Edoxaban Effects on Bleeding Following Punch Biopsy and Reversal by a 4-Factor Prothrombin Complex Concentrate

Zahir, Hamim; Brown, Karen; Vandell, Alexander G.; Desai, Madhuri; Maa, Jen-Fue; Dishy, Victor; Lomeli, Barbara; Feussner, Annette; Feng, Wenqin; He, Liang; Grosso, Michael; Lanz, Hans; Antman, Elliott M.

doi:10.1161/circulationaha.114.013445

Cited by 241 publications

(211 citation statements)

References 20 publications

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“…PCCs were effective in reducing bleeding in animal models of severe trauma during NOAC treatment 12. In healthy volunteers who received rivaroxaban or apixaban, PCCs (50 U/kg) reversed the effects on coagulation tests and biopsy‐induced bleeding 13, 14. Therefore, PCCs are recommended as a prohemostatic agent in patients treated with a factor Xa inhibitor who present with severe or life‐threatening bleeds not responding to conservative measures 15.…”

Section: Discussionmentioning

confidence: 99%

Neurosurgery in a patient at peak levels of rivaroxaban: taking into account all factors

Vlieger

Dietvorst

Demaerel

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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Essentials There is scant data on surgery shortly after intake of rivaroxaban.We performed neurosurgery using high dose PCCs and tranexamic acid.Intraoperative haemostasis was good and no transfusion was needed.There was no delayed postoperative haemotoma or thromboembolic complication. We present a patient who underwent urgent neurosurgery for acute onset paraplegia due to a spontaneous subdural spinal hematoma less than 5 hours after she had taken rivaroxaban. The Key Clinical Question was whether early high‐risk surgery on a patient taking direct oral anticoagulants is feasible. Prothrombin complex concentrate (PCC) and tranexamic acid were administered and perioperative hemostasis was good. There is scant data on neurosurgical procedures performed within 12 hours after the intake of a direct oral anticoagulant. With the hemostatic support of high‐dose PCC, early surgery after administration of rivaroxaban seems feasible in case of an emergency indication, but should only be considered when delaying surgery is esteemed hazardous to the patient. More experience is needed to allow balancing risks and benefits of urgent vs delayed intervention and on the optimal hemostatic support in the absence of a specific antidote.

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Section: Discussionmentioning

confidence: 99%

Neurosurgery in a patient at peak levels of rivaroxaban: taking into account all factors

Vlieger

Dietvorst

Demaerel

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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“…In one study, 50 u/kg of prothrombin complex concentrate was able to return bleeding after skin biopsy to normal in healthy volunteers receiving edoxaban. 72 There is less evidence for use of factor eight inhibitor bypassing agent or factor VIIa and a concern that such pre-activated agents may increase thrombotic events.…”

Section: Management Of Bleeding Complicationsmentioning

confidence: 99%

Drug therapy in anticoagulation: which drug for which patient?

Millar

Laffan

2017

Clinical Medicine

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Four non-vitamin K oral anticoagulants (NOACs) are now licensed and available in the UK, offering unprecedented choices in anticoagulant therapy for clinicians and patients. NOACs have many clear benefi ts over warfarin, the most striking being the reduction in intracranial haemorrhage. However, a number of uncertainties remain: their effi cacy in certain situations, utility of drug assays, signifi cance of drug interactions and management of bleeding. In the absence of any direct comparative trials, it is not clear that any of the NOACs is signifi cantly better than the others in any of the licensed indications. The differential activities, pharmacokinetics, metabolism, excretion and side effects of the agents should be considered when selecting the most appropriate anticoagulant. In this article, we discuss how, with careful selection for the relevant indication, NOACs can simplify therapy while improving outcomes. We aim to provide clinicians with the information needed to select the most suitable anticoagulant drug for an individual patient in a given situation. KEYWORDS : Anticoagulant therapy , non-vitamin K oral anticoagulants , NOACs IntroductionThe non-vitamin K oral anticoagulants (NOACs) 1 are now established in UK practice and new members continue to arrive. Within their licensed indications they have clear benefits over warfarin, but a number of uncertainties remain: efficacy in some specific situations, the utility of drug assays, significance of drug interactions and the management of bleeding all suffer from a paucity of data.This article provides an update on developments since the 2014 review in this journal.2 Our aim is to provide the information needed to select the most suitable anticoagulant drug for an individual patient in a given situation. ABSTRACTDrug therapy in anticoagulation: which drug for which patient? Properties of NOACsFour NOACs are now licensed and available in the UK: the direct factor Xa (FXa) inhibitors apixaban, edoxaban and rivaroxaban, and the direct thrombin inhibitor dabigatran. The key to best choice of agent lies in their individual pharmacokinetic profiles, metabolism and routes of excretion.

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“…49 A recent study by Zahir et al evaluated the effects of 4F-PCC in healthy volunteers who received a single dose of edoxaban (60 mg) and underwent a punch biopsy, a bleeding model developed by the authors. 50 4F-PCC at 50 IU/kg was able to fully restore ETP and reverse the anticoagulant effect on bleeding duration and blood loss, while 25 and 10 IU/kg had only partial and no effect respectively. Although 4F-PCC was unable to fully correct the PT, there was a dose-dependent response as 50 IU/kg had a greater reduction in PT than 25 and 10 IU/kg.…”

Section: F-pcc: Reversal Of Direct Factor Xa Inhibitorsmentioning

confidence: 87%

Four-factor prothrombin complex concentrates: effectiveness in the reversal of anticoagulation

Gavva¹,

Reddy²,

Sarode³

2017

IJCTM

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Vitamin K antagonists (VKAs) continue to be the most commonly prescribed class of oral anticoagulants worldwide for the treatment and prevention of venous or arterial thromboembolic events (TEEs). While VKAs are effective at reducing the incidence of TEEs, the risk of major bleeding remains significant. In patients taking VKAs and presenting with clinically significant bleeding or undergoing an emergent procedure, a rapid, effective, and safe reversal agent is required. Available options for the reversal of VKAs include plasma, vitamin K, 3-factor prothrombin complex concentrate (3F-PCC), or 4-factor prothrombin complex concentrate (4F-PCC). Herein, we review the growing evidence that supports using 4F-PCC over both plasma and 3F-PCC for emergent VKA reversal. We also discuss the various dosing options and safety profile of 4F-PCC. In addition, we summarize the limited data available for 4F-PCC in reversing the effects of direct oral anticoagulants and the management of other coagulopathic bleeding.

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Edoxaban Effects on Bleeding Following Punch Biopsy and Reversal by a 4-Factor Prothrombin Complex Concentrate

Cited by 241 publications

References 20 publications

Neurosurgery in a patient at peak levels of rivaroxaban: taking into account all factors

Neurosurgery in a patient at peak levels of rivaroxaban: taking into account all factors

Drug therapy in anticoagulation: which drug for which patient?

Four-factor prothrombin complex concentrates: effectiveness in the reversal of anticoagulation

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