Perioperative Management of Dabigatran: A Prospective Cohort Study

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 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 h before surgery according to the protocol in 46%, 37% and 6%, respectively, of the cases. Resumption was timed according to protocol in 77% with 75 mg as the first dose on the day of procedure in 40% of the cases. Ten patients (1.8%; 95% confidence interval [CI], 0.7-3.0) had major bleeding and 28 patients (5.2%; 95% CI, 3.3-7.0) had minor bleeding events. The only thromboembolic complication was transient ischemic attack in 1 case (0.2%; 95% CI, 0-0.5), and there were 4 deaths unrelated to bleeding or thrombosis. Bridging was not used preoperatively but was administered in 9 cases (1.7%) postoperatively. Conclusions —Our protocol for perioperative management of dabigatran appears effective and feasible.