Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES Study

Background: Little evidence is available on the long-term efficacy and safety of edoxaban, mainly due to the recent release date. The primary objective of the study was to evaluate the safety of edoxaban, defined by the incidence of major bleedings. We then aimed to evaluate the incidence of thrombo...

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Main Authors: Irene Scala, Simone Bellavia, Pier Andrea Rizzo, Jacopo Di Giovanni, Mauro Monforte, Roberta Morosetti, Giacomo Della Marca, Fabio Pilato, Aldobrando Broccolini, Paolo Profice, Giovanni Frisullo
Format: Article
Language:English
Published: MDPI AG 2023-11-01
Series:Brain Sciences
Subjects:
Online Access:https://www.mdpi.com/2076-3425/13/11/1541
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author Irene Scala
Simone Bellavia
Pier Andrea Rizzo
Jacopo Di Giovanni
Mauro Monforte
Roberta Morosetti
Giacomo Della Marca
Fabio Pilato
Aldobrando Broccolini
Paolo Profice
Giovanni Frisullo
author_facet Irene Scala
Simone Bellavia
Pier Andrea Rizzo
Jacopo Di Giovanni
Mauro Monforte
Roberta Morosetti
Giacomo Della Marca
Fabio Pilato
Aldobrando Broccolini
Paolo Profice
Giovanni Frisullo
author_sort Irene Scala
collection DOAJ
description Background: Little evidence is available on the long-term efficacy and safety of edoxaban, mainly due to the recent release date. The primary objective of the study was to evaluate the safety of edoxaban, defined by the incidence of major bleedings. We then aimed to evaluate the incidence of thromboembolic events and the persistence of edoxaban therapy in the long-term. Methods: In this observational cohort study, we included ischemic stroke patients enrolled in a previous study to evaluate the safety and efficacy of long-term edoxaban treatment. Data were collected by a trained investigator through a structured telephone interview. Results: Sixty-three subjects (median age 81.0 (73.5–88.0) years, 38.1% male) were included in the study, with a mean follow-up of 4.4 ± 0.7 years (range: 3.2–5.5 years). Only one patient (1.6%, 0.4%/year) presented a major extracranial bleeding, and none had cerebral hemorrhage. Six thromboembolic events occurred in five patients (7.9%): three recurrent strokes, two transient ischemic attacks, and one myocardial infarction (2.2%/year). Over a follow-up period of more than three years, 13 patients discontinued edoxaban (20.6%). <b>Conclusions:</b> Edoxaban seems to be effective and safe in the long-term. The persistence rate of edoxaban therapy is optimal after more than three years of treatment.
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spelling doaj.art-f755b5fc55c94be48afd8ca1cc4282612023-11-24T14:32:40ZengMDPI AGBrain Sciences2076-34252023-11-011311154110.3390/brainsci13111541Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES StudyIrene Scala0Simone Bellavia1Pier Andrea Rizzo2Jacopo Di Giovanni3Mauro Monforte4Roberta Morosetti5Giacomo Della Marca6Fabio Pilato7Aldobrando Broccolini8Paolo Profice9Giovanni Frisullo10School of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, ItalySchool of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, ItalySchool of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, ItalySchool of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, ItalyDepartment of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, ItalyDepartment of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, ItalySchool of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, ItalyNeurology, Neurophysiology and Neurobiology Unit, Department of Medicine, Fondazione Campus Bio-Medico di Roma, 00128 Rome, ItalySchool of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, ItalyUOC Neurologia and Stroke Unit, Mater Olbia Hospital, 07026 Olbia, ItalyDepartment of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, ItalyBackground: Little evidence is available on the long-term efficacy and safety of edoxaban, mainly due to the recent release date. The primary objective of the study was to evaluate the safety of edoxaban, defined by the incidence of major bleedings. We then aimed to evaluate the incidence of thromboembolic events and the persistence of edoxaban therapy in the long-term. Methods: In this observational cohort study, we included ischemic stroke patients enrolled in a previous study to evaluate the safety and efficacy of long-term edoxaban treatment. Data were collected by a trained investigator through a structured telephone interview. Results: Sixty-three subjects (median age 81.0 (73.5–88.0) years, 38.1% male) were included in the study, with a mean follow-up of 4.4 ± 0.7 years (range: 3.2–5.5 years). Only one patient (1.6%, 0.4%/year) presented a major extracranial bleeding, and none had cerebral hemorrhage. Six thromboembolic events occurred in five patients (7.9%): three recurrent strokes, two transient ischemic attacks, and one myocardial infarction (2.2%/year). Over a follow-up period of more than three years, 13 patients discontinued edoxaban (20.6%). <b>Conclusions:</b> Edoxaban seems to be effective and safe in the long-term. The persistence rate of edoxaban therapy is optimal after more than three years of treatment.https://www.mdpi.com/2076-3425/13/11/1541NOACsDOACsedoxabanatrial fibrillationstrokecardioembolism
spellingShingle Irene Scala
Simone Bellavia
Pier Andrea Rizzo
Jacopo Di Giovanni
Mauro Monforte
Roberta Morosetti
Giacomo Della Marca
Fabio Pilato
Aldobrando Broccolini
Paolo Profice
Giovanni Frisullo
Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES Study
Brain Sciences
NOACs
DOACs
edoxaban
atrial fibrillation
stroke
cardioembolism
title Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES Study
title_full Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES Study
title_fullStr Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES Study
title_full_unstemmed Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES Study
title_short Prolonged Secondary Stroke Prevention with Edoxaban: A Long-Term Follow-Up of the SATES Study
title_sort prolonged secondary stroke prevention with edoxaban a long term follow up of the sates study
topic NOACs
DOACs
edoxaban
atrial fibrillation
stroke
cardioembolism
url https://www.mdpi.com/2076-3425/13/11/1541
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