Perioperative Management of Direct Oral Anticoagulants in Patients having a High-Bleed-Risk Surgery or Neuraxial Procedure: The PAUSE-2 Pilot Randomized Trial.

Abstract

Background: There is uncertainty about the perioperative management of patients who are receiving a direct oral anticoagulant (DOAC) and require an elective high-bleed-risk surgery, including those who are undergoing a neuraxial or deep peripheral nerve block procedure.

Methods: The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE)-2 pilot trial was a proof-of-concept, open-label, randomized controlled trial that assessed the feasibility of comparing perioperative DOAC management using an American Society of Regional Anesthesia (ASRA)-based or PAUSE-based approach in patients with atrial fibrillation who needed an elective high-bleed-risk surgery/procedure and/or any neuraxial anesthesia/procedure.

Results: There were 159 patients enrolled (86 on apixaban, 12 on dabigatran, and 61 on rivaroxaban), of whom 141 had pre-operative DOAC level testing done. The median (IQR) residual DOAC level was 19 (19-24) ng/mL in the ASRA group, and 20 (19-24) ng/mL in the PAUSE group (standardized difference=-0.02). The percentage of patients in the ASRA and PAUSE groups with pre-operative residual DOAC levels <30 ng/mL was 95.6% and 94.4%; the percentage with residual DOAC levels 30-50 ng/mL was 1.4% and 2.8%, and the percentage with levels >50 ng/mL was 2.9% and 2.8%.

Conclusion: In this pilot trial, we found that recruitment of DOAC-treated patients who needed an elective high-bleed-risk surgery or neuraxial procedure was feasible and that pre-operative residual DOAC levels appeared similar according to ASRA-based and PAUSE-based management approaches, providing the foundation for a larger trial comparing ASRA- and PAUSE-based perioperative DOAC management.