Use of 4F-PCC safe, effective in factor Xa inhibitor-related bleedings

Treatment with four-factor prothrombin complex concentrate (4F-PCC) appears safe and effective for patients with factor Xa inhibitor-associated bleeding events, suggests a recent study.

A team of investigators conducted an observational, retrospective review of 4F-PCC use to assess its safety and efficacy in the management of factor Xa inhibitor-related bleeds. The study was carried out from May 2014 to December 2018 at a single health system.

Efficacy was assessed using the criteria described by Sarode and colleagues. Secondary endpoints included thromboembolic events, length of stay, mortality, and discharge disposition.

Of the 59 patient charts reviewed, 48 were included in the analysis. Use of 4F-PCC resulted in effective haemostasis in 33 patients (68 percent), as well as in 12 patients (86 percent) who had intracranial haemorrhage and did not receive any surgical intervention.

In terms of safety, four patients experienced thromboembolic events within 30 days from 4F-PCC use. Most of the patients (85.4 percent) were discharged from the hospital to home or long-term care, but seven (14.6 percent) died in the hospital.

“The recent approved agent for factor Xa inhibitor reversal, andexanet alfa, has limited clinical efficacy and safety data, and it can be a financial burden on healthcare systems due to its high cost,” the investigators said. “4F-PCC has been utilized off label in patients with factor Xa inhibitor-related bleedings.”