POST-NOAC: Portuguese observational study of intracranial hemorrhage on non-vitamin K antagonist oral anticoagulants

Abstract

Background There is a lower reported incidence of intracranial hemorrhage with non-vitamin K antagonist oral anticoagulants compared with vitamin K antagonist. However, the functional outcome and mortality of intracranial hemorrhage patients were not assessed. Aims To compare the outcome of vitamin K antagonists- and non-vitamin K antagonist oral anticoagulants-related intracranial hemorrhage. Methods We included consecutive patients with acute non-traumatic intracranial hemorrhage on oral anticoagulation therapy admitted between January 2013 and June 2015 at four university hospitals. Clinical and demographic data were obtained from individual medical records. Intracranial hemorrhage was classified as intracerebral, extra-axial, or multifocal using brain computed tomography. Three-month functional outcome was assessed using the modified Rankin Scale. Results Among 246 patients included, 24 (9.8%) were anticoagulated with a non-vitamin K antagonist oral anticoagulants and 222 (90.2%) with a vitamin K antagonists. Non-vitamin K antagonist oral anticoagulants patients were older (81.5 vs. 76 years, p = 0.048) and had intracerebral hemorrhage more often (83.3% vs. 63.1%, p = 0.048). We detected a non-significant trend for larger intracerebral hemorrhage volumes in vitamin K antagonists patients ( p = 0.368). Survival analysis adjusted for age, CHADSVASc, HAS-BLED, and anticoagulation reversal revealed that non-vitamin K antagonist oral anticoagulants did not influence three-month mortality (hazard ratio (HR) = 0.83, 95% confidence interval (CI) = 0.39-1.80, p = 0.638). Multivariable ordinal regression for three-month functional outcome did not show a significant shift of modified Rankin Scale scores in non-vitamin K antagonist oral anticoagulants patients (odds ratio (OR) 1.26, 95%CI 0.55-2.87, p = 0.585). Conclusions We detected no significant differences in the three-month outcome between non-vitamin K antagonist oral anticoagulants- and vitamin K antagonists-associated intracranial hemorrhage, despite unavailability of non-vitamin K antagonist oral anticoagulants-specific reversal agents.

Epidemiology of Intracranial Hemorrhage Associated with Oral Anticoagulants in Spain: Trends in Anticoagulation Complications Registry – The TAC 2 Study

“…Therefore, in our study, it was noteworthy that in ICH-DOACs, the bleed was smaller, an intraventricular component was less frequent, and stroke-related mortality was lower than in ICH-VKAs (all differences statistically significant). In other studies [4,21,30], there was also a greater trend toward functional independence at 3 months, which in our study, as in a recent study in Portugal [22], did not reach statistical significance.…”

“…Observational studies [21,22] showed that ICH-DOACs had a greater previous risk of hemorrhage than ICH-VKAs. In our study, both age and frequency of previous ischemic stroke were higher in the ICH-DOAC group.…”

Outcome of intracerebral haemorrhage related to non-vitamin K antagonists oral anticoagulants versus vitamin K antagonists: a comprehensive systematic review and meta-analysis

“…It is possible that patients received non-specific reversal treatments (eg, Prothrombin complex concentrates (PCC)), as was indeed the case in three studies,14 27 28 but such information was not systematically available or extractable from all studies. Only five patients were reported to have received idarucizumab (a humanised antibody fragment released in 2015 acting as a specific reversal agent to dabigatran) 18. The effect of NOAC specific reversal on the acute features of ICH are largely unexplored to date, and the question whether patients with ICH receiving NOAC reversal agents would show smaller final haematoma volumes, demonstrates less frequent haemorrhage expansion and achieve better clinical outcomes remains open 31 32.…”

Neuroimaging and clinical outcomes of oral anticoagulant–associated intracerebral hemorrhage

“…After retrieving the full-text version of the aforementioned 12 studies, 3 studies were excluded because they included patients with traumatic brain injury 23-25 and 1 study due to the lack of a VKA-ICH comparator group (Supplementary Table 2). [28][29][30][31][32][33][34] Prior to applying our own inclusion and exclusion criteria, we received 100% of expected patient numbers from each study (Supplementary Table 3). Individual patient data were obtained from all study protocols, except for one, 27 and the 7 eligible studies were finally included in the qualitative and quantitative synthesis (Fig 1).…”