Key result
Administration of 4F-PCC for urgent VKA reversal in unselected patients resulted in a 6.2% incidence of thromboembolic events and 15% mortality, supporting its real-world safety.
Why the study?
What is the incidence of thromboembolic events and death in unselected patients receiving 4F-PCC for urgent VKA reversal?
Cohort (n=113)
What is the incidence of thromboembolic events and death in unselected patients receiving 4F-PCC for urgent VKA reversal?
In a real-world setting, 4F-PCC for urgent VKA reversal demonstrated an acceptable safety profile, with a 6.2% incidence of thromboembolic events.
Supports real-world safety of 4F-PCC for urgent VKA reversal; leaves open need for randomized confirmation in unselected patients.
BACKGROUND: A four-factor prothrombin complex concentrate (4F-PCC) was recently licensed in the United States for urgent vitamin K antagonist (VKA) reversal based on two randomized clinical trials. These studies excluded patients at high risk of thrombosis; therefore, the risk of thrombotic complications in unselected patients remains a concern. STUDY DESIGN AND METHODS: This study retrospectively evaluated the incidence of thromboembolic events (TEEs) and death in patients who received 4F-PCC for VKA reversal. The study included 113 consecutive patients who were 18 years of age and older and were administered 4F-PCC for VKA reversal. The incidence of TEE and deaths was evaluated for up to 60 days after PCC administration or until the end of hospitalization, whichever came later. RESULTS: Seven (6.2%) patients developed TEEs and 17 (15%) patients died. PCC administration was probably related to TEE and subsequent death in two (1.8%) patients. Multivariate analysis revealed that a diagnosis of Factor V Leiden or antiphospholipid syndrome was predictive of TEE, and active malignancy was predictive of death. CONCLUSION: This study supports the safety of 4F-PCC for urgent VKA reversal even in unselected patients. The underlying type of hypercoagulable state and the dose of PCC may influence the incidence of TEE.
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Joseph et al. (2015) conducted a cohort in Urgent vitamin K antagonist (VKA) reversal (n=113). Four-factor prothrombin complex concentrate (4F-PCC) was evaluated on Incidence of thromboembolic events (TEEs) and death. Administration of 4F-PCC for urgent VKA reversal in unselected patients resulted in a 6.2% incidence of thromboembolic events and 15% mortality, supporting its real-world safety.
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