Perioperative management of direct oral anticoagulants in patients having a high-bleed-risk surgery or neuraxial procedure: the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE)-2 pilot randomized trial

BACKGROUND: There is uncertainty about the perioperative management of patients who are receiving a direct oral anticoagulant (DOAC) and require elective high-bleed-risk surgery, including those who are undergoing a neuraxial or deep peripheral nerve block procedure. OBJECTIVES: The objectives of this pilot trial were to provide preliminary data as to pre-operative residual DOAC levels with different management strategies andro assess the feasibility of a larger trial. 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 preoperative 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 preoperative residual DOAC levels < 30 ng/mL was 95.6% and 94.4%, respectively; the percentage with residual DOAC levels of 30 to 50 ng/mL was 1.4% and 2.8%, respectively, and the percentage with levels > 50 ng/mL was 2.9% and 2.8%, respectively. 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 preoperative 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.