ArticleResearch and practice in thrombosis and haemostasis2026
Prothrombin complex concentrate for oral factor Xa inhibitor-associated intracerebral hemorrhage.
Article in Research and practice in thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
- The long road back to the start: a return to prothrombin complex concentrate.Research and practice in thrombosis and haemostasis · 2026Article
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11 authors.
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No grant is acknowledged in the PubMed record.
Abstract
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 <7 points, and absence of rescue therapy within 12 hours. The secondary endpoint was a stable neurological status (no worsening of the NIHSS score) at 48 hours. Safety outcomes included 30-day thromboembolic events and mortality. Results: Fifty-two patients (median age, 81 years; IQR, 75-87; 61.5% male) were included. Apixaban was the most frequent FXaI (86.6%), with atrial fibrillation as the main indication (94.3%). The median baseline hematoma volume was 5.45 mL (IQR, 2-21), and the NIHSS score was 4.5 (IQR, 1-6). The primary endpoint was achieved in 39 patients (75.0%; 95% CI, 61.1%-86.0%). Stable neurological status at 48 hours occurred in 37 patients (71.2%; 95% CI, 56.9%-82.9%). One thromboembolic event (deep vein thrombosis) occurred (1.9%; 95% CI, 0.0%-10.3%), and 12 patients (23.1%; 95% CI, 12.5%-36.8%) died within 30 days. Conclusion: 4F-PCC achieved high hemostatic efficacy and low thromboembolic risk in FXaI-associated ICH. Mortality was comparable to ANNEXA-I, but thrombotic events were markedly lower, supporting current guideline recommendations for 4F-PCC use in this setting.
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