The DrugSorb-ATR device significantly reduced unbound ticagrelor and active metabolite levels, lowering the risk of clinically relevant bleeding in cardiac surgery patients.
Does the intraoperative use of the DrugSorb-ATR device reduce unbound ticagrelor and TAM concentrations and bleeding complications in patients undergoing CT surgery within 2 days of ticagrelor discontinuation?
Intraoperative use of the DrugSorb-ATR device effectively removes unbound ticagrelor and its active metabolite, potentially reducing perioperative bleeding in patients requiring urgent cardiac surgery.
Tasa de eventos absoluta: 0% vs 0%
Abstract: Excessive surgical bleeding is a potential risk in patients taking ticagrelor who must undergo urgent cardiothoracic (CT) surgery before adequate washout of the drug can occur. The DrugSorb-Antithrombotic removal (ATR) device is a polymer sorbent-filled hemoadsorption cartridge that can remove unbound (active) fractions of ticagrelor and ticagrelor active metabolite (TAM) from blood. STAR-T was a randomized double-blind sham-controlled clinical trial investigating whether the intraoperative use of the device could reduce perioperative bleeding complications in patients undergoing CT surgery within 2 days of ticagrelor discontinuation. Blood samples were collected during the study for total drug level measurements because the ability to measure unbound ticagrelor and TAM (0.2% of total levels) requires an ultra-high sensitivity assay, which is not commercially available. A published and validated pharmacokinetic (PK) model was used to explore the effect of the device on unbound ticagrelor/TAM using the total drug concentrations from the study. The model performed well for simulations of total ticagrelor and TAM, which indicated that the unbound concentrations were also appropriate. The model demonstrated that DrugSorb-ATR significantly reduced unbound ticagrelor and TAM concentrations. Linear and logistic regression analyses of summed ticagrelor and TAM concentrations showed that the DrugSorb-ATR device reduced the probability of clinically relevant bleeding in STAR-T because of the reduction in unbound ticagrelor and TAM.
Mould et al. (Sun,) reported a other. The DrugSorb-ATR device significantly reduced unbound ticagrelor and active metabolite levels, lowering the risk of clinically relevant bleeding in cardiac surgery patients.