Perioperative Management of Dabigatran | Journal Scan
How safe is perioperative management of dabigatran using a protocol based on renal function and drug pharmacokinetics?
This was an observational study that included patients treated with dabigatran and planned for an invasive procedure. 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 also prespecified and was determined by 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. High-risk surgeries included cardiac surgery, neurosurgery, abdominal surgery, or those involving a major organ or where complete hemostasis may be required. Other factors such as spinal anesthesia and other determinants of bleeding risk including advancing age, comorbidities (e.g., major cardiac, respiratory or liver disease), and concomitant use of antiplatelet therapy were also considered.
The study population included 541 cases, of whom 324 procedures (60%) had standard risk of bleeding and 217 (40%) were at 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 cases. Bridging was not used preoperatively, but was administered in nine cases (1.7%) postoperatively. Resumption was timed according to protocol in 77% of cases, and a dose of 75 mg was used on the day of the procedure in 40% of the cases. Major bleeding was seen in 10 patients (1.8%; 95% confidence interval [CI], 0.7-3.0), and 28 patients (5.2%; 95% CI, 3.3-7.0) had minor bleeding events. The only thromboembolic complication was transient ischemic attack in one case (0.2%; 95% CI, 0-0.5). There were four deaths, but they were all unrelated to bleeding or thrombosis.
Perioperative management of dabigatran using a protocol that takes into account the bleeding risk and renal function is associated with an excellent clinical outcome.
The authors developed and implemented a protocol for perioperative management of dabigatran that takes into account the baseline renal function and the risk of the planned surgery, and achieved remarkable safety with such an approach. Given the increasing use of dabigatran and factor Xa inhibitors in clinical practice, all institutions need to have a clear policy to guide the perioperative management of these agents. The protocol described in this study is simple and would be easy to replicate at any institution, and should serve as a template for safe and effective perioperative management of novel oral anticoagulants.
Keywords: Anesthesia, Spinal, Anticoagulants, Benzimidazoles, beta-Alanine, Cardiac Surgical Procedures, Creatinine, Comorbidity, Factor Xa Inhibitors, Hemostasis, Ischemic Attack, Transient, Liver Diseases, Neurosurgery, Perioperative Period, Postoperative Period, Preoperative Period, Thromboembolism, Thrombosis
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