4F-PCC effective in reversal of FXa inhibitor-related acute major bleeding

Use of a 4-factor prothrombin complex concentrate (4F-PCC) for oral factor Xa (FXa) inhibitor-related acute major bleeding appears to work for most patients, results of a recent study have shown.

“In cases of oral FXa inhibitor-associated acute major bleeding, several reversal strategies are available,” the authors said. “Current guidelines recommend a dose of 50 U/kg if using 4F-PCC.”

This retrospective case series described the utilization of 4F-PCC for the reversal of oral FXa inhibitor-related acute major bleeding among admitted patients aged ≥18 years who received the study drug.

The authors defined major bleeding using the International Society of Thrombosis and Hemostasis definition for major bleeding in nonsurgical patients. The achievement of haemostasis was the primary outcome.

Thirty-one patients were eligible for analysis, of whom 17 received rivaroxaban and 14 apixaban. The most common type of bleeding was intracranial haemorrhage, which occurred in 15 patients (55 percent). The median dose of 4F-PCC was 37 U/kg.

Of note, majority of the patients (68 percent) evaluated in the primary endpoint analysis achieved effective haemostasis, while four (12.9 percent) had a documented thrombotic event within 7 days of receiving 4F-PCC.

“The rate of thrombotic events appears higher compared to previously published studies, although major confounders exist and larger studies are needed to fully evaluate the safety of 4F-PCC for this indication,” the authors noted.