Intraoperative Removal of Direct Oral Anticoagulants in Patients Undergoing Urgent Cardiac Surgery

BACKGROUND Urgent cardiac surgery on direct oral anticoagulants is associated with high rates of severe bleeding and increased mortality. Since DOAC reversal is not recommended during cardiopulmonary bypass (CPB), intraoperative DOAC removal with a hemoadsorption device may be an alternate approach to lower circulating DOAC levels. METHODS Double-blind, sham-controlled, randomized trial in patients undergoing urgent on-pump cardiac surgery within 36 hours of last DOAC dose. Randomization 1:1 between DrugSorb-ATR device and sham. Primary endpoint was fatal, moderate, severe, or massive bleeding per Universal Definition for Perioperative Bleeding and 24-hr chest tube drainage. Key secondary endpoint was percent DOAC level reduction between pre-CPB and post-CPB samples. Safety was assessed by an independent data safety and monitoring board, and study follow-up was 30 days. RESULTS Of 120 planned subjects, only 9 were enrolled (study stopped early). Six subjects on apixaban and three on rivaroxaban were operated at a mean 29.5±10.4 hours since last dose. Mean CPB duration was 147±76.5 min. Due to the limited sample size, only DOAC levels were analyzed. Drugsorb-ATR significantly reduced DOAC levels compared with control (62.21±8.9% vs. 27.95±8.6%, p=0.02). Among 6 patients with pre-CPB DOAC levels >30 ng/mL, all 3 treated with the device dropped below 30 ng/mL at the end of CPB, compared with none of 3 controls. CONCLUSIONS Intraoperative use of a novel device significantly reduces DOAC levels. Further studies are needed to determine whether DOAC level reductions translate to reduced bleeding.