Prothrombin complex concentrate for oral factor Xa inhibitor reversal prior to urgent invasive procedures.

BACKGROUND

Oral factor Xa (FXa) inhibitors are anticoagulants with no approved reversal agent for use before urgent invasive procedures. Four-factor prothrombin complex concentrate (4F-PCC) is used off-label for this despite limited evidence regarding its effectiveness and safety.

AIMS: To determine the efficacy of 4F-PCC prior to urgent invasive procedures in FXa inhibitor-treated patients. Secondary aims were hemoglobin levels and transfusion requirements within 48 h following the procedure, to determine the effect of treatment on anti-FXa levels and to document thromboembolic events and mortality at 30 days.

METHODS

We conducted a prospective, single-center observational study of consecutive adults receiving 4F-PCC for reversal of oral FXa inhibitors before urgent invasive procedures with moderate-to-high bleeding risk.

RESULTS

Fifty-nine were included in the analysis (median age 78 years). Apixaban was the most frequently used anticoagulant (83.1%). 74.6% underwent urgent surgical procedures and 25.4% underwent other invasive procedures. The median 4F-PCC dose was 2000 units. The primary endpoint of normal or mildly abnormal hemostasis was achieved in 89.8% of patients (84.7% normal, 5.1% mildly abnormal). About 10.2% had moderately abnormal hemostasis; no patients had severe hemostatic failure. Median hemoglobin decline was 1.5 g/dL, with 8.5% of patients requiring red blood cell transfusion. In 17 patients with paired measurements, median decrease in anti-FXa activity was 42%. Thromboembolic events occurred in 5.1%, and 30-day mortality was 10.2%.

CONCLUSIONS

Thromboembolic events were infrequent. These data support the use of 4F-PCC for reversal of FXa inhibitors prior to urgent invasive procedures with a moderate or high bleeding risk.