Sam Schulman1, Marc Carrier2, Agnes Y Y Lee2, Sudeep Shivakumar2, Mark Blostein2, Frederick A Spencer2, Susan Solymoss2, Rebecca Barty2, Grace Wang2, Nancy Heddle2, James D Douketis2. 1. 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. 2. 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.).
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. METHODS AND 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. CONCLUSION: Our protocol for perioperative management of dabigatran appears to be effective and feasible.
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. METHODS AND 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. CONCLUSION: Our protocol for perioperative management of dabigatran appears to be effective and feasible.
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