Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial

Goldstein, Joshua N.; Refaai, Majed A.; Milling, Truman J.; Lewis, Brandon; Goldberg-Alberts, Robert; Hug, Bruce A.; Sarode, Ravindra

doi:10.1016/s0140-6736(14)61685-8

Cited by 409 publications

(369 citation statements)

References 26 publications

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“…Dane z rejestrów wskazują, że skojarzone podanie osocza i koncentratu czynników zespołu protrombiny wiąże się z najmniejszą śmiertelnością po krwawieniu wewnątrzczaszkowym podczas stosowania VKA z INR ≥ 1,3 [506]. W wieloośrodkowej randomizowanej próbie klinicznej, obejmującej 188 pacjentów, koncentraty 4 czynników zespołu protrombiny pozwoliły na osiągnięcie szybszej normalizacji INR i skutecznej hemostazy niż osocze u pacjentów poddawanych pilnym zabiegom chirurgicznym i inwazyjnym [507]. Podanie koncentratów czynników zespołu protrombiny można również rozważyć w przypadku ciężkiego krwawienia w trakcie stosowania NOAC, jeżeli swoiste antidotum nie jest dostępne.…”

Section: Postępowanie W Przypadkuunclassified

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

Kirchhof

Benussi

Kotecha³

et al. 2016

Kardiol Pol

2,399

4,206

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Section: Postępowanie W Przypadkuunclassified

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

Kirchhof

Benussi

Kotecha³

et al. 2016

Kardiol Pol

2,399

4,206

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“…An integrated analysis of the studies by Sarode et al 25 and Goldstein et al 26 reported a similar incidence of TEEs between the 4F-PCC (14/191, 7.3%) and plasma groups (14/197, 7.1%). 31 However, these studies had a strict exclusion criteria and did not include certain patient groups such as those with a history of TEEs within 3 months of enrollment or history of antiphospholipid antibody.…”

Section: Risk Of Teesmentioning

confidence: 84%

“…26 Three percent of patients in the 4F-PCC group experienced fluid overload or a similar cardiac event vs 13% in the plasma group. The findings from these studies are summarized in Table 2.…”

Section: Gavva Et Almentioning

confidence: 94%

“…Compared to the previous standard of care, the PCC protocol resulted in a decrease in total blood volume transfused (2.45 L vs 4.20 L, p=0.037) and total units of blood products transfused (12 units vs 20 units, p=0.033) per patient. Interestingly, although PCC is more expensive than plasma, there was no significant difference in overall cost between the pre-PCC and post-PCC Table 2 Phase IIIb, multicenter, randomized, non-inferiority studies comparing efficacy of 4-factor prothrombin complex concentrate vs plasma for vitamin K antagonist reversal Sarode et al 25 Goldstein et al 26 …”

Section: Vka Reversal Prior To Cardiac Surgerymentioning

confidence: 99%

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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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“…In contrast, PCC, which only became widely used for warfarin reversal in the past decade, is available in smaller volumes and does not require matching or thawing, but is more expensive and may result in higher incidences of thromboembolic events [3]. Additionally, 4-factor PCC (KcentraV R , CSL Behring King of Prussia, PA) is unique in that in addition to clotting factors II, VII, IX, and X, it contains the natural anticoagulants C and S. The 4-factor PCC has been shown to be more effective than FFP in correcting the international normalized ratio (INR) and achieving hemostasis in warfarin patients without an increase in complications [5,6]. However, 4-factor PCC only became available in the United States in 2013, before which 3-factor PCC (ProfilnineV R , Grilfols Los Angeles, CA) was used, which has a significantly lower factor VII concentration, and lacks proteins C and S [3].…”

Section: Introductionmentioning

confidence: 99%

Retrospective study of rFVIIa, 4‐factor PCC, and a rFVIIa and 3‐factor PCC combination in improving bleeding outcomes in the warfarin and non‐warfarin patient

2016

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In case of severe bleeding, the physician must rapidly and effectively halt bleeding without the risk of thromboembolic complications. Despite widespread use, no study has directly compared recombinant activated factor VII (rFVIIa), the rFVIIa and 3‐factor prothrombin complex concentrate (PCC) combination (“combination”), and 4‐factor PCC on their effectiveness in improving patient outcomes. This study examined the medical records of 299 patients, 65.2% on warfarin prior to admission, who received these hemostatic agents and were admitted to an ICU or through the emergency department at Oregon Health & Science University. Mortality, length of stay, change in international normalized ratio (INR), plasma use, and number of thromboembolic complications were used to assess effectiveness. In patients receiving warfarin, the combination group had the greatest decrease in INR as well as lowest overall INR, but experienced a higher number of clotting complications, while the rFVIIa group used the most plasma. Non‐warfarin patients in the combination group had the shortest length of stay among survivors, but the rFVIIa group had the lowest mortality. Based on this data, it may be prudent to further study the use of rFVIIa in treating extreme bleeding in the non‐warfarin patient, while this study supports other data that 4‐factor PCC may be the most prudent for the warfarin patient. Am. J. Hematol. 91:705–708, 2016. © 2016 Wiley Periodicals, Inc.

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Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial

Abstract: CSL Behring.

Cited by 409 publications

References 26 publications

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

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

Retrospective study of rFVIIa, 4‐factor PCC, and a rFVIIa and 3‐factor PCC combination in improving bleeding outcomes in the warfarin and non‐warfarin patient

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