Outcome of intracranial bleeding managed with prothrombin complex concentrate in patients on direct factor Xa inhibitors or vitamin K antagonists. Issue 196 (December 2020)

• Record Type: Journal Article
• Authors: Bavalia, Roisin; Abdoellakhan, Rahat; Beenen, Ludo F.; Brekelmans, M.P.A.; Olie, Renske H.; ten Cate, Hugo; Huisman, Menno V.; Kruip, Marieke; Middeldorp, Saskia; Meijer, Karina; Hutten, Barbara A.; Coppens, Michiel
• Is Part Of: Thrombosis research. Issue 196(2020)
• Page Start: 404
• Page End: 409
• Publication Date: 2020-12
• Subjects: Thrombosis -- Periodicals; 616.135
• DOI: 10.1016/j.thromres.2020.09.028
• Languages: English
• ISSNs: 0049-3848

Abstract

Abstract: Intracranial hemorrhage (ICH) is the most feared complication of anticoagulation with a high mortality and morbidity. Before registration of a specific reversal agent for factor Xa inhibitors (FXa-I), international guidelines recommended prothrombin complex concentrate (PCC), which also is the specific reversal agent for vitamin K antagonists (VKA). In two contemporary cohorts, we compared clinical outcomes between patients with FXa-I and VKA related ICH treated with PCC between 2014 and 2018. Primary outcome was effective hemostasis after 24 h, according to the International Society of Thrombosis and Hemostasis definition. Safety outcomes were defined as venous and arterial thromboembolic complications and death within 30 days. Thirty-six patients with FXa-I-ICH and 39 patients with VKA-ICH were available for analysis. Baseline characteristics were comparable between both groups, except for time from start of symptoms to presentation at the hospital. In the FXa-I-ICH cohort, 24 (73%) patients achieved effective hemostasis compared to 23 (62%) patients in the VKA-ICH cohort (crude odds ratio [OR] 1.62 [95%CI 0.59–4.48], adjusted OR 1.45 [95%CI 0.44–4.83]). Eight (24%) patients with FXa-I-ICH deceased compared to 17 (45%) patients with VKA-ICH (crude OR 0.38 [95%CI 0.14–1.24], adjusted OR 0.41 [95%CI 0.12–1.24]). In this observational cohort study, the outcome of ICH managed with PCC was similar in patients with FXa-I-ICH and in patients with VKA-ICH. Highlights: Outcome of major bleeding is similar in FXa-I and VKA-ICH patients treated with PCC. Our findings insinuate PCC may be effective for FXa-I-ICH management The lack of a specific FXa-I antidote is unlikely to affect the prognosis of ICH.