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

DOACs NOACs NVAF anticoagulants atrial fibrillation cardioembolism edoxaban stroke

Journal

Brain sciences
ISSN: 2076-3425
Titre abrégé: Brain Sci
Pays: Switzerland
ID NLM: 101598646

Informations de publication

Date de publication:
02 Nov 2023
Historique:
received: 25 09 2023
revised: 30 10 2023
accepted: 31 10 2023
medline: 25 11 2023
pubmed: 25 11 2023
entrez: 25 11 2023
Statut: epublish

Résumé

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. 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. 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%).

Sections du résumé

BACKGROUND 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 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 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%).

Identifiants

pubmed: 38002501
pii: brainsci13111541
doi: 10.3390/brainsci13111541
pmc: PMC10669805
pii:
doi:

Types de publication

Journal Article

Langues

eng

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Auteurs

Irene Scala (I)

School of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, Italy.
Department of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.

Simone Bellavia (S)

School of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, Italy.

Pier Andrea Rizzo (PA)

School of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, Italy.

Jacopo Di Giovanni (J)

School of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, Italy.

Mauro Monforte (M)

Department of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.

Roberta Morosetti (R)

Department of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.

Giacomo Della Marca (GD)

School of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, Italy.
Department of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.

Fabio Pilato (F)

Neurology, Neurophysiology and Neurobiology Unit, Department of Medicine, Fondazione Campus Bio-Medico di Roma, 00128 Rome, Italy.

Aldobrando Broccolini (A)

School of Medicine and Surgery, Catholic University of Sacred Heart, Largo Francesco Vito, 1, 00168 Rome, Italy.
Department of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.

Paolo Profice (P)

UOC Neurologia and Stroke Unit, Mater Olbia Hospital, 07026 Olbia, Italy.

Giovanni Frisullo (G)

Department of Neurosciences, Sense Organs and Thorax, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.

Classifications MeSH