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OASIS-6 TRIAL |
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| Problem | ACS (STEMI) |
| Format | 0 |
| Treatment | Fondaparinux 2.5mg daily |
| Control | UFH or Placebo |
| Population | 12,092 patients |
| Inclusion criteria | fter obtaining written informed consent, patients presenting with STEMI within 24 hours of symptom onset were enrolled. This time window was shortened to less than 12 hours after approximately 4300 patients had been enrolled, based on the results of the CREATE trial. |
| Exclusion criteria | Patients with contraindications to anticoagulation, including those at high risk of bleeding, receiving oral anticoagulants, or with creatinine levels greater than 265.2 mg/dL (3.0 mmol/L), were excluded. |
| Follow-up | 6 months |
| Primary endpoint | Composite of death or reinfarction at 30 days |
| Secondary endpoint(s) | Composite of death or reinfarction at 9 days and at final follow-up |
| Details | Randomization was stratified by indication for the use of UFH based on the investigator's judgment. Five thousand six hundred fifty-eight patients were enrolled in stratum 1 (no indication for UFH) and 6434 patients were enrolled in stratum 2 (indication for UFH, eg, intended use of fibrin-specific thrombolytic, patients not eligible for fibrinolytics but eligible for antithrombotics, or those scheduled for primary PCI). From the paper: \Patients were also randomly assigned to receive an infusion of glucose-insulin-potassium (GIK) or no infusion in a partial factorial design to evaluate its effects in preventing death or nonfatal cardiac arrest. This part of the study was discontinued in November 2004 after the results of the CREATE-ECLA (Estudios Cardiologicas Latin America) GIK study indicated that GIK was not beneficial.14 At that time |
| Brief summary: | Fondaparinux in STEMI better than UFH in those not for PCI, but not suitable without UFH in PCI |
| PAPER: Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. | |
|---|---|
| Date | 5 Apr 2006 |
| Journal | JAMA. 2006 Apr 5;295(13):1519-30. |
| Information | Complex trial with 2 strata: 1) No indication for UFH -> Fondaparinux vs. placebo - Significant benefit in death/reinfarction for those receiving fondaparinux 2 - Patients where UFH indicated -> Fondaparinux vs. UFH a) Those not undergoing PCI - Significant benefit in death/reinfiarction @ 30d with fondaparinux b) Those undergoing PCI - No benefit, trend towards increased death/reinfarction with fondaparinux - Significant increase in catheter thrombosis (see OASIS-5) Trend towards less bleeding with fondaparinux (see OASIS-5) - N.B. Was strongest in placebo group (?) |