Fixed‐dose three‐factor prothrombin complex concentrates is safe and effective in warfarin reversal

BACKGROUND: Reversal of warfarin with prothrombin complex concentrates (PCC) is required in cases of significant bleeding or need for urgent surgery. A weight-based regimen is commonly, but a fixed-dose approach is also feasible with clinically equivalent outcomes. The purpose of this audit is to review the clinical and laboratory outcomes of patients treated in our centre where fixed-dose PCC is used for warfarin reversal. AIMS: The primary objective was to evaluate the post-reversal international normalised ratio (INR). The secondary objectives were the proportion of patients requiring repeat PCC and 30-day complication rates (death, haemorrhage and thrombosis). A subgroup analysis was also performed to compare the outcomes of those who received a dose of ≤15 IU/kg (reduced dose) with those who received >15 IU/kg (standard dose). METHODS: Patients who received three-factor PCC for warfarin reversal between 1 January and 31 December 2016 were identified and analysed. Clinical data and PCC dosages were extracted from electronic patient records. RESULTS: A total of 144 patients were analysed. The median INR pre-reversal was 3.25 (range 1.4-10), which reduced to 1.5 (0.9-3.0) post-reversal. Eighty-seven percent of patients achieved a post-reversal INR of less than 2 and 55% less than 1.5. Sixteen patients required a repeat dose. Complications occurred in 22 (15.3%) patients, which consisted of 15 deaths, 7 thrombosis and 2 haemorrhage. No statistically significant differences in the primary and secondary outcomes were noted between reduced-dose and standard-dose subgroups. CONCLUSION: Our results support the use of fixed-dose PCC for warfarin reversal in a day-to-day clinical practice in a hospital setting.