Safety of Prothrombin Complex Concentrate for Emergency Surgery According to the Oral Factor Xa Inhibitor Level

Area of Science:

• Pharmacology
• Hematology
• Critical Care Medicine

Background:

• Anti-Xa assays are often unavailable, leading to empirical 4-factor prothrombin complex concentrate (4F-PCC) use in patients on factor Xa inhibitors (XaI).
• Urgent clinical decisions regarding 4F-PCC administration are frequently made without rapid measurement of XaI levels.

Purpose of the Study:

• To investigate whether thrombotic risk is elevated in patients on XaI who receive 4F-PCC when preoperative XaI levels are low or unmeasured.
• To inform clinical practice in settings lacking rapid anti-Xa testing capabilities.

Main Methods:

• Retrospective analysis of 227 patients receiving 4F-PCC for emergency surgery/procedures across five hospitals.
• Assessment of symptomatic or asymptomatic thromboembolism within 7 days and between postoperative days 8-30 post-infusion.
• XaI levels determined via anti-Xa assay, calibrated to the patient's specific anticoagulant (apixaban, rivaroxaban, or edoxaban).

Main Results:

• Thromboembolism within 7 days occurred in 3% of patients with high XaI levels, 0% with low levels, and 5% with unmeasured levels.
• Median 4F-PCC dose was 2000 units; 94% of patients received prompt venous thromboembolism prophylaxis.
• No significant difference in thromboembolic events was observed across groups based on preoperative XaI level status.

Conclusions:

• The risk of thromboembolism after 4F-PCC administration in XaI patients undergoing emergency procedures appears consistent, irrespective of preoperative XaI levels (high, low, or unmeasured).
• Findings support the empirical use of 4F-PCC in urgent situations where rapid anti-Xa assay results are not immediately available.