Urgent surgery or procedures in patients taking dabigatran or warfarin: Analysis of perioperative outcomes from the RE-LY trial

Thromb Res. 2016 Mar:139:77-81. doi: 10.1016/j.thromres.2016.01.004. Epub 2016 Jan 9.

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).

Conclusion: 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.

Keywords: Dabigatran; Perioperative; Urgent surgery; Warfarin.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Ambulatory Care*
  • Anticoagulants / adverse effects*
  • Anticoagulants / therapeutic use
  • Dabigatran / adverse effects*
  • Dabigatran / therapeutic use
  • Female
  • Hemorrhage / chemically induced*
  • Hemorrhage / complications
  • Humans
  • Male
  • Perioperative Period
  • Surgical Procedures, Operative* / adverse effects
  • Surgical Procedures, Operative* / mortality
  • Thromboembolism / chemically induced*
  • Thromboembolism / complications
  • Warfarin / adverse effects*
  • Warfarin / therapeutic use

Substances

  • Anticoagulants
  • Warfarin
  • Dabigatran