title: Perioperative Management of Dabigatran: A Prospective Cohort Study.
abstract: BACKGROUND
  The perioperative management of dabigatran in clinical practice is heterogeneous. We performed this study to evaluate the safety of perioperative management of dabigatran using a specified protocol.
  
  
  RESULTS
  Patients treated with dabigatran and planned for an invasive procedure were eligible for inclusion. The timing of the last dose of dabigatran before the procedure was based on the creatinine clearance and procedure-related bleeding risk. Resumption of dabigatran was prespecified according to the complexity of the surgery and consequences of a bleeding complication. Patients were followed up for 30 days for major bleeding (primary outcome), minor bleeding, arterial thromboembolism, and death. We included 541 cases: 324 procedures (60%) with standard risk of bleeding and 217 procedures (40%) with increased risk of bleeding. The last dose of dabigatran was at 24, 48, or 96 hours before surgery according to the protocol in 46%, 37%, and 6%, respectively, of the patients. Resumption was timed according to protocol in 77% with 75 mg as the first dose on the day of procedure in 40% of the patients. Ten patients (1.8%; 95% confidence interval, 0.7-3.0) had major bleeding, and 28 patients (5.2%; 95% confidence interval, 3.3-7.0) had minor bleeding events. The only thromboembolic complication was transient ischemic attack in 1 patient (0.2%; 95% confidence interval, 0-0.5), and there were 4 deaths unrelated to bleeding or thrombosis. Bridging was not used preoperatively but was administered in 9 patients (1.7%) postoperatively.
  
  
  CONCLUSIONS
  Our protocol for perioperative management of dabigatran appears to be effective and feasible.
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.). schulms@mcmaster.ca.
authors.forename: Sam
authors.initials: S
authors.lastname: Schulman
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Marc
authors.initials: M
authors.lastname: Carrier
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Agnes Y Y
authors.initials: AY
authors.lastname: Lee
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Sudeep
authors.initials: S
authors.lastname: Shivakumar
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Mark
authors.initials: M
authors.lastname: Blostein
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Frederick A
authors.initials: FA
authors.lastname: Spencer
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Susan
authors.initials: S
authors.lastname: Solymoss
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Rebecca
authors.initials: R
authors.lastname: Barty
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Grace
authors.initials: G
authors.lastname: Wang
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: Nancy
authors.initials: N
authors.lastname: Heddle
authors.affiliation: From Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, F.A.S., J.D.D.); Department of Hematology, Karolinska Institutet, Stockholm, Sweden (S. Schulman); Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, ON, Canada (M.C.); Division of Hematology, University of British Columbia and Vancouver Coastal Health, Canada (A.Y.Y.L.); Faculty of Medicine, Dalhousie University, Halifax, NS, Canada (S. Shivakumar); Division of Hematology, Department of Medicine, Jewish General Hospital (M.B.) and Department of Medicine (S. Solymoss), McGill University, Montreal, QC, Canada; and McMaster Transfusion Research Program, McMaster University, Hamilton, ON, Canada (R.B., G.W., N.H.).
authors.forename: James D
authors.initials: JD
authors.lastname: Douketis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood*; D015331:Cohort Studies; D000069604:Dabigatran; D019468:Disease Management; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods*; D011446:Prospective Studies; D013923:Thromboembolism / Q000097:blood / Q000517:prevention & control; D015091:beta-Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D000069604:Dabigatran
keywords: dabigatran; hemorrhage; medication adherence; surgery