156 Rivaroxaban in very elderly patients with atrial fibrillation
Authors: Lamaida Norman , Cristiano Giuseppina , Cerciello Antonio 
Published: December 2021

Abstract

Aims
The incidence of atrial fibrillation (AF) increases with age. The risk of stroke is increased 4- to 5-fold in old patients with AF. In the Framingham Study, 23.5% of strokes in patients aged 80 and older were attributable to AF. Advanced age is also associated with a progressive increase in the risk of major bleeding in subjects ≥85 years, particularly if treated by oral anticoagulants (OAC). Only 20% of patients &gt;75 years were included in randomized controlled trials (RCTs) involving OACs in AF, due to the high risk of falls and bleeding, especially intracranial haemorrhage (ICH). The management of anticoagulation in the very elderly represents a challenging issue because they are at high thromboembolic risk, and also at high haemorrhagic risk. The aim of our study was to describe the use and tolerability of rivaroxaban in very old patients with heart failure with reduced ejection fraction. The average age of enrolled patients is 76.0 ± 8.4 years with a significant prevalence of the elderly (16.0% with age ≥85 years with a slight male prevalence).

Methods
We analysed retrospective data from 50 patients from June 2016 to June 2018 and taking rivaroxaban 20 mg. The average age of enrolled patients was 76 ± 8.2 years and 40% were females. The inclusion criteria were patients with at least one episode of documented AF of any duration in the preceding 12 months. The average CHA2DS2-VASc of these subjects is 3.2 ± 1.4, while the haemorrhagic risk expressed by the HAS-BLED appears more contained (2.7 ± 1.1). The risk profile of these patients was complex as documented by an older age, by a CHA2DS2-VASc higher and by the prevalence of comorbidities such as heart failure, valvular disease, peripheral vasculopathy and diabetes mellitus. Follow-up, characterized by clinical examination and blood analysis, was performed at 3, 6, and 12 months. The AF patients were followed for the effectiveness outcome of thromboembolism (ischaemic stroke and/or systemic embolism) and bleeding outcomes (composite of major bleeding, gastrointestinal bleeding, and intracranial Haemorrhage), as well as bleeding requiring hospitalization. A secondary safety endpoint was total minor bleedings. Standard two-dimensional transthoracic echocardiographic examination was performed. Left ventricular end-diastolic volume, end-systolic volume, and ejection fraction (LVEF) were measured using the modified Simpson’s rule from the apical view.

Results
During follow-up, we observed no major bleedings, strokes, or cardiovascular deaths. Only two minor haemorrhages (one epistaxis and one haematuria, none of which required blood transfusion or hospital admission) observed with no differences observed in LVEF or left atrial dimension at echocardiography, body mass index, and the thrombotic and haemorrhagic risk profile.

Conclusions
Such data confirm that the new oral anticoagulants, and in particular rivaroxaban, are considered safe even in the most population frail and above all elderly, allowing for enlargement the use of anticoagulant therapy. Results are expected of long-term follow-up to confirm the benefits of that therapeutic choice.