Randomized, sham-controlled trial of intraoperative ticagrelor removal to reduce perioperative bleeding

OBJECTIVE: Patients on ticagrelor who are undergoing cardiac surgery before completing guideline-recommended washout are at high risk for severe bleeding. This study evaluated whether a novel drug removal device reduces bleeding in patients operated within 2 days from ticagrelor discontinuation. METHODS: Eligible patients were randomized 1:1 to intraoperative DrugSorb-ATR or sham control. Primary safety end point was adverse events at 30 days. Efficacy was assessed by composite end points comprising bleeding events using Universal Definition of Perioperative Bleeding (UDPB) and 24-hour chest tube drainage (CTD) in the overall and isolated coronary artery bypass grafting (CABG) populations with a hierarchical win ratio (WR) method. RESULTS: In total, 140 patients were randomized; 132 had surgery and received a study device; and 92% were isolated CABG. Mean age was 65 ± 5 years, and 15% were female. The primary safety end point was met, with similar adverse events reported between groups. The primary efficacy end point was not met in the overall or CABG populations (Win ratio [WR], 1.07; 95% CI, 0.72-1.58; P = .748 and WR, 1.33; 95% CI, 0.86-2.04; P = .202 respectively). The supplementary efficacy end point was met in the CABG population (WR, 1.59; 95% CI, 1.02-2.46, P = .041) with significant reductions also shown in large CTD bleeding events (P = .016) and major bleeding, a composite of severe bleeding events or 24-hour CTD ≥1 L (P = .041). The number needed to treat to prevent a major bleed was 6. CONCLUSIONS: Intraoperative use of DrugSorb-ATR is safe in patients operated within 2 days of ticagrelor discontinuation. Although the primary end point was not met in the overall population, there were significant reductions in severe bleeding events in the prespecified CABG population.