Prothrombin Complex Concentrate before Urgent Surgery in Patients Treated with Rivaroxaban and Apixaban

Abstract

Introduction: Patients treated with direct Xa inhibitors may require urgent surgery. Administration of prothrombin complex concentrate (PCC) in this setting is common; however, it is based on limited experience in healthy volunteers. Objective: To characterize the population receiving PCC for apixaban/rivaroxaban reversal prior to an urgent surgery and evaluate its efficacy and safety. Methods: This was a retrospective study in 2 tertiary hospitals. Bleeding was evaluated based on surgical reports, hemoglobin drop, and the use of blood products or additional PCC during 48 h. Safety measures were thrombotic complications and 30-day mortality. Results: Sixty-two patients aged 80.7 ± 9 years, treated with apixaban (39.63%) or rivaroxaban (23.37%), received PCC before an urgent surgery/procedure. Most underwent abdominal operation (61%), orthopedic surgery (13%), or transhepatic cholecystostomy insertion (10%). Bleeding during surgery was reported in 3 patients (5%), no patient required additional PCC, and 16 patients (26%) received packed cells (median: 1 unit, range: 1–5). The 30-day mortality and thrombosis rates were 21% (n = 13) and 3% (n = 2), respectively. The cause of death was related to the primary disease, most commonly sepsis. No patient died due to bleeding/thrombosis. Conclusions: Our results support the use of PCC to achieve hemostasis in patients treated with Xa inhibitors prior to an urgent surgery.

Emergencies on direct oral anticoagulants: Management, outcomes, and laboratory effects of prothrombin complex concentrate

“…Our observed surgical effective hemostasis rate after treatment with PCC is high and similar to the rate observed in an Israeli retrospective study in which they included more severe urgent interventions than we did in our cohort 32 . Thromboembolic and mortality rates at 30 days are similar.…”

“…However, when making this indirect comparison, it needs to be kept in mind that for both cohorts different definitions for the primary outcome effective hemostasis were applied. 32 Of interest, in spite of similar effective hemostasis and thromboembolism, the median administered dose of PCC in our cohort was twice as high (50 vs. 25 IU/kg) than in the other 2 cohorts reporting effective hemostasis. 21,22 This raises important questions on the optimal PCC dose.…”

“…13,23,31 Our observed surgical effective hemostasis rate after treatment with PCC is high and similar to the rate observed in an Israeli retrospective study in which they included more severe urgent interventions than we did in our cohort. 32 Thromboembolic and mortality rates at 30 days are similar. However, when making this indirect comparison, it needs to be kept in mind that for both cohorts different definitions for the primary outcome effective hemostasis were applied.…”

“…Thromboembolic and mortality rates at 30 days are similar. However, when making this indirect comparison, it needs to be kept in mind that for both cohorts different definitions for the primary outcome effective hemostasis were applied 32 …”

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

“…Other agents that have been used for DOAC reversal include three-or four-factor prothrombin complex concentrates (PCCs) or activated PCCs. [89][90][91][92][93][94] These non-specific reversal agents are expected to have an impact on coagulation screening tests but not on anti-Xa-or anti-IIa-based assays, but data are currently limited with DOAC reversal strategies. The amount of PCC needed to stop DOAC-induced bleeding may depend on the residual DOAC concentration at the time PCC is administered.…”