title: The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study.
abstract: BACKGROUND
  During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses.
  
  
  RESULTS
  Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04-1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y.
  
  
  CONCLUSIONS
  During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death.
authors.affiliation: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.connostu@phri.ca
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
authors.forename: Michael D
authors.initials: MD
authors.lastname: Ezekowitz
authors.forename: John
authors.initials: J
authors.lastname: Eikelboom
authors.forename: Jonas
authors.initials: J
authors.lastname: Oldgren
authors.forename: Paul A
authors.initials: PA
authors.lastname: Reilly
authors.forename: Martina
authors.initials: M
authors.lastname: Brueckmann
authors.forename: Janice
authors.initials: J
authors.lastname: Pogue
authors.forename: Marco
authors.initials: M
authors.lastname: Alings
authors.forename: John V
authors.initials: JV
authors.lastname: Amerena
authors.forename: Alvaro
authors.initials: A
authors.lastname: Avezum
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.forename: Andrzej J
authors.initials: AJ
authors.lastname: Budaj
authors.forename: Jyh-Hong
authors.initials: JH
authors.lastname: Chen
authors.forename: Antonio L
authors.initials: AL
authors.lastname: Dans
authors.forename: Harald
authors.initials: H
authors.lastname: Darius
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Pasquale
authors.forename: Jorge
authors.initials: J
authors.lastname: Ferreira
authors.forename: Greg C
authors.initials: GC
authors.lastname: Flaker
authors.forename: Marcus D
authors.initials: MD
authors.lastname: Flather
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Franzosi
authors.forename: Sergey P
authors.initials: SP
authors.lastname: Golitsyn
authors.forename: David A
authors.initials: DA
authors.lastname: Halon
authors.forename: Hein
authors.initials: H
authors.lastname: Heidbuchel
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.forename: Petr
authors.initials: P
authors.lastname: Jansky
authors.forename: Gabriel
authors.initials: G
authors.lastname: Kamensky
authors.forename: Matyas
authors.initials: M
authors.lastname: Keltai
authors.forename: Sung Soon
authors.initials: SS
authors.lastname: Kim
authors.forename: Chu-Pak
authors.initials: CP
authors.lastname: Lau
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Le Heuzey
authors.forename: Basil S
authors.initials: BS
authors.lastname: Lewis
authors.forename: Lisheng
authors.initials: L
authors.lastname: Liu
authors.forename: John
authors.initials: J
authors.lastname: Nanas
authors.forename: Razali
authors.initials: R
authors.lastname: Omar
authors.forename: Prem
authors.initials: P
authors.lastname: Pais
authors.forename: Knud E
authors.initials: KE
authors.lastname: Pedersen
authors.forename: Leopoldo S
authors.initials: LS
authors.lastname: Piegas
authors.forename: Dimitar
authors.initials: D
authors.lastname: Raev
authors.forename: Pal J
authors.initials: PJ
authors.lastname: Smith
authors.forename: Mario
authors.initials: M
authors.lastname: Talajic
authors.forename: Ru San
authors.initials: RS
authors.lastname: Tan
authors.forename: Supachai
authors.initials: S
authors.lastname: Tanomsup
authors.forename: Lauri
authors.initials: L
authors.lastname: Toivonen
authors.forename: Dragos
authors.initials: D
authors.lastname: Vinereanu
authors.forename: Denis
authors.initials: D
authors.lastname: Xavier
authors.forename: Jun
authors.initials: J
authors.lastname: Zhu
authors.forename: Susan Q
authors.initials: SQ
authors.lastname: Wang
authors.forename: Christine O
authors.initials: CO
authors.lastname: Duffy
authors.forename: Ellison
authors.initials: E
authors.lastname: Themeles
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000991:Antithrombins / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000401:mortality; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D000069604:Dabigatran; D004305:Dose-Response Relationship, Drug; D004617:Embolism / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced / Q000401:mortality; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome; D015091:beta-Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D000069604:Dabigatran
keywords: atrial fibrillation; dabigatran; hemorrhage; stroke