Diana Felton1, Elizabeth M Foley1, Stephen J Traub2, Alina Vodonos3, Michael Ganetsky1. 1. Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. 2. Department of Emergency Medicine, Mayo Clinic Hospital, Phoenix, Arizona. 3. Department of Public Health, Ben Gurion University of the Negev, Soroka Clinical Research Center, Soroka University Medical Center, Beersheba, Israel.
Abstract
BACKGROUND: Prothrombin complex concentrates (PCCs) are commonly used to rapidly reverse warfarin-associated coagulopathy; however, venous thromboembolism (VTE) is an established adverse event. OBJECTIVE: To determine risk factors for VTE AFTER administration of a three-factor prothrombin complex concentrate (3F-PCC) for warfarin-associated intracranial hemorrhage (ICH). METHODS: Retrospective chart review of all patients with a warfarin-associated ICH who received a 3F-PCC at a single tertiary care hospital between 2008 and 2013. Outcomes were VTE events (defined as deep vein thrombosis [DVT], pulmonary embolism [PE], limb ischemia, transient ischemic attack, cerebrovascular accident, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction, and unexplained sudden death) occurring within 30 days of 3F-PCC administration. Risk factors in subjects with and without VTE complications were compared via Fisher's exact test, Student's t-test, Mann-Whitney U test, and univariate logistic regression as appropriate. RESULTS: Two hundred nine subjects received 3F-PCC for warfarin-associated ICH. There were 22 VTE events in 19 subjects (9.1%). Baseline characteristics of subjects with and without VTE were similar. There was a significant increase in VTE events in 29 subjects who were taking warfarin for a previous PE or DVT (36.8% vs. 11.6%, p = 0.007; logistic regression odds ratio 4.455, p = 0.005). CONCLUSIONS: Patients with a prior history of PE or DVT who were given 3F-PCC for warfarin-associated ICH were 4.5 times more likely to sustain a VTE within 30 days. A careful analysis of risks and benefits of rapidly reversing anticoagulation must be made prior to the administration of 3F-PCC in this patient population.
BACKGROUND: Prothrombin complex concentrates (PCCs) are commonly used to rapidly reverse warfarin-associated coagulopathy; however, venous thromboembolism (VTE) is an established adverse event. OBJECTIVE: To determine risk factors for VTE AFTER administration of a three-factor prothrombin complex concentrate (3F-PCC) for warfarin-associated intracranial hemorrhage (ICH). METHODS: Retrospective chart review of all patients with a warfarin-associated ICH who received a 3F-PCC at a single tertiary care hospital between 2008 and 2013. Outcomes were VTE events (defined as deep vein thrombosis [DVT], pulmonary embolism [PE], limb ischemia, transient ischemic attack, cerebrovascular accident, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction, and unexplained sudden death) occurring within 30 days of 3F-PCC administration. Risk factors in subjects with and without VTE complications were compared via Fisher's exact test, Student's t-test, Mann-Whitney U test, and univariate logistic regression as appropriate. RESULTS: Two hundred nine subjects received 3F-PCC for warfarin-associated ICH. There were 22 VTE events in 19 subjects (9.1%). Baseline characteristics of subjects with and without VTE were similar. There was a significant increase in VTE events in 29 subjects who were taking warfarin for a previous PE or DVT (36.8% vs. 11.6%, p = 0.007; logistic regression odds ratio 4.455, p = 0.005). CONCLUSIONS:Patients with a prior history of PE or DVT who were given 3F-PCC for warfarin-associated ICH were 4.5 times more likely to sustain a VTE within 30 days. A careful analysis of risks and benefits of rapidly reversing anticoagulation must be made prior to the administration of 3F-PCC in this patient population.