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Methods: This retrospective study included all patients with major bleeding that received andexanet for factor Xa inhibitor reversal. An equivalent number of historical patients that were administered PCC were randomly selected as comparators. Only patients that presented prior to the approval date of andexanet were included in the PCC group. The primary outcome was the percentage of patients that achieved effective hemostasis 12 hours after andexanet or PCC administration. Definitions for hemostasis were adopted from the ANNEXA-4 trial. Safety outcomes assessed were the incidence of thromboembolic events and mortality within 30 days.

Results: A total of 32 patients were included: 16 received andexanet and 16 received PCC. Baseline characteristics were not statistically different. Median age 69, average ICU length of stay 9 days, and common past medical histories included heart failure (25% vs 38 …