PROXY Trial

PCC for emergency surgery in patients on oral FXa inhibitors

Patients with atrial fibrillation on oral anticoagulants often need temporary discontinuation for surgery. Limited data exist on reversing FXa inhibitors (FXaI) before urgent procedures, with Prothrombin Complex Concentrate (PCC) commonly used despite unclear efficacy and safety [1–8].

Prothrombin complex concentrate for emergency surgery in patients on oral Xa-inhibitors

This was a prospective cohort study, performed in 3 centers in Canada, evaluating whether a fixed PCC dose prevents bleeding in patients with FXaI levels ≥75 ng/mL undergoing urgent surgery without increasing thrombotic risk.

Andexanet alfa was unavailable in Canada, and participating sites adhered to hospital protocols recommending PCC for FXaI reversal in patients who experienced serious bleeding or required emergency surgery.

Eligible patients were adults aged ≥18 years, receiving apixaban, rivaroxaban, or edoxaban, and in need of surgery or an invasive procedure that could not be delayed for ≥8 hours. These procedures required normal hemostasis due to an expected blood loss of ≥50 mL.

Exclusion criteria included refusal to provide informed consent and surgeries or invasive procedures that could safely proceed without discontinuing anticoagulant therapy, such as dermatologic procedures, certain biopsies, or injections.