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Título

A BRAZILIAN OBSERVATIONAL STUDY OF EDOXABAN IN ATRIAL FIBRILLATION PATIENTS (EDOBRA STUDY)

Resumo

Background and Rationale: Atrial fibrillation (AF) is the most common type of arrhythmia, and it is estimated to affect 2.5% of the Brazilian population. Atrial fibrillation increases the risk of cardioembolic stroke, death and is therefore associated with increased morbimortality. Non-Vitamin K oral anticoagulants (NOACs) have been available in Brazil and since 2018 edoxaban has been added to the therapeutic arsenal. To understand the risks and benefits of edoxaban use in a real-world clinical setting in the non-Valvular Atrial Fibrillation (NVAF) indication, the current study aimed to evaluate the effectiveness and safety of edoxaban in patients with NVAF and indication for oral anticoagulation. Methods:  Multi-center, prospective, observational study conducted in Brazil. Principal Investigators may not include patients to whom they have prescribed edoxaban, patients referred from other physicians are eligible. It was planned 700 patients treated with edoxaban. Eligible patients are those ≥ 18 years diagnosed with NVAF who initiated edoxaban treatment for at least 14 days and no longer than 90 days prior to enrollment. There were no recommendations to change routine clinical practice. The primary objective was to evaluate the safety of edoxaban in a regular clinical care setting in regards the occurrence of ISTH (International Society of Thrombosis and Haemostasis) Clinically Relevant Bleeding during 1 year of follow-up. Results: 713 patients from 30 Brazilian sites were screened and the full analysis set corresponds to 590 patients, who received edoxaban and had at least one follow-up visit, or one event reported. Most of patients (60%) were men and median age was 70 years. The most common comorbidities at baseline were arterial hypertension (78.39%), dyslipidemia (41.85%), diabetes (29.7%) and heart failure (27.79%). The median of CHA2DS2-VASc Risk Score was 3 and the median of HAS-BLED Risk Score was 2 (Table 1). During the 1-year follow-up period, 4 stroke events were reported (0,68%) and 3 events classified as ischemic stroke. Regarding bleeding events, 13 ISTH clinically relevant bleeding were reported (2,2%) and 9 of them classified as major bleeding (5 gastrointestinal bleeding, 1 intramuscular with compartment syndrome and 3 as others). Most events were classified as spontaneous by Investigators (6) and 2 GI bleedings resulted in death. No Intracranial bleeding of hemorrhagic stroke was reported during one year of follow-up (Table 2 and Figure 1). Conclusions: EdoBRA study provides valuable insights into the safety profile of edoxaban in a Brazilian population with NVAF. Overall, in this real-world population, the incidence of stroke and major bleeding were low, indicating the effectiveness and the safety of edoxaban treating NVAF patients.

Palavras Chave

Edoxaban; Oral anticoagulant; Atrial Fibrillation