1 / 18

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.

rebeccahernandez
Download Presentation

OASIS-5

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related