![]() ![]() Research in the American Heart Association’s Get with the Guidelines Stroke registry also found a high burden of in-hospital mortality of 27% for patients with spontaneous intracerebral hemorrhage in the presence of FXa inhibitors, with odds of mortality being significantly higher for patients taking FXa inhibitors compared to those who do not take anticoagulants, but significantly lower compared to those taking warfarin. The previous literature has shown that antithrombotic-related intracranial hemorrhages can result in a high clinical burden, with in-hospital mortality rates of 12.4% for traumatic and 29% for non-traumatic intracranial hemorrhage. While DOACs are associated with a decreased risk of intracranial hemorrhage compared to vitamin K antagonists (VKAs), these life-threatening bleeds were observed in DOAC-treated patients at a rate of approximately 0.7%/year in randomized trials. Since their approval by the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) in 2010, direct-acting oral anticoagulants (DOACs) and in particular the factor Xa (FXa) inhibitors apixaban and rivaroxaban have been increasingly utilized to treat or prevent various thrombotic disease states. ![]() Trial registration NCT02329327 registration date: December 31, 2014. In this indirect comparison of patients with an apixaban- or rivaroxaban-associated ICH, andexanet alfa was associated with better hemostatic effectiveness and improved survival compared to 4F-PCC. ![]() Two thrombotic events occurred with andexanet alfa and none with 4F-PCC. Andexanet alfa was associated with greater odds of achieving hemostatic effectiveness (85.8% vs. ICH size was ≥ 10 mL in volume (intracerebral and/or ventricular) or ≥ 10 mm in thickness (subdural or subarachnoid) in 22% of patients and infratentorial in 15%. Most ICHs were single compartment (78%), trauma-related (61%), and involved the intracerebral and/or intraventricular space(s) (53%). Atrial fibrillation was present in 86% of patients. After propensity score-overlap weighting, mean age was 79 years, GCS was 14, time from initial scan to reversal initiation was 2.3 h, and time from reversal to repeat scan was 12.2 h in both arms. The study included 107 andexanet alfa (96.6% low dose) and 95 4F-PCC patients (79.3% receiving a 25 unit/kg dose). Odds ratios (ORs) with 95% confidence intervals (CI) were calculated using propensity score-overlap weighted logistic regression. Outcomes were hemostatic effectiveness from index to repeat scan, mortality within 30 days, and thrombotic events within five days. ![]() Adults with radiographically confirmed ICH who took their last dose of apixaban or rivaroxaban 60 mL, or planned surgery within 12 h were excluded. This two-cohort comparison study included andexanet alfa patients enrolled at US hospitals from 4/2015 to 3/2020 in the prospective, single-arm ANNEXA-4 study and a synthetic control arm of 4F-PCC patients admitted within a US healthcare system from 12/2016 to 8/2020. We evaluated the effectiveness and safety of andexanet alfa versus 4F-PCC for management of apixaban- or rivaroxaban-associated intracranial hemorrhage (ICH). Four-factor prothrombin complex concentrates (4F-PCC) are commonly used as an off-label, non-specific, factor replacement approach to manage FXa inhibitor-associated life-threatening bleeding. Andexanet alfa is approved (FDA “accelerated approval” EMA “conditional approval”) as the first specific reversal agent for factor Xa (FXa) inhibitor-associated uncontrolled or life-threatening bleeding. ![]()
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