(This was originally a secondary outcome, but they changed it to a primary outcome). The percent change from baseline in anti–factor Xa activity.Exclusions: Surgery planned within 12 hours, intracranial hemorrhage with a GCS less than 7 or an estimated hematoma size of 60 mL, expected survival less than 1 month, a thrombotic event in the last 2 weeks, or any of the following in the prior 7 days: vitamin K antagonist, dabigatran, prothrombin complex concentrate, recombinant factor VIIa, whole blood, or plasma.īolus of andexanet alfa followed by a 2 hour infusion.Major bleeding was defined as signs of hemodynamic compromise, or a hemoglobin drop of 2 g/dL (20g/L), or any hemoglobin blow 8 g/dL (80 g/L), or bleeding in a critical area (retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome).PatientsĪdult patients with major bleeding who had taken one of apixaban, rivaroxaban, or edoxaban at any dose or enoxaparin at a dose of at least 1 mg per kilogram per day within the last 18 hours. This is a multicenter, prospective, open-label, single-group study. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors. This paper is another bit of advertising disguised as (completely unusable) science in the increasingly horrible New England Journal of Medicine.Ĭonnolly SJ, Crowther M, Eikelboom JW, et al.

Because the activity of uncontrolled observation certainly fits into a broader definition of science, I will refine my terminology and say instead that this is not usable science).

(At that time, I was chastised by Scott Weingart for saying “this is not science”. This decision is almost identical to the approval of idarucizumab, a debacle I have discussed previously. Last year, the FDA granted andexanet alfa an accelerated approval as a reversal agent for factor Xa inhibitors, but based that decision on a complete lack of useable science.