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The impact of prothrombin complex concentrates when treating DOAC-associated bleeding: a review.

ABSTRACT: BACKGROUND:Bleeding complications are a risk associated with all anticoagulants. Currently, the treatment options for the management of direct oral anticoagulant (DOAC)-associated bleeding are limited. Prothrombin complex concentrates (PCCs) have been proposed as a potential therapeutic option, and evidence regarding their use is increasing. REVIEW:Many studies supporting PCC have used preclinical models and healthy volunteers; however, more recently, observational studies have further improved insight into current DOAC reversal strategies. Multiple clinical practice guidelines now specifically suggest use of PCCs for this indication. Specific reversal agents for Factor Xa inhibitors may become available in the near future, but data on their efficacy are still emerging. CONCLUSIONS:Ultimately, a multimodal approach may be the optimal strategy to restore haemostasis in patients presenting with DOAC-associated coagulopathy.

SUBMITTER: Hoffman M

PROVIDER: S-EPMC6326120 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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The impact of prothrombin complex concentrates when treating DOAC-associated bleeding: a review.

Hoffman Maureane M Goldstein Joshua N JN Levy Jerrold H JH

International journal of emergency medicine 20181203 1

<h4>Background</h4>Bleeding complications are a risk associated with all anticoagulants. Currently, the treatment options for the management of direct oral anticoagulant (DOAC)-associated bleeding are limited. Prothrombin complex concentrates (PCCs) have been proposed as a potential therapeutic option, and evidence regarding their use is increasing.<h4>Review</h4>Many studies supporting PCC have used preclinical models and healthy volunteers; however, more recently, observational studies have fu ...[more]

PMID: 31179943

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Project description:Background: Mortality of oral anticoagulation-associated ICH is around 60%, with oral anticoagulation increasing the risk of ICH seven to ten-fold compared to no anticoagulation. Current guidelines recommend DOACs (direct oral anticoagulants) as first-line therapy in the treatment of VTE (Venous Thromboembolism) due to their more favorable safety profile. There are two agents available for DOAC reversal, Coagulation Factor Xa (recombinant), inactivated-zhzo (andexanet alfa, Andexxa®) and 4-factor prothrombin complex concentrate (4FPCC). There is little data comparing the two agents in real-life clinical settings.ObjectiveThe primary objective of this study was to determine if there was a difference in hemostatic efficacy of andexanet alfa and 4FPCC in patients with a factor Xa inhibitor-related intracranial hemorrhage.MethodsThis was a retrospective, single-center study conducted in adult patients admitted at a quaternary academic medical center from September 2017 to March 2021. Adults with a diagnosis of intracranial hemorrhage (ICH) were included if they received either 4FPCC or andexanet alfa for reversal of apixaban or rivaroxaban. In addition to hemostatic efficacy per imaging, we assessed disposition location, cerebral performance score, blood product consumption, and the development of a new thrombus.ResultsA total of 46 patients were included in this study, 15 received 4FPCC (32%) and 31 received andexanet alfa (68%). There was no difference in the proportion of patients with excellent (4FPCC 9 [60%] vs. andexanet alfa 16 [51.6%], p = 0.61), good (4FPCC 2 [13.3%] vs. andexanet alfa 7 [22.6%]), or poor (4FPCC 1 [6.7%] vs. andexanet alfa 5 [16.1%]) hemostasis after administration of each agent. There were no significant differences in any secondary outcomes.Conclusion and relevanceOur study found no difference in hemostatic efficacy between andexanet alfa and 4FPCC. At this time, clinicians should choose an agent based on individual patient presentation and resource availability. Further research will help clarify the role of each agent in the management of DOAC-related intracranial hemorrhage.

Project description:Patients with liver disease frequently develop coagulopathy, and fresh frozen plasma is traditionally used for correction of coagulopathy to manage and prevent bleeding. Prothrombin complex concentrates (PCCs) offer an attractive alternative because they are more readily available and avoid large-volume transfusion. This retrospective, single-center study reviewed clinical use of PCC in patients with acute/chronic liver disease. A total of 105 patients with 194 episodes of PCC administration were reviewed. Data pertaining to indication, dosing, effectiveness, and safety were collected. The effect of PCC on coagulation was analyzed in patients for whom coagulation results were available 7 hours before and after PCC. Data on thromboembolic events and mortality within 4 weeks of PCC administration were captured. Most patients (77%) had chronic liver disease; the remainder had acute liver failure. Indications for PCC were preprocedure prophylaxis and treatment for active/recent bleeding in 48% and 52% of 194 treatment episodes, respectively. The median dose of PCC administered was 22 IU/kg (interquartile range, 16-29 IU/kg). Before PCC administration, 45% of patients had an international normalized ratio (INR) greater than 2.0, and 36% had fibrinogen levels of at least 1.5 g/L. PCC produced statistically significant reductions in prothrombin time and INR (coadministration with fibrinogen or cryoprecipitate: 3.1 versus 1.9; P < 0.001; no coadministration: 2.3 versus 1.8; P < 0.001). Three patients with multiple risk factors developed thrombotic events (hepatic artery thrombosis, incidental bilateral pulmonary embolism, nonocclusive portal vein thrombosis); there were no cardiovascular or cerebrovascular adverse events. Overall, 46 patients died of causes unrelated to PCC treatment. Conclusion: In patients with liver disease, PCC therapy was effective in improving coagulation test results without an excess of thrombotic events. Further assessment of PCC as hemostatic therapy in this setting is required.

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The impact of prothrombin complex concentrates when treating DOAC-associated bleeding: a review.

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The impact of prothrombin complex concentrates when treating DOAC-associated bleeding: a review.

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