.6 1.9 1.9 % Fondaparinuxbetter Enoxaparin better Death/MI/RI Prespecifiednoninferiority margin = 1.185 P = 0.007 Death/MI Death MI RI 0.6 0.8 1 1.2 Hazard ratio (95% CI) OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76. RI = refractory ischemia

  13. OASIS-5: Primary and secondary efficacy outcomes at 30 days % Fondaparinux (n = 10,057) Enoxaparin (n = 10,021) Fondaparinuxbetter Enoxaparin better Death/MI/RI* 8.0 8.6 Death/MI 6.2 6.8 Death† 2.9 3.5 MI 3.9 4.1 RI 2.2 2.2 0.6 0.8 1 1.2 Hazard ratio *P = 0.13†P = 0.02 OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  14. OASIS-5: Death, MI, refractory ischemia at 6 months Enoxaparin HR 0.93(0.86-1.00) P = 0.06 0.14 0.12 Fondaparinux 0.10 Cumulativeevent rate 0.08 0.06 0.04 0.02 0 0 20 40 60 80 100 120 140 160 180 Time (days) OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  15. OASIS-5: Net clinical benefit at 6 months Death, MI, refractory ischemia, major bleeding HR 0.86(0.81-0.93) P < 0.001 Enoxaparin 0.20 0.15 Fondaparinux 0.10 Cumulativeevent rate 0.05 0 0 20 40 60 80 100 120 140 160 180 Time (days) OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  16. OASIS-5: Primary and secondary efficacy outcomes at 6 months Enoxaparin (n = 10,021) Fondaparinux (n = 10,057) 13.2 12.3 11.4 10.5 6.5 5.8 6.6 6.3 2.4 2.3 % Fondaparinuxbetter Enoxaparin better Death/MI/RI* Death/MI† Death† MI RI 0.6 0.8 1 1.2 Hazard ratio (95% CI) *P = 0.06†P = 0.05 OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  17. OASIS-5: Summary At 9 days • Primary outcome (death, MI, refractory ischemia) Fondaparinux was similar to enoxaparin in reducing the risk of ischemic events • Primary safety outcome Rate of major bleeding was significantly lower for fondaparinux vs enoxaparin • Benefit/risk assessment Rate of combined death, MI, refractory ischemia, and major bleeding was significantly lower for fondaparinux vs enoxaparin OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

  18. OASIS-5: Summary, cont’d • Overall, durable long-term results were observed with fondaparinux vs enoxaparin; results occurred early and remained consistent through study end • Strong trend toward lower rate of death, MI, or refractory ischemia at 30 days (P = 0.13) through 6 months (P = 0.06) • Net clinical benefit in favor of fondaparinux at 6 months was demonstrated by significantly lower rate of combined death, MI, refractory ischemia, major bleeding (P < 0.001) OASIS-5 Investigators. N Engl J Med. 2006;354:1464-76.

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