Key result
Four-factor prothrombin complex concentrates were effective for VKA reversal in 97.1% of patients and achieved bleeding cessation in 56.7% of massive bleeding events, with a 3.1% thrombosis rate.
Why the study?
Data concerning the efficacy, safety, and dosing of prothrombin complex concentrates for off-label indications are limited despite their inclusion in massive bleeding protocols.
Does four-factor prothrombin complex concentrate improve bleeding cessation and INR normalization in patients requiring urgent anticoagulant reversal or with bleeding coagulopathy?
Observational (n=328)
Does four-factor prothrombin complex concentrate improve bleeding cessation and INR normalization in patients requiring urgent anticoagulant reversal or with bleeding coagulopathy?
4F-PCC demonstrates effectiveness and an acceptable safety profile for both approved VKA reversal and off-label indications such as refractory coagulopathy and DOAC reversal.
Answers are grounded in this paper and cite their sources.
May inform off-label 4F-PCC dosing in bleeding protocols; leaves open need for prospective trials on efficacy and safety.
OBJECTIVE: To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off-label indications. BACKGROUND: PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off-label indications are limited, but they are included in massive bleeding protocols. METHODS: This was a retrospective review of cases treated with four-factor PCCs (4F-PCCs) between January 2009 and 2016. Efficacy end-points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (<1·5) and (ii) clinical efficacy as bleeding cessation and/or decreased number of transfused blood components and 24-h mortality in bleeding coagulopathy. The safety end-point is the incidence of thromboembolic events. RESULTS: A total of 328 patients were included (51·8% male, median age 78 years old). Indications were as follows: VKA reversal (66·6%), bleeding coagulopathy (30·5%) and direct anticoagulant (DOAC) reversal due to bleeding (2·5%). VKA reversal was effective in 97·1% of patients, and 76·5% demonstrated complete reversal (INR < 1·5); only 34·3% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88·9% of patients. Bleeding cessation was associated with the dose administered (P = 0·002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56·7% of massive bleeding events and in 42·5% of other coagulopathies; 24-h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3·1%). CONCLUSION: 4F-PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.
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Marcos‐Jubilar et al. (2019) conducted an observational in Patients requiring urgent reversal of vitamin K antagonists, bleeding coagulopathy, or DOAC reversal (n=328). Four-factor prothrombin complex concentrates (4F-PCCs) was evaluated on VKA reversal efficacy (INR <1.5), clinical efficacy (bleeding cessation/decreased transfusions), and 24-h mortality. Four-factor prothrombin complex concentrates were effective for VKA reversal in 97.1% of patients and achieved bleeding cessation in 56.7% of massive bleeding events, with a 3.1% thrombosis rate.
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