Clinical Relevance of Preclinical and Clinical Studies of Four-Factor Prothrombin Complex Concentrate for Treatment of Bleeding Related to Direct Oral Anticoagulants

Sarode, Ravindra; Welsby, Ian J.; Hoffman, Maureane

doi:10.1016/j.annemergmed.2023.04.015

Cited by 4 publications

(2 citation statements)

References 93 publications

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“…A meta-analysis done by Chaudhary et al ( 36 ) revealed an anticoagulation reversal rate of 82%, a mortality rate of 11%, and a thromboembolic rate of 5% after idarucizumab application in patients with ICH ( 36 ), which is in line with the RE-VERSE AD study results. Based on the analysis of available published data, all authors support the use of idarucizumab in ICH ( 34–37 , 39 ), which is also reflected in clinical practical guidelines written by Joglar et al ( 8 ). In a review by Al Aseri et al ( 34 ), authors additionally addressed the concern of limited availability of specific reversal agents in various countries and stressed the urgent need of availability and accessibility for developing local guidelines to direct their use ( 34 ).…”

Section: Real-world Data On Idarucizumab Use In Acute Stroke Patientsmentioning

confidence: 86%

“…Five review articles ( 34–37 , 39 ) addressed the use of idarucizumab regarding its use in ICH. A meta-analysis done by Chaudhary et al ( 36 ) revealed an anticoagulation reversal rate of 82%, a mortality rate of 11%, and a thromboembolic rate of 5% after idarucizumab application in patients with ICH ( 36 ), which is in line with the RE-VERSE AD study results.…”

Section: Real-world Data On Idarucizumab Use In Acute Stroke Patientsmentioning

confidence: 99%

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Idarucizumab in dabigatran-treated patients with acute stroke: a review and clinical update

Frol,

Pretnar Oblak,

Šabovič

et al. 2024

Front. Neurol.

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Idarucizumab is an antibody fragment specific for the immediate reversal of dabigatran anticoagulation effects. The use of idarucizumab is approved for dabigatran-treated patients suffering from life-threatening or uncontrolled bleeding and those in need of urgent surgery or invasive procedures. Data from randomized controlled clinical trials and real-world experience provide reassuring evidence about the efficacy and safety of idarucizmab use in patients with acute stroke. In this narrative review, we summarize the available real-world evidence and discuss the relevance and importance of idarucizumab treatment in acute stroke patients in everyday clinical practice. In addition, we also discuss special issues like prothrombin complex concentrate application as an alternative to idarucizumab, its application before endovascular therapy, sensitivity of thrombi to lysis, and necessary laboratory examinations.

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Section: Real-world Data On Idarucizumab Use In Acute Stroke Patientsmentioning

confidence: 86%

Section: Real-world Data On Idarucizumab Use In Acute Stroke Patientsmentioning

confidence: 99%

Idarucizumab in dabigatran-treated patients with acute stroke: a review and clinical update

Frol,

Pretnar Oblak,

Šabovič

et al. 2024

Front. Neurol.

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Reversal of pre-injury factor-Xa inhibitors with prothrombin complex concentrates in patients following traumatic brain injury

Barletta,

Shirah,

Mangram

et al. 2023

Clinical Neurology and Neurosurgery

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Long-Term Safety of a Four-Factor Prothrombin Complex Concentrate (Kcentra®/Beriplex® P/N): An Updated Pharmacovigilance Review

Milling,

Voronov,

Schmidt

et al. 2024

Thromb Haemost

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Introduction Four-factor prothrombin complex concentrate (4F-PCC) is recommended for vitamin K antagonist reversal in patients with major bleeding or in need of surgery. The most important risk associated with the use of 4F-PCC is the occurrence of thromboembolic events (TEEs). In this review, we aim to evaluate the safety profile of a 4F-PCC (Kcentra®/Beriplex® P/N; CSL Behring, Marburg, Germany) by reviewing pharmacovigilance data. Methods A retrospective analysis of postmarketing pharmacovigilance data of Kcentra®/Beriplex® P/N from February 1996 to April 2022 was performed and complemented by a review of clinical studies published between January 2012 and April 2022. Results A total of 2,321,443 standard infusions of Kcentra®/Beriplex® P/N were administered during the evaluation period. Adverse drug reactions (ADRs) were reported in 614 cases (∼1 per 3,781 standard infusions) and 233 of these cases (37.9%) experienced suspected TEEs related to 4F-PCC (∼1 per 9,963 standard infusions); most of these cases had pre-existing or concomitant conditions likely to be significant risk factors for thrombosis. TEE rates were similar when 4F-PCC was used on-label or off-label for direct oral anticoagulant-associated bleeding. Thirty-six cases (5.9%) reported hypersensitivity type reactions (∼1 per 64,485 standard infusions). No confirmed case of viral transmission related to 4F-PCC use was reported. The published literature also revealed a favorable safety profile of 4F-PCC. Conclusion Analysis of postmarketing pharmacovigilance safety reports demonstrated that treatment with 4F-PCC was associated with few ADRs and a low rate of TEEs across multiple indications and settings, thus confirming a positive safety profile of 4F-PCC.

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Clinical Relevance of Preclinical and Clinical Studies of Four-Factor Prothrombin Complex Concentrate for Treatment of Bleeding Related to Direct Oral Anticoagulants

Cited by 4 publications

References 93 publications

Idarucizumab in dabigatran-treated patients with acute stroke: a review and clinical update

Idarucizumab in dabigatran-treated patients with acute stroke: a review and clinical update

Reversal of pre-injury factor-Xa inhibitors with prothrombin complex concentrates in patients following traumatic brain injury

Long-Term Safety of a Four-Factor Prothrombin Complex Concentrate (Kcentra®/Beriplex® P/N): An Updated Pharmacovigilance Review

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