title: Urgent surgery or procedures in patients taking dabigatran or warfarin: Analysis of perioperative outcomes from the RE-LY trial.
abstract: BACKGROUND
  There is concern about the management of anticoagulated patients with atrial fibrillation (AF) who require an urgent surgery/procedure, especially in those who are receiving a direct oral anticoagulant such as dabigatran.
  
  
  METHODS
  We accessed the database from RE-LY, a randomized trial comparing dabigatran (110mg and 150mg twice daily) with warfarin for stroke prevention in AF, to assess patients who had an urgent and elective surgery/procedure. We compared the risk for thromboembolism, major bleeding and mortality according to treatment allocation (dabigatran 110mg or 150mg, or warfarin) or surgery/procedure type (urgent or elective). Outcomes were assessed from day-7 to day 30 after a surgery/procedure.
  
  
  RESULTS
  353 patients (2.0% of study population) had an urgent surgery/procedure and 4168 patients (23.1% of study population) had an elective surgery/procedure. In patients on dabigatran 110mg, dabigatran 150mg and warfarin who had an urgent surgery/procedure: rates of thromboembolism were 16.1%, 7.4%, and 10.5%; rates of major bleeding were 17.0%, 17.6%, and 22.9%; rates of mortality were 6.3%, 1.5%, and 2.9%, respectively (P>0.50 for all comparisons). Rates of these outcomes were multi-fold higher in patients having an urgent rather than an elective surgery/procedure (P<0.5 for all comparisons).
  
  
  CONCLUSIONS
  In anticoagulated patients with atrial fibrillation who require an urgent surgery/procedure, the risks for thromboembolism, major bleeding and mortality did not differ depending on treatment with dabigatran or warfarin, but rates of these outcomes were multi-fold higher than in patients having an elective surgery/procedure.
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Canada. Electronic address: jdouket@mcmaster.ca.
authors.forename: James D
authors.initials: JD
authors.lastname: Douketis
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Canada; Population Health Research Institute, McMaster University, Hamilton, Canada.
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co, Ingelheim am Rhein, Germany; Medical Faculty, Mannheim University of Heidelberg, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Brueckmann
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co, Ingelheim am Rhein, Germany.
authors.forename: Mandy
authors.initials: M
authors.lastname: Fraessdorf
authors.affiliation: Hofstra North Shore-Long Island Jewish School of Medicine, Manhasset, NY, USA.
authors.forename: Alex C
authors.initials: AC
authors.lastname: Spyropoulos
authors.affiliation: Uppsala Clinical Research Centre and Department of Medical Sciences Cardiology, Uppsala University, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
authors.affiliation: Uppsala Clinical Research Centre and Department of Medical Sciences Cardiology, Uppsala University, Sweden.
authors.forename: Jonas
authors.initials: J
authors.lastname: Oldgren
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Reilly
authors.affiliation: Jefferson Medical College, Wynnewood, PA, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Ezekowitz
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Canada; Population Health Research Institute, McMaster University, Hamilton, Canada.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Connolly
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Canada; Population Health Research Institute, McMaster University, Hamilton, Canada.
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Canada; Population Health Research Institute, McMaster University, Hamilton, Canada.
authors.forename: John W
authors.initials: JW
authors.lastname: Eikelboom
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use; D000069604:Dabigatran / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000150:complications; D006801:Humans; D008297:Male; D059035:Perioperative Period; D013514:Surgical Procedures, Operative / Q000009:adverse effects / Q000401:mortality; D013923:Thromboembolism / Q000139:chemically induced* / Q000150:complications; D014859:Warfarin / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D000069604:Dabigatran
keywords: Dabigatran; Perioperative; Urgent surgery; Warfarin