Off‐label use of 4‐factor prothrombin complex concentrate is common despite little known benefit: A retrospective study

Scharman, Carlton; Shatzel, Joseph J.; Kim, Edward; DeLoughery, Thomas G.

doi:10.1111/ejh.13105

Cited by 12 publications

(22 citation statements)

References 17 publications

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“…Our study also provides insight into the financial costs of 4F-PCC for both on-and off-label reasons. Interestingly, Scharman et al 23 noted that there was no difference in thromboembolic events, which our study could not evaluate accurately. Despite these differences, the conclusions from both studies support the finding that patients receiving 4F-PCC for off-label reasons have a higher in-hospital mortality rate.…”

Section: Discussionmentioning

confidence: 56%

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On‐label compared to off‐label four‐factor prothrombin complex concentrate use: a retrospective, observational study

et al. 2019

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BACKGROUND: Four-factor prothrombin complex concentrate (4F-PCC) is US Food and Drug Administration approved for the urgent reversal of coagulation factor deficiency induced by a vitamin K antagonist complicated by acute major bleeding or in situations in which invasive procedures are urgently needed. Although recent evidence suggests the superiority of 4F-PCC over plasma for on-label indications, the off-label use of 4F-PCC has not been rigorously studied. STUDY DESIGN AND METHODS: Eighty-ninepatients receiving 4F-PCC at a single institution from July 2016 to December 2017 were retrospectively analyzed. Two cohorts, "On-Label" and "Off-Label" uses of 4F-PCC, were evaluated, comparing patient characteristics, blood utilization, and clinical outcomes including in-hospital mortality.ABBREVIATIONS: 4F-PCC = four-factor prothrombin complex concentrate; CMI = case mix index; FFP = fresh frozen plasma; INR = international normalized ratio; VKAs = vitamin K antagonists; WAC = wholesale acquisition cost.From the

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Section: Discussionmentioning

confidence: 56%

“…To our knowledge, the only previous report of a direct comparison between on-versus off-label 4F-PCC use is by Scharman et al, 23 who evaluated 154 patients receiving 4F-PCC at a single institution. Similar to our findings, they found that patients receiving 4F-PCC for off-label reasons had a twofold higher in-hospital mortality.…”

Section: Discussionmentioning

confidence: 99%

On‐label compared to off‐label four‐factor prothrombin complex concentrate use: a retrospective, observational study

et al. 2019

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“…There was no difficulty in achieving therapeutic activated clotting time in these three patients. Median intensive care unit stay among all 11 patients was 2 [1-3] days and median hospitalization duration was 5 [2][3][4][5][6][7] days. No deaths occurred before discharge.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

Multicenter experience with andexanet alfa for refractory pericardial bleeding during catheter ablation of atrial fibrillation

Zghaib

Allison

Barrett

et al. 2023

Cardiovasc electrophysiol

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Introduction Pericardial bleeding is a rare but life‐threatening complication of atrial fibrillation (AF) ablation. Patients taking uninterrupted oral anticoagulation (AC) may be at increased risk for refractory bleeding despite pericardiocentesis and administration of protamine. In such cases, andexanet alfa can be given to reverse rivaroxaban or apixaban. In this study, we aim to describe the rate of acute hemostasis and thromboembolic complications with andexanet for refractory pericardial bleeding during AF ablation. Methods and Results In this multicenter, case series, participating centers identified patients who received a dose of apixaban or rivaroxaban within 24 h of AF ablation, developed refractory pericardial bleeding during the procedure despite pericardiocentesis and administration of protamine and received andexanet. Eleven patients met inclusion criteria, with mean age of 73.5 ± 5.3 years and median CHA2DS2‐VASc score 4 [3–5]. All patients received protamine and pericardiocentesis, and 9 (82%) received blood products. All patients received a bolus of andexanet followed, in all but one, by a 2‐h infusion. Acute hemostasis was achieved in eight patients (73%) while three required emergent surgery. One patient (9%) experienced acute ST‐elevation myocardial infarction after receiving andexanet. Therapeutic AC was restarted after a mean of 2.2 ± 1.9 days and oral AC was restarted after a mean of 2.9 ± 1.6 days, with no recurrent bleeding. Conclusion In patients on uninterrupted apixaban or rivaroxaban, who develop refractory pericardial bleeding during AF ablation, andexanet can achieve hemostasis thereby avoiding the need for emergent surgery. However, there is a risk of thromboembolism following administration.

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“…Os concentrados de complexo protrombínico possuem um papel bem estabelecido e investigado por ensaios clínicos randomizados para reversão rápida da anticoagulação com antagonista da vitamina K, com estudos comprovando redução da mortalidade, correção rápida do INR e sem aumento do risco de eventos tromboembólicos (Arachchillage et al, 2019;Margraf et al, 2022). No entanto, seu uso off-label aumentou expressivamente, alguns autores relataram até 40% das vezes, já numa coorte retrospectiva, a utilização off-label do CCP de 4 fatores (CCP-4) ocorreu em 76% dos pacientes tratados (Scharman et al, 2018;Roberts et al, 2021). Estas indicações ausentes na bula incluem principalmente a reversão da coagulopatia induzida pelos novos anticoagulantes orais diretos, tratamento ou profilaxia de sangramento de deficiências congênitas dos outros fatores da coagulação dependentes de vitamina K, pré-operatório para diminuir o sangramento em pacientes que não tomam anticoagulantes orais ou em um cenário de trauma com transfusões maciças (Nesek Adam & Bošan-Kilibarda, 2022).…”

Section: Discussão Composições Existentes E Indicações On-label E Off...unclassified

O papel do concentrado de complexo protrombrínico no manejo da coagulopatia induzida por trauma: uma revisão integrativa

Santos

Silva²,

Moura³

et al. 2023

RSD

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Introdução: O trauma é uma doença que vitimiza quase 6 milhões de pessoas todos os anos. O sangramento decorrente do trauma desencadeia uma coagulopatia complexa, que necessita de tratamento imediato para melhorar a sobrevida do paciente. O tratamento é baseado em remover a fonte de sangramento, utilizar hemoderivados e concentrados de fatores da coagulação, associado com hipotensão permissiva e reposição controlada de fluídos cristaloides. Objetivo: Avaliar os efeitos da utilização dos concentrados de complexo de protrombina no manejo da coagulopatia induzida por trauma no departamento de emergência. Metodologia: este estudo trata-se de uma revisão integrativa da literatura. O mecanismo de busca utilizado dentro das bases de dados foi: (Bleeding OR Hemorrhage OR Hemostasis OR “Blood Coagulation Disorders") AND (“Prothrombin Complex Concentrates”). Foram incluídos artigos de 2017 a 2022, textos completos disponíveis, em inglês, português e espanhol. Foram excluídos cartas, editoriais e relatos de caso, não correspondentes à temática e os duplicados. Resultados: Após a aplicação dos critérios de inclusão e exclusão, 37 artigos foram selecionados para leitura na íntegra, resultando numa amostra final de 15 artigos para compor esta revisão integrativa, sendo nove artigos da MEDLINE, cinco da SCOPUS e um da SCIENCEDirect. Conclusão: O concentrado de complexo de protrombina é um importante adjuvante no manejo da coagulopatia induzida por trauma, devido à capacidade para reduzir a razão normalizada internacional e a mortalidade sem aumentar o risco de eventos tromboembólicos.

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Off‐label use of 4‐factor prothrombin complex concentrate is common despite little known benefit: A retrospective study

Cited by 12 publications

References 17 publications

On‐label compared to off‐label four‐factor prothrombin complex concentrate use: a retrospective, observational study

On‐label compared to off‐label four‐factor prothrombin complex concentrate use: a retrospective, observational study

Multicenter experience with andexanet alfa for refractory pericardial bleeding during catheter ablation of atrial fibrillation

O papel do concentrado de complexo protrombrínico no manejo da coagulopatia induzida por trauma: uma revisão integrativa

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