First, the study was funded, designed and supervised by Portola Pharmaceuticals, the maker of Andexanet alfa. There were several limitations of this study that bear mentioning. In terms of safety outcomes, death within 30 days occurred in 49 patients (14%) and thrombotic events occurred in 34 patients (10%).
At four, eight and 12 hours, patients on Apixaban had a median anti-factor Xa activity reduced from baseling by 32%, 34%, and 38% respectively, while patients on Rivaroxaban had a median anti-factor Xa activity reduction from baseline of 42%, 48%, and 62% respectively. The 134 patients on Apixaban and 100 patients on Rivaroxaban had a 92% reduction in their anti-factor Xa level. Safety outcomes included death, thrombotic events, and development of antibodies to andexanet or to native factor X and factor Xa.Ī total of 352 patients were evaluated (227 patients, or 64%, had intracranial hemorrhage and 90 patients, or 26%, had gastrointestinal bleeding). The co-primary outcomes were: Percent change in anti-factor Xa activity after Andexanet treatment and percentage of patients with excellent or good hemostatic control at 12 hours after completion of Andexanet alfa infusion. retroperitoneal, intra-articular, pericardial, epidural, or intracranial bleeding, or intramuscular bleeding with compartment syndrome) Bleeding in a critical area or organ (i.e.Bleeding associated with a decrease in hemoglobin level of at least 2g/dL (or a Hb ≤8g/dL if no baseline hemoglobin).severe hypotension, poor skin perfusion, confusion, or low cardiac output that could not otherwise be explained) Potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise (i.e.Acute major bleeding was defined as having one or more of the following features:
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