Efficacy and Safety of the Fixed-Dose Versus Variable-Dose of 4-PCC for Vitamin K Antagonist Reversal: A Comprehensive Systematic Review and Meta-Analysis

Background The optimal dosing strategy of four-factor prothrombin complex concentrate (4F-PCC) for vitamin K antagonists (VKAs) reversal is unknown. Methods We conducted systematic search on the PubMed, SCOPUS, and Embase databases from inception to December 2020 for clinical studies that compared t...

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Published in:Cardiovascular drugs and therapy 2022-06, Vol.36 (3), p.533-546
Main Authors: Mohammadi, Keyhan, Yaribash, Shakila, Sani, Mahmood Alizadeh, Talasaz, Azita Hajhossein
Format: Article
Language:English
Subjects:
Antagonists
Anticoagulants
Anticoagulants - adverse effects
Cardiology
Clinical outcomes
Confidence intervals
Dosage
Drug dosages
Fibrinolytic Agents
Humans
International Normalized Ratio
Medical research
Medicine
Medicine & Public Health
Meta-analysis
Mortality
Patients
Pharmacy
Phylloquinone
Prothrombin
Retrospective Studies
Review Article
Surgery
Systematic review
Thromboembolism
Thromboembolism - drug therapy
Vitamin K
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Summary:Background The optimal dosing strategy of four-factor prothrombin complex concentrate (4F-PCC) for vitamin K antagonists (VKAs) reversal is unknown. Methods We conducted systematic search on the PubMed, SCOPUS, and Embase databases from inception to December 2020 for clinical studies that compared the fixed-dose versus variable-dose of 4-PCC for VKAs reversal with at least one reported clinical outcome. The treatment effects were expressed as relative ratios (RR) with 95% confidence intervals (CIs) and pooled by a random-effects model. Results Ten studies, including 988 patients, were included. Fixed-dose 4-PCC was associated with lower rate of mortality (RR= 0.65, 95% CI 0.47 to 0.9, p = 0.009), comparable rate of thromboembolic event (TEE) (RR= 1.10, 95%CI 0.44 to 2.80, p = 0.826), and lower goal INR reached (RR= 0.87, 95%CI 0.78 to 0.96, p = 0.007). Less 4-PCC cumulative dose, shorter duration of order-to-needle time, similar hospital length of stay, the comparable time required for INR reversal, higher post-4-PCC INR, and a higher need for additional dose were observed in fixed-dose. Conclusions The use of a fixed-dose of 4-PCC may be considered an effective and safe dosing strategy for VKAs reversal in various clinical situations. However, further well-designed, controlled studies should be conducted focusing on clinical outcomes to determine the optimal dose of 4-PCC for VKAs reversal.
ISSN:0920-3206
1573-7241
DOI:10.1007/s10557-021-07192-0