Efficacy and safety of prothrombin complex concentrate for vitamin K antagonist-associated intracranial hemorrhage: a systematic review and meta-analysis
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Prothrombin complex concentrate (PCC) is the treatment of choice in vitamin K antagonist-associated intracranial hemorrhage (VKA-ICH). However, the efficiency and safety associated with their use remain unclear.
This study aimed to assess the current evidence of the clinical outcomes in patients with VKA-ICH treated with or without PCC.
Summary of review
A meta-analysis was conducted. Two randomized controlled trials and 19 observational studies were included. PCC use demonstrated a significant increased likelihood of international normalized ratio (INR) normalization (OR = 3.76; 95% CI 1.74–8.12), shortened time to INR correction (MD = − 1.30; 95% CI − 2.08 to − 0.53) and reduction of hematoma expansion (HE) rate (OR = 0.37; 95% CI 0.23–0.60). Although PCC use revealed a statistical reduction at 30-day mortality (OR = 0.62; 95% CI 0.50–0.78), the result was inconsistent with mortality at discharge (OR = 1.03; 95% CI 0.68–1.57) and 90-day follow-up (OR = 0.50; 95% CI 0.24–1.07), both of which yielded no significant difference. When subgroup analyses were performed focus on PCC only treatment with FFP, no statistically significant difference was observed in 30-day mortality (OR = 0.43; 95% CI 0.11–1.71) as well. Besides, significant difference was not found in neurologic improvement at discharge (OR = 1.85; 95% CI 0.32–10.75), 30-day follow-up (OR = 3.00; 95% CI 0.93–9.70), or 90-day follow-up (OR = 1.55; 95% CI 0.84–2.86). No statistically significant difference was noted in the risk of thromboembolism following PCC administration (OR = 0.61; 95% CI 0.23–1.63).
PCC use for VKA-ICH reversal was associated with a significant reduction in INR and HE rate, without an increased risk of thromboembolic events. However, this reduction was not associated with improvement in neurologic deficits or overall survival. Well-designed randomized trials with special considerations to the aspect are necessary.
KeywordsIntracranial hemorrhage Vitamin K antagonists Prothrombin complex concentrate Meta-analysis
The work was supported by the National Key R&D Program of China (2017YFC1307500, 2017YFC1307504) and Science and Technology Project of Huizhou City (2017C0416032).
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
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