As you know, coagulopathy — common in trauma and perioperative bleeding — must be addressed. When this situation presents, increased morbidity and mortality result, and “anticoagulation can further increase a patient’s risk of developing coagulopathic bleeding.” Is four-factor prothrombin complex concentrate (PCC) the answer? Can it help anesthesiologists better manage patients who are receiving direct oral anticoagulants?
Direct Oral Anticoagulants / Factor X Inhibitor Therapies
Direct oral anticoagulants (DOACs), or factor X inhibitor therapies, have been approved by the FDA since 2010. Data (and evidence) for managing patients on DOACs is still in the early stages. However, some of the benefits of DOACs include:
- More predictable pharmacokinetics and pharmacodynamics
- Fewer interactions with other medications and food
- Not associated with the problems of a narrow therapeutic window (like warfarin)
- Favorable safety and efficacy profiles (demonstrated in “real-world” cohorts)
- Allowing for fixed dosing one to two times per day
- Elimination of anticoagulation monitoring
- Elimination of dose adjustments
Once your patients are on DOACs, you must have a game plan for preventing coagulopathy. Recent literature has concluded:
“There is reason to believe that the use of 25 IU/kg PCC for management of activated factor X inhibitor-associated bleeding has a positive effect without significantly increasing the risk of thromboembolic events.”
Four-Factor PCC Is a More Effective (and Cheaper) Alternative
In the United States, “four-factor PCC was only approved in 2013 and is currently restricted in use to the urgent reversal of vitamin K antagonist therapy.” While we are still lacking fully conclusive data from randomized controlled trials, in clinical trials so far, for the reversal of activated factor X inhibitors, PCC compares favorably to andexanet alfa in terms of cost, effectiveness and a low level of thromboembolic complications:
“Current data including recent results from the UPRATE study support the use of PCC for the reversal of activated factor X inhibitors in bleeding patients and suggest that PCC could become a useful and relatively affordable option for management of DOAC-associated bleeding. Further studies are needed to investigate the optimal dosing of PCC to maintain the balance between procoagulant effectiveness and low thrombotic risk.”
It is predicted that the number of patients using DOACs will likely increase in the near future due to their advantages over existing therapies. However, the downside is: The number of bleeding events in patients on DOAC therapy is also expected to increase. Given that, ensure that you have a clear strategy for anticoagulation reversal and a game plan for achieving hemostasis; you may also want to consider administering PCCs for patients on DOACs.