Prothrombin complex concentrate for oral factor Xa inhibitor-associated intracerebral hemorrhage

Background: Factor Xa inhibitor-associated intracerebral hemorrhage (ICH) requires rapid anticoagulation reversal. Although andexanet alfa, a specific FXaI antidote, demonstrated efficacy in andexenet alfa for acute intracerebral hemorrhage (ANNEXA-I) trial, it was associated with a high thromboembolic rate. Consequently, 4-factor prothrombin complex concentrate (4F-PCC) is widely used, though real-world data remain limited. Objective: To assess the hemostatic effectiveness and safety of 4F-PCC for reversal of oral factor Xa inhibitors in patients with acute intracerebral hemorrhage. Methods: We conducted a single-center, retrospective observational study of consecutive patients with FXaI-associated ICH treated with 4F-PCC between January 2017 and May 2025. The primary endpoint was hemostatic efficacy according to ANNEXA-I criteria: hematoma expansion < 35%, National Institutes of Health Stroke Scale (NIHSS) score increase of