From the Guidelines
Prothrombin Complex Concentrate (PCC) is not recommended as a reversal agent for Rivaroxaban-induced bleeding.
Rationale
- The evidence from multiple studies 1 suggests that PCC does not effectively reverse the anticoagulant effects of Rivaroxaban.
- Specifically, studies have shown that PCC does not correct the prothrombin time (PT) or anti-Xa activity in patients taking Rivaroxaban 1.
- Additionally, PCC has not been shown to reduce bleeding in clinical studies, and its use is not supported by controlled clinical trials 1.
- The dose of PCC used in these studies varied, but 50 IU kg-1 was the most commonly used dose, and it did not demonstrate a significant reversal effect 1.
- In clinical practice, caution should be exercised when considering the use of PCC as a reversal agent for Rivaroxaban-induced bleeding, and alternative treatments such as supportive care and transfusions should be considered instead.
- It is essential to note that there is no established dose of PCC that has been proven to be effective in reversing Rivaroxaban-induced bleeding, and its use should be approached with caution.
- Further research is needed to determine the safety and efficacy of PCC as a reversal agent for Rivaroxaban-induced bleeding.
From the Research
Role of Prothrombin Complex Concentrate (PCC) in Managing Bleeding Induced by Rivaroxaban
- PCC can be used to reverse the anticoagulant effects of rivaroxaban in patients with major bleeding 2, 3, 4, 5, 6
- The dose of PCC used in these studies varied, with doses ranging from 25 U/kg to 50 IU/kg 2, 5
Efficacy of PCC in Reversing Rivaroxaban-Induced Anticoagulation
- PCC has been shown to improve thrombin generation and prothrombin time in patients with bleeding complications related to rivaroxaban 5
- PCC can partially reverse the anticoagulant effects of rivaroxaban, with a maximal effect of approximately 50% 6
- The efficacy of PCC in reversing rivaroxaban-induced anticoagulation may depend on the parameter measured, with endogenous thrombin potential (ETP) measurements potentially having predictive power for assessing the reversal potential of PCC 6
Clinical Outcomes with PCC Use in Rivaroxaban-Associated Bleeding
- Clinical hemostasis was achieved in 68.6% to 72.4% of patients with major bleeding associated with rivaroxaban who were treated with PCC 3, 4
- PCC may be an alternative to specific antidotes, such as andexanet alfa, for patients who need anticoagulation reversal 3, 4
- The safety of PCC in this setting appears to be acceptable, with no significant increase in thromboembolic events reported 3, 4, 5