Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

This retrospective study investigated the efficacy and safety of prothrombin complex concentrates (PCCs) for management of major bleeding events (MBE) in 344 patients receiving the anticoagulants rivaroxaban, apixaban or warfarin during the period January 2016 to April 2018. Median (range) PCC dose was 2000 units (1000-4500). Intracranial haemorrhage (ICH) was the most common indication (137/344, 39 center dot 8%) for PCC use followed by gastrointestinal bleeding (93/344, 27%). ICH patients more frequently received rivaroxaban (62 center dot 5%) or apixaban (52 center dot 5%) compared to warfarin (34 center dot 5%), P = 0 center dot 002; and visceral bleeding patients received warfarin more frequently (24 center dot 2%) than rivaroxaban (5%) or apixaban (10%), P = 0 center dot 003. Median rivaroxaban and apixaban levels were 230 ng/ml (47-759) and 159 ng/ml (45-255). Median International Normalised Ratio pre- and post-PCC in patients on warfarin were 3 center dot 4 (1 center dot 9-15 center dot 4) and 1 center dot 2 (1 center dot 0-1 center dot 9). Blood products use was the same between groups. Thirty-day mortality and re-bleeding rates in patients with ICH were 35% (P = 0 center dot 50) and 18% (P = 0 center dot 90) with no differences between the groups. Thrombosis occurred in 4 center dot 1% patients within 30 days with no difference between groups. Two of 91 (2 center dot 2%) patients with ICH only (both on warfarin) had ischaemic strokes within 30 days post-PCC. In conclusion, there was no difference in the safety (thrombosis) or efficacy (30-day mortality, re-bleeding) in use of PCC for MBE in patients on warfarin, rivaroxaban or apixaban.