CytoSorbents Medical Inc. 305 College Road E, Princeton, NJ-08540, USA.
Department of Medicine at Beth Israel Deaconess Medical Center, The Baim Institute and Harvard Medical School, Boston, MA-02215, USA.
Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):847-856. doi: 10.1093/ehjcvp/pvac036.
To evaluate the ability of the DrugSorb™-AntiThrombotic Removal (ATR) haemoadsorption device utilizing porous polymer bead sorbent technology to remove three commonly used antithrombotic drugs from whole blood.
We evaluated the removal of apixaban, rivaroxaban, and ticagrelor by the DrugSorb-ATR haemoadsorption device in a benchtop clinical scale model using bovine whole blood. Blood spiked at clinically relevant concentrations of an antithrombotic agent was continuously circulated through a 300-mL DrugSorb-ATR haemoadsorption device at a flow rate of 300 mL/min. Drug concentration was monitored over 6 h to evaluate drug removal. Results were compared with a control circuit without the haemoadsorption device. Removal rates at 30, 60, 120, and 360 minutes were: apixaban: 81.5%, 96.3%, 99.3% >99.8%; rivaroxaban: 80.7%, 95.1%, 98.9%, >99.5%; ticagrelor: 62.5%; 75%, 86.6%, >95% (all P <0.0001 vs. control). Blood pH and haematological parameters were not significantly affected by the DrugSorb-ATR haemoadsorption device when compared with the control circuit.
DrugSorb-ATR efficiently removes apixaban, rivaroxaban, and ticagrelor in a clinical-scale benchtop recirculation circuit with the bulk of removal occurring in the first 60 minutes. The clinical implications of these findings are currently investigated in patients undergoing on-pump cardiothoracic surgery in two US pivotal trials (ClinicalTrials.gov Identifiers: NCT04976530 and NCT05093504).
评估利用多孔聚合物珠吸附剂技术的 DrugSorb™-抗血栓去除（ATR）血液吸附装置从全血中去除三种常用抗血栓药物的能力。
我们使用牛全血在台式临床规模模型中评估了 DrugSorb-ATR 血液吸附装置对阿哌沙班、利伐沙班和替格瑞洛的去除作用。以 300mL/min 的流速将含有临床相关浓度抗血栓药物的血液连续循环通过 300mL 的 DrugSorb-ATR 血液吸附装置。监测 6 小时内的药物浓度以评估药物去除率。结果与不含血液吸附装置的对照回路进行比较。在 30、60、120 和 360 分钟时的去除率分别为：阿哌沙班：81.5%、96.3%、99.3%>99.8%；利伐沙班：80.7%、95.1%、98.9%、>99.5%；替格瑞洛：62.5%、75%、86.6%、>95%（均 P<0.0001 与对照相比）。与对照回路相比，DrugSorb-ATR 血液吸附装置对血液 pH 和血液学参数没有显著影响。
在临床规模的台式再循环回路中，DrugSorb-ATR 可有效去除阿哌沙班、利伐沙班和替格瑞洛，大部分去除发生在最初 60 分钟内。这些发现的临床意义目前正在接受两项美国关键性试验（ClinicalTrials.gov 标识符：NCT04976530 和 NCT05093504）的患者评估。
