Evaluation of Warfarin Reversal with 4-Factor Prothrombin Complex Concentrate Compared to 3-Factor Prothrombin Complex Concentrate at a Tertiary Academic Medical Center

Al-Majzoub, Omar; Rybak, Eva; Reardon, David P.; Krause, Patricia; Connors, Jean M.

doi:10.1016/j.jemermed.2015.07.024

Cited by 32 publications

(34 citation statements)

References 21 publications

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“…The proportion of patients who reached the goal INR was higher with PCC4 (87% vs. 31.6%, p < 0.001). Comparisons of PCC3 and PCC4 products for EWR have been done by others (17)(18)(19)(20)(21)(22)(23). Our study is similar to these other studies regarding retrospective design, PCC products compared, and the adult population.…”

Section: Discussionsupporting

confidence: 81%

“…Given the compositional differences in the PCC products, it is important to know if there are differences in clinical response for effective and safe use of these products. Studies evaluating the comparative effects of PCC3 and PCC4 head-to-head for EWR with the outcome of INR lowering response and/or clinical outcomes are few (17)(18)(19)(20)(21)(22)(23). The inclusion criteria for these studies vary, but all were in adult patients needing reversal of warfarin for bleeding, surgical intervention, and/or trauma associated bleeding.…”

Section: Introductionmentioning

confidence: 99%

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Propensity Score Adjusted Comparison of Three-Factor versus Four-Factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal: A Retrospective Cohort Study

Margraf

Seaburg

Beilman

et al. 2020

Preprint

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Background Prothrombin Complex Concentrates are prescribed for emergent warfarin reversal (EWR). Few direct comparisons with three-factor prothrombin complex concentrate (PCC3) and four-factor prothrombin complex concentrate (PCC4) exist. Patients in an academic level one trauma center who received PCC3 or PCC4 for EWR were identified. Patient characteristics, PCC dose and time of dose, pre- and post-INR and time of measurement, plasma and vitamin K doses, and patient outcomes were collected. Patients whose pre-PCC International Normalized Ratio (INR) was > 6 hours before PCC dose or the pre-post PCC INR was > 12 hours were excluded. The primary outcome was achieving an INR ≤ 1.5 post PCC. Secondary outcomes were the change in INR over time, post PCC INR, thromboembolic events (TE), and death during hospital stay. Logistic regression modelled the primary outcome with and without a propensity score adjustment accounting for age, sex, actual body weight, dose, initial INR value, and time between INR measurements. Data are reported as median (IQR) or n (%) with p < 0.05 considered significant. Results Eighty patients were included (PCC3 = 57, PCC4 = 23). More PCC4 patients achieved goal INR (87.0% vs. 31.6%, odds ratio (OR) = 14.4, 95% CI: 3.80-54.93, p < 0.001). The result was similar after adjusting for possible confounders (AOR = 10.7, 95% CI: 2.17–51.24, p < 0.001). The post-PCC INR was lower in the PCC4 group (1.3 (1.3–1.5) vs. 1.7 (1.5-2.0), p < 0.001. The INR change was greater for PCC4 (2.3 (1.3–3.3) vs. 1.1 (0.6-2.0), p = 0.003). Death during hospital stay (p = 0.52) and TE (p = 1.00) were not significantly different. Conclusions PCC4 was associated with a higher achievement of goal INR than PCC3. This relationship was observed in the unadjusted, propensity score adjusted, and time stratified results.

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

Propensity Score Adjusted Comparison of Three-Factor versus Four-Factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal: A Retrospective Cohort Study

Margraf

Seaburg

Beilman

et al. 2020

Preprint

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“…Activated recombinant activated factor VIIa and PCCs are better than fresh frozen plasma in reversing warfarin 201 ; PCC is better than recombinant activated factor VIIa 202 ; and 4-factor PCC appears to be more effective than 3-factor PCC. 188,203,204 …”

Section: Clinical Use Of Warfarinmentioning

confidence: 99%

Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy

Horlocker

Vandermeuelen

Kopp

et al. 2018

Regional Anesthesia and Pain Medicine

715

106

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“…10 A recent small, retrospective study by Al-Majzoub et al further demonstrated superior INR reversal of 4F-PCC compared to 3F-PCC in VKA-related bleeding. 13 Despite the 3F-PCC group also receiving a mean 3.66 units of plasma within 4 hours of infusion (vs none in the 4F-PCC group), the 4F-PCC group still had more patients reaching the primary endpoint of an INR ≤1.3 after treatment (42.9% vs 83.3%). Other outcomes such as hospital or intensive care unit (ICU) length of stay or survival to hospital discharge showed no significant differences between the two groups.…”

Section: Pcc Preparationsmentioning

confidence: 94%

“…Other outcomes such as hospital or intensive care unit (ICU) length of stay or survival to hospital discharge showed no significant differences between the two groups. 13 However, the study did not compare hemostatic efficacy between the two groups. Hospital or ICU length of stay and survival to discharge can be confounded by a host of other factors.…”

Section: Pcc Preparationsmentioning

confidence: 99%

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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Evaluation of Warfarin Reversal with 4-Factor Prothrombin Complex Concentrate Compared to 3-Factor Prothrombin Complex Concentrate at a Tertiary Academic Medical Center

Cited by 32 publications

References 21 publications

Propensity Score Adjusted Comparison of Three-Factor versus Four-Factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal: A Retrospective Cohort Study

Propensity Score Adjusted Comparison of Three-Factor versus Four-Factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal: A Retrospective Cohort Study

Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy

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

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