Epidemiology of Intracranial Haemorrhages Associated with Vitamin K Antagonist Oral Anticoagulants in Spain: TAC Registry

Abstract

Background: Vitamin K antagonist oral anticoagulants (VKA-OACs) are effective for primary and secondary prevention of embolic events. The rate of haemorrhagic neurological complications in patients admitted to neurology departments in Spain is not yet known. Aims: We aimed to determine the clinical and epidemiological characteristics of patients with intracranial haemorrhage secondary to VKA-OACs as well as the incidence of this severe complication. Methods: We conducted a retrospective, descriptive, multi-centre study using information from the medical records of all patients admitted to neurology departments, diagnosed with spontaneous intracranial haemorrhage, and treated with VKA-OACs within a 1-year period. We collected demographic and care data from centres, patients' medical records [demographic data, medical history, haemorrhage origin, vascular risk factors, concomitant treatment, and National Institutes of Health Stroke Scale (NIHSS) scores], and patients' outcome at 3 months [independence (modified Rankin Scale score <3) and mortality rate]. Results: Twenty-one hospitals serving a population of 8,155,628 inhabitants participated in the study. The total number of cases was 235, the mean age was 78.2 (SD 9.4) years, and the baseline NIHSS score was 11.6 (SD 9.5; median 9; interquartile range 14). The VKA-OACs used were acenocoumarol in 95.3% (224 patients) and warfarin in 4.7% (11 patients). The haemorrhage origin was deep in 29.8%, lobar in 25.5%, intraventricular in 11.5%, extensive in 17.4% (>100 ml), cerebellar in 12.3%, and in the brainstem in 3.4%. The international normalised ratio was within therapeutic ranges at admission (according to indication) in 29.4% (69 patients). The global incidence (cases per 100,000 inhabitants per year) is 2.88. The in-hospital mortality rate was 40%, and 24.3% of the patients were independent at 3 months, while the mortality at 3 months was 42.6%. Conclusion: VKA-OAC treatment is associated with a large percentage of all cases of spontaneous intracranial haemorrhage, an event leading to high dependence and mortality rates.

Early Outcome after Intracranial Hemorrhage Related to Non-Vitamin K Oral Anticoagulants

“…A Spanish retrospective analysis from 2014 reported a very similar 40% mortality rate and a favorable outcome in only 25% of all patients [15]. A recent German prospective, multicenter, observational study of nontraumatic NOAC-related ICH reported a 28% mortality rate and a favorable outcome in 25% of the patients [16].…”

“…Initial studies reported a mortality rate of 52-67% [14]. With time, the results improved and the described mortality rate was 28-40%, whereas a favorable outcome was observed in 10-35% [15,16,17]. In a recent study, the outcome appeared to be similar to that of VKA-related ICH [17].…”

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

“…The risk of intracranial hemorrhage (ICH) in patients receiving VKAs is 0.3-3%, i.e., an 8-to 10-fold greater risk than in patients who do not take VKAs [3,4]. Furthermore, not only is the risk of ICH increased, but once the hemorrhage occurs, the initial volume [5], risk of expansion, severity, and probability of death are also higher [6,7].…”

“…Furthermore, not only is the risk of ICH increased, but once the hemorrhage occurs, the initial volume [5], risk of expansion, severity, and probability of death are also higher [6,7]. The mortality rate of ICH is 40-67% [3,4,6], and the probability of functional recovery is 17-24.3% [3].…”

Hemorrhage After Lunch?

“…According to beliefs one of the most serious internal hemorrhage is the cerebral haemorrhage which is one (but less common) form of stroke [1]. Bleedings are known side effects of vitamin K antagonist therapy that is often used to prevent obstructive (ischemic) stroke [2]. Vitamin K deficiency bleeding (VKDB) was first realized as hemorrhagic disease of newborns, but today more cases are to be seen in connection with vitamin K antagonist therapy in the elderly.…”