title: Dabigatran etexilate for secondary stroke prevention: the first year experience from a multicenter short-term registry.
abstract: BACKGROUND
  There are growing concerns for the side effects of dabigatran etexilate (dabigatran), including higher incidence of dyspepsia and gastrointestinal bleeding. We conducted a multicenter early implementation study to prospectively evaluate the safety, efficacy and adherence to dabigatran for secondary stroke prevention.
  
  
  METHODS
  Consecutive atrial fibrillation (AF) patients with ischemic stroke (IS) or transient ischemic attack (TIA) received dabigatran for secondary stroke prevention during their hospital stay according to American Heart Association recommendations at five tertiary care stroke centers. The study population was prospectively followed and outcomes were documented. The primary and secondary safety outcomes were major hemorrhage and all other bleeding events respectively defined according to RE-LY trial methodology.
  
  
  RESULTS
  A total of 78 AF patients (mean age 71 ± 9years; 54% men; 81% IS, 19% TIA; median CHADS2 (Congestive heart failure, Hypertension, diabetes mellitus, age >75 years, prior stroke or TIA); range 2-5) score 4 were treated with dabigatran [(110mg bid (74%); 150mg bid (26%)]. During a mean follow-up period of 7 ± 5 months (range 1-18) we documented no cases of IS, TIA, intracranial hemorrhage, systemic embolism or myocardial infarction in AF patients treated with dabigatran. There were two (2.6%) major bleeding events (lower gastrointestinal bleeding) and two (2.6%) minor bleedings [hematuria (n = 1) and rectal bleeding (n = 1)]. Dabigatran was discontinued in 26% of the study population with high cost being the most common reason for discontinuation (50%).
  
  
  CONCLUSIONS
  Our pilot data indicate that dabigatran appears to be safe for secondary stroke prevention during the first year of implementation of this therapy. However, high cost may limit the long-term treatment of AF patients with dabigatran, leading to early discontinuation.
authors.affiliation: University of Athens, School of Medicine, Iras 39, Gerakas Attikis, Athens, 15344, Greece.
authors.forename: Georgios
authors.initials: G
authors.lastname: Tsivgoulis
authors.affiliation: Department of Neurology, St. Josef-Hospital, Ruhr University, Bochum, Germany.
authors.forename: Christos
authors.initials: C
authors.lastname: Krogias
authors.affiliation: Comprehensive Stroke Center, Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Kara A
authors.initials: KA
authors.lastname: Sands
authors.affiliation: Division of Neurology, Department of Medicine, National University Hospital, and YLL School of Medicine, National University of Singapore, Singapore.
authors.forename: Vijay K
authors.initials: VK
authors.lastname: Sharma
authors.affiliation: Department of Neurology, University of Ioannina, School of Medicine, Ioannina, Greece.
authors.forename: Aristeidis H
authors.initials: AH
authors.lastname: Katsanos
authors.affiliation: Department of Neurology, Democritus University of Thrace, School of Medicine, Alexandroupolis, Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Vadikolias
authors.affiliation: Second Department of Neurology, University of Athens, School of Medicine, Athens, Greece.
authors.forename: Sokratis G
authors.initials: SG
authors.lastname: Papageorgiou
authors.affiliation: Department of Neurology, Democritus University of Thrace, School of Medicine, Alexandroupolis, Greece.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Heliopoulos
authors.affiliation: Comprehensive Stroke Center, Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Harn
authors.initials: H
authors.lastname: Shiue
authors.affiliation: Department of Neurology, Democritus University of Thrace, School of Medicine, Alexandroupolis, Greece.
authors.forename: Athina
authors.initials: A
authors.lastname: Mitsoglou
authors.affiliation: Second Department of Neurology, University of Athens, School of Medicine, Athens, Greece.
authors.forename: Chrissoula
authors.initials: C
authors.lastname: Liantinioti
authors.affiliation: Vascular Unit, Third Department of Surgery, School of Medicine, University of Athens, School of Medicine, Athens, Greece.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Athanasiadis
authors.affiliation: Department of Neurology, University of Ioannina, School of Medicine, Ioannina, Greece.
authors.forename: Sotirios
authors.initials: S
authors.lastname: Giannopoulos
authors.affiliation: Department of Neurology, Democritus University of Thrace, School of Medicine, Alexandroupolis, Greece.
authors.forename: Charitomeni
authors.initials: C
authors.lastname: Piperidou
authors.affiliation: Second Department of Neurology, University of Athens, School of Medicine, Athens, Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Voumvourakis
authors.affiliation: Department of Neurology, Democritus University of Thrace, School of Medicine, Alexandroupolis, Greece.
authors.forename: Andrei V
authors.initials: AV
authors.lastname: Alexandrov
keywords: atrial fibrillation; dabigatran etexilate; secondary prevention; stroke; transient ischemic attack