Key result
Intraoperative hemoadsorption is associated with a low ~5% severe bleeding rate in DOAC patients undergoing CABG.
Why the study?
Patients on direct-acting oral anticoagulants undergoing non-deferable cardiac surgery are at high risk of perioperative bleeding, and intraoperative hemoadsorption is a novel strategy to reduce this risk.
Does intraoperative hemoadsorption reduce perioperative bleeding in patients on DOACs undergoing non-deferable CABG and/or single valve surgery?
Observational (n=62)
Yes
Does intraoperative hemoadsorption reduce perioperative bleeding in patients on DOACs undergoing non-deferable CABG and/or single valve surgery?
Intraoperative hemoadsorption during non-deferable cardiac surgery in patients on DOACs is associated with low rates of severe perioperative bleeding.
May support hemoadsorption to mitigate bleeding in urgent DOAC cardiac surgery; leaves open efficacy confirmation in randomized trials.
OBJECTIVE: Patients on direct-acting oral anticoagulants (DOACs) are at high risk of perioperative bleeding complications. Intraoperative hemoadsorption is a novel strategy to reduce perioperative bleeding in patients on DOACs undergoing non-deferable cardiac surgery. The international STAR-registry reports real-world clinical outcomes associated with this application. METHODS: The hemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit and active for the duration of the pump run. Patients on DOACs undergoing CABG and/or single valve surgery before completing the recommended washout were included. Outcome measurements included bleeding events according to standardized definitions and 24-hour chest-tube-drainage (CTD). RESULTS: A total of 62 patients were included from 7 institutions in Austria, Germany, Sweden, and the UK (mean age 69.9 ± 7.5years, 71% male). Approximately half were on apixaban and the other half was split between rivaroxaban and edoxaban with 21% of patients also on aspirin. Surgery occurred at a median time of 28.9 h since the last DOAC dose with single valve surgery accounting for 2/3 of cases. Mean CPB duration was 118.6 ± 46.4 min. Severe bleeding (UDPB ≥ 3) occurred in 4.8%, and BARC-4 bleeding occurred in 3.2% of the patients. Only one patient (1.6%) required reoperation for bleeding control. The mean 24-hour CTD was 771.3 ± 482.79mL. No device-related adverse events were reported. CONCLUSIONS: This interim report of the ongoing STAR-registry shows that, in patients on DOAC undergoing non-deferable CABG and/or single valve surgery, the use of intraoperative hemoadsorption is associated with low rates of severe perioperative bleeding complications. Further prospective studies in larger cohorts are needed to validate the efficacy of this method. CLINICAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT05077124.
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Schmoeckel et al. (2025) conducted an observational in Patients on DOACs requiring non-deferable cardiac surgery (n=62). Intraoperative hemoadsorption (CytoSorb) was evaluated on Severe bleeding (UDPB ≥ 3). Intraoperative hemoadsorption in patients on DOACs undergoing non-deferable CABG and/or single valve surgery resulted in low rates of severe bleeding, with UDPB ≥ 3 occurring in 4.8% of patients.
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