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Organization for the Assessment of Strategies for Ischemic Syndromes 6 (OASIS-6) Trial

OASIS - 6 Trial. Organization for the Assessment of Strategies for Ischemic Syndromes 6 (OASIS-6) Trial. Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Salim Yusuf. OASIS - 6 Trial: Background.

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Organization for the Assessment of Strategies for Ischemic Syndromes 6 (OASIS-6) Trial

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  1. OASIS - 6 Trial Organization for the Assessment of Strategies for Ischemic Syndromes 6 (OASIS-6) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Salim Yusuf

  2. OASIS - 6 Trial: Background • The goal of the trial was to evaluate treatment with fondaparinux compared with control (unfractionated heparin or placebo) among patients with STEMI. • Patients were separated into Stratum 1 (control group inelligible for UFH treatment, in other words fondaparinux was compared to placebo) and Stratum 2 (active control group was UFH) • Also, there was a PCI substudy that assessed the efficacy of fondaparinux in Stratum 1 and Stratum 2 in the primary PCI setting. Presented at ACC 2006

  3. OASIS – 6 Trial: Study Design 12,092 patients presenting with STEMI within 24 hours of symptom onset (shortened to 12 hours of symptom onset midway through trial) Randomized. Blinded. Factorial. 28% female, mean age 62 years, mean follow-up 3-6 months Stratum 2 (UFH) Stratum 1 (No UFH) UFH Fondaparinux 2.5mg/day for up to 8 days or hospital discharge Fondaparinux 2.5mg/day for up to 8 days or hospital discharge Placebo • Primary Endpoint: Composite of death or reinfarction at 30 days • Secondary Endpoint: Composite of death or reinfarction at 9 days and at final follow-up Presented at ACC2006

  4. OASIS – 6 Trial: Primary Endpoint Primary Endpoint: Death/Reinfarction (%) • The primary endpoint was lower in the fondaparinux group compared with the control group (9.7% vs.11.2%, HR 0.86, p=0.008) • The results were similar at 9 days (HR 0.83, p=0.003) and at study end (HR 0.88, p=0.008) Frequency p=0.008 p=0.008 p=0.003 Presented at ACC 2006

  5. OASIS – 6 Trial: Primary Endpoint (cont.) Reduction in Death/MI: Stratum 1 (No UFH indicated) p<0.05 Reduction in Death/MI: Stratum 2 (UFH Indicated) p=NS p=0.97 • The reduction in the primary endpoint at 30 days in the Fondaparinux group was driven by Stratum 1, where death/MI occurred less frequently among Fonda pts than Placebo (11.2 vs. 14%, HR 0.79, p<0.05) • There was no difference in Stratum 2, comparing those patients who received Fondaparinux vs those who received UFH (8.3% vs. 8.7%, HR 0.96, p=NS) Presented at ACC 2006

  6. OASIS – 6 Trial: Primary Composite Endpoint Components of Primary Composite Endpoint (%) • Among the components of the composite at 30 days, mortality was lower in the fondaparinux group compared to the control group (7.8% vs. 8.9%, HR 0.87, p=0.03). • Reinfarction was also lower in the fondaparinux group compared to the control group (2.5% vs. 3.0% HR 0.81, p=0.06). p=0.03 p=0.06 Presented at ACC 2006

  7. OASIS - 6 Trial: PCI Substudy at 30 Days Primary Endpoint of Death or MI in PCI Cohort (%) p=0.19 • There was no difference in the primary endpoint for patients who were managed with primary PCI (6.1% vs 5.1%, p=0.19). • Guiding catheter thrombosis in the primary PCI cohort occurred more often with fondaparinux compared with control (n=22 vs. n=0, p<0.001) Presented at ACC 2006

  8. OASIS - 6 Trial: PCI Substudy (cont.) Severe Bleeding at 9 days (%) p=NS • There was no difference in severe bleeding at 9 days by treatment group • (1.0% Fondaparinux vs. 1.3% control, p=NS) • Intracranial hemorrhage occurred in 0.2% in each group Presented at ACC 2006

  9. OASIS - 6 Trial: PCI Substudy (cont.) Guiding Catheter Thrombosis p<0.001 • There was a higher instance of guiding catheter thrombosis in the PCI cohort treated with fondaparinux compared to control (n=22 vs. n=0, p<0.001) Presented at ACC 2006

  10. OASIS - 6 Trial: PCI Substudy (cont.) Coronary Complications p=0.04 • Coronary complications occurred in more patients treated with fondaparinux compared to control (n=270 vs. n=225, p=0.04) • Coronary complications include abrupt closure, no reflow, dissection, new angiographic thrombus, perforation, or catheter thrombus Presented at ACC 2006

  11. OASIS – 6 Trial: Conclusions • The benefit of Fondaparinux was confined to patients in Stratum 1 where placebo or no antithrombin was administered • Fondaparinux was not superior to active control UFH • Fondaparinux was associated with a hazard in those patients who underwent PCI including guiding catheter thrombosis Presented at ACC 2006

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