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Clotting factor product administration and same‐day occurrence of thrombotic events, as recorded in a large healthcare database during 2008–2013
Author(s) -
Ekezue B. F.,
Sridhar G.,
Ovanesov M. V.,
Forshee R. A.,
Izurieta H. S.,
Selvam N.,
Parunov L. A.,
Jain N.,
Mintz P. D.,
Epstein J. S.,
Anderson S. A.,
Menis M. D.
Publication year - 2015
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.13155
Subject(s) - medicine , confounding , clotting factor , database , logistic regression , risk factor , retrospective cohort study , cohort study , venous thromboembolism , adverse effect , thrombosis , computer science
Summary Background Thrombotic events ( TE s) are serious adverse events that can occur following administration of clotting factors ( CF s). Objectives To evaluate occurrence of same‐day TE s for different CF products and potential risk factors. Methods A retrospective cohort study of individuals exposed to CF products during 2008–2013 was conducted using a large commercial insurance database. CF products were identified by procedure codes, and TE s were ascertained via diagnosis codes. Crude same‐day TE rates (per 1000 persons exposed) were estimated overall and by congenital factor deficiency ( CFD ) status, CF products, age and gender. Multivariable logistic regression analyses were used to control for confounding. Laboratory analysis was used to compare the procoagulant activities of FIX products. Results Of 3801 individuals exposed to CF s, 117 (30.8 per 1000) had same‐day TE s recorded. The crude same‐day TE rate was higher for CF users without CFD , 70.2 (102 of 1452), as compared with those with CFD , 6.4 (15 of 2349) ( RR , 11.0; 95% CI , 6.4–18.9). For individuals without CFD , a significantly increased same‐day TE risk was identified for factor IX complex ( OR , 6.92; 95% CI , 3.11–15.40), factor VII a ( OR , 9.42; 95% CI , 4.99–17.78) and other products when compared with fibrin sealant. An increased risk of a TE was found with older age (≥ 45 years), history of TE s and underlying health conditions. The laboratory identified elevated procoagulant activity in Profilnine ® and Benefix ® . Conclusions The study shows an increased same‐day TE risk for CF users without CFD and suggests substantial off‐label CF use. The study findings also show elevated same‐day TE rates for different CF products and suggest the importance of product properties and patient factors.