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

Objective: Patients receiving treatment with oral anticoagulants (OACs) are at risk of intracranial hemorrhage (ICH). In this study, we describe the epidemiological and clinical characteristics of patients receiving OACs who experience ICH and compare those receiving vitamin K antagonists (ICH-VKAs) with those receiving direct OACs (ICH-DOACs).

Methods: We performed a national, multicenter, descriptive, observational, retrospective study of all adult patients receiving OACs who were admitted to the neurology department with ICH over a 1-year period. The study population was divided into 2 groups (ICH-VKAs and ICH-DOACs). Epidemiological, clinical, radiological, and therapy-related variables, as well as functional outcome, were compared at 3 months. A total of 366 cases were included (331 ICH-VKAs, 35 ICH- DOACs).

Results: The crude annual incidence of OAC-induced ICH was 3.8 (95% CI, 2.78-3.41) per 100,000 inhabitants/year. The mean (± SD) age was greater for ICH-DOACs (81.5 ± 8.3 vs. 77.7 ± 8.3 years; 0.012). The median (IQR) volume of the hemorrhage was lower for ICH-DOACs (11 [30.8] vs. 25 [50.7] mL; 0.03). The functional independence rate at 3 months (modified Rankin Scale, mRS < 3) was similar in both groups, although stroke-related mortality was greater in ICH-VKAs (40 vs. 72.7%; 0.02). The most frequently indicated poststroke antithrombotic therapy was DOACs (38.7%).

Conclusion: We found that the incidence of OAC-induced ICH was greater than in previous studies. Hemorrhage volume and mortality were lower in ICH-DOACs than in ICH-VKAs. After stroke, DOACs were the most frequently indicated antithrombotic treatment.