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The Use of 3- and 4-Factor Prothrombin Complex Concentrate in Patients With Elevated INR
Sanjay Mohan1, Mary Ann Howland1,2,3, Daniel Lugassy1
11 Ronald O. Perelman Department of Emergency Medicine, NYU School of Medicine, New York, NY, USA.
Insights
Four-factor prothrombin complex concentrate (PCC) and three-factor PCC effectively reduce elevated INR in patients with warfarin-related coagulopathy and non-warfarin-related coagulopathy, particularly when secondary to liver disease.
Area of Science:
- Hematology
- Pharmacology
Background:
- Four-factor prothrombin complex concentrate (PCC), Kcentra®, is FDA-approved for warfarin-related coagulopathy (WRC).
- Three-factor PCC (Bebulin®) and four-factor PCC are used off-label for non-WRC.
- Efficacy of 3- and 4-factor PCCs for non-WRC is not well-established.
Purpose of the Study:
- To characterize the utilization and effectiveness of 3- and 4-factor PCCs in patients diagnosed with non-WRC.
- To compare outcomes between WRC and non-WRC patients receiving PCCs.
Main Methods:
- Retrospective analysis of patients receiving PCCs for WRC and non-WRC from January 2012 to July 2015.
- Analysis included 187 patients with elevated international normalized ratio (INR).
Main Results:
- 53.9% of WRC patients and 27.7% of non-WRC patients achieved an INR ≤ 1.3 post-PCC administration.
- In non-WRC patients with liver disease, 3-factor PCC reduced mean INR by 0.98 and 4-factor PCC by 1.43.
Conclusions:
- Both three- and four-factor PCCs demonstrate efficacy in reducing INR for patients with WRC.
- PCCs are effective in lowering INR for non-WRC patients, especially those with underlying liver disease.
Background:
PCC (Kcentra®) is an Food and Drug Administration (FDA)-approved 4-factor PCC used for the treatment of warfarin-related coagulopathy (WRC), but it has also been used off-label to treat non-WRC. Three-factor PCC in the form of coagulation factor IX human (Bebulin®) has also been used for WRC and off-label to treat non-WRC. It is unclear whether the use of 3- or 4-factor PCCs is effective for the treatment of non-WRC,.
Objective:
Our aim is to characterize the use of 3- and 4-factor PCCs for patients identified with a non-WRC.
Methods:
A retrospective analysis of patients who received PCCs for both WRC and non-WRC between January 2012 and July 2015 was conducted.
Results:
A total of 187 patients with elevated international normalized ratio (INR) who received PCCs were analyzed; 53.9% of patients in the WRC group and 27.7% in the non-WRC group corrected to an INR of 1.3 or less after 3- or 4-factor PCC administration. In those patients with non-WRC and who had underlying liver disease, 3- and 4-factor PCCs reduced mean INR by 0.98 and 1.43, respectively.
Conclusion:
Three and 4-factor PCCs can reduce INR in patients with WRC and in those with non-WRC secondary to liver disease.
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