title: Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion.
abstract: BACKGROUND
  The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial compared dabigatran 110 mg BID (D110) and 150 mg BID (D150) with warfarin for stroke prevention in 18 113 patients with nonvalvular atrial fibrillation.
  
  
  RESULTS
  Cardioversion on randomized treatment was permitted. Precardioversion transesophageal echocardiography was encouraged, particularly in dabigatran-assigned patients. Data from before, during, and 30 days after cardioversion were analyzed. A total of 1983 cardioversions were performed in 1270 patients: 647, 672, and 664 in the D110, D150, and warfarin groups, respectively. For D110, D150, and warfarin, transesophageal echocardiography was performed before 25.5%, 24.1%, and 13.3% of cardioversions, of which 1.8%, 1.2%, and 1.1% were positive for left atrial thrombi. Continuous treatment with study drug for ≥3 weeks before cardioversion was lower in D110 (76.4%) and D150 (79.2%) compared with warfarin (85.5%; P<0.01 for both). Stroke and systemic embolism rates at 30 days were 0.8%, 0.3%, and 0.6% (D110 versus warfarin, P=0.71; D150 versus warfarin, P=0.40) and similar in patients with and without transesophageal echocardiography. Major bleeding rates were 1.7%, 0.6%, and 0.6% (D110 versus warfarin, P=0.06; D150 versus warfarin, P=0.99).
  
  
  CONCLUSIONS
  This study is the largest cardioversion experience to date and the first to evaluate a novel anticoagulant in this setting. The frequencies of stroke and major bleeding within 30 days of cardioversion on the 2 doses of dabigatran were low and comparable to those on warfarin with or without transesophageal echocardiography guidance. Dabigatran is a reasonable alternative to warfarin in patients requiring cardioversion.
authors.affiliation: Louisiana State University School of Medicine, New Orleans, LA, USA.
authors.forename: Rangadham
authors.initials: R
authors.lastname: Nagarakanti
authors.forename: Michael D
authors.initials: MD
authors.lastname: Ezekowitz
authors.forename: Jonas
authors.initials: J
authors.lastname: Oldgren
authors.forename: Sean
authors.initials: S
authors.lastname: Yang
authors.forename: Michael
authors.initials: M
authors.lastname: Chernick
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Aikens
authors.forename: Greg
authors.initials: G
authors.lastname: Flaker
authors.forename: Josep
authors.initials: J
authors.lastname: Brugada
authors.forename: Gabriel
authors.initials: G
authors.lastname: Kamensky
authors.forename: Amit
authors.initials: A
authors.lastname: Parekh
authors.forename: Paul A
authors.initials: PA
authors.lastname: Reilly
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000503:physiopathology / Q000628:therapy*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000069604:Dabigatran; D017548:Echocardiography, Transesophageal; D004554:Electric Countershock; D004599:Electric Stimulation Therapy; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D012189:Retrospective Studies; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control*; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D015091:beta-Alanine; D014859:Warfarin; D000069604:Dabigatran