Optimal management of major bleeding on DOACs: not only reversal agents

Excerpt

Direct oral anticoagulants (DOACs) are currently prescribed in more than 50% of patients affected by non-valvular atrial fibrillation (FANV) or venous thromboembolism [1, 2]. Data from post-marketing studies confirmed the favourable risk–benefit profile of DOACs when compared with vitamin K antagonist (VKA) [3, 4]. However, all anticoagulant drugs carry an intrinsic unavoidable bleeding risk. Although rare, major and life-threatening bleedings required a timely management, given their high case-fatality rate and potential morbidity. Well-defined and widely available management protocols are crucial to address these emergency situations without delay. The development of a first reversal agent, e.g., idarucizumab, opened the new era of DOAC-specific antidote to restore haemostasis on time. As Andexanet alpha is not licensed in many countries, factor Xa inhibitors’ reversal can be rapidly managed by bypass-agents, mainly prothrombin complex concentrate (PCC) [5]. Despite four-factor PCC being off-label for DOACs’ reversal, it is recommended by several experts as the first-line measure to immediately restore haemostasis in absence of specific DOACs antidote [6]. Presently, data available about DOAC reversal by PCC derive from animal models, in vitro and ex vivo observational studies on healthy volunteers. However, a placebo-controlled study or a study with a comparator arm to investigate four-factor PCC efficacy and safety in bleeding patients with DOACs on board will be unlikely to be performed. Hence, in this scant background, data about four-factor PCC effectiveness derived from real-life studies represent a valuable knowledge contribution. In this journal, Sheikh-Taha provides informative data about current management procedures to accomplish apixaban or rivaroxaban reversal in 29 real-life patients who experienced major bleeding [7]. Clinical scenario was well detailed. Major bleedings were defined according to the ISTH definition [8], and all patients had taken their last DOAC dose within 24 h from hospital admission. …