Key result
STAR-T evaluates if DrugSorb-ATR reduces postoperative bleeding in cardiac surgery patients with recent ticagrelor exposure.
Why the study?
Ticagrelor increases surgical bleeding risk in patients requiring urgent cardiothoracic surgery, and the effectiveness of intraoperative ticagrelor removal to reduce bleeding is unknown.
Does the DrugSorb-ATR hemoadsorption device reduce postoperative bleeding in patients undergoing cardiothoracic surgery within 48 hours of their last ticagrelor dose?
RCT (n=120)
Double-blind
1:1
Yes
Does the DrugSorb-ATR hemoadsorption device reduce postoperative bleeding in patients undergoing cardiothoracic surgery within 48 hours of their last ticagrelor dose?
The STAR-T trial is designed to evaluate whether intraoperative hemoadsorption can safely remove ticagrelor and reduce bleeding in patients requiring urgent cardiothoracic surgery.
Device use was associated with reduced bleeding in urgent CT surgery; leaves open benefit in routine practice pending randomized confirmation.
BACKGROUND: Ticagrelor is often administered to patients with acute coronary syndromes. However, when these patients require urgent or emergent cardiothoracic (CT) surgery the presence of ticagrelor significantly increases surgical bleeding. The goal of the current trial is to evaluate the effectiveness and safety of the DrugSorb-ATR hemoadsorption device for the intraoperative removal of ticagrelor to reduce postoperative bleeding in the above patient population. The Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) Trial is a multi-center, double-blind, randomized, controlled trial enrolling patients who require cardiothoracic surgery on cardiopulmonary bypass (CPB) within 48 hours of last ticagrelor dose. METHODS: Subjects will be randomized 1:1 to receive either the DrugSorb-ATR device or an identical sham device during CPB. The study will enroll up to 120 subjects at 20 U.S centers, and the primary outcome is the composite of fatal perioperative bleeding, moderate/severe/massive bleeding according to the Universal Definition of Perioperative Bleeding in Cardiac Surgery (UDPB), and 24 hours chest tube drainage. The components of the composite are hierarchically ranked according to clinical significance and the primary analysis will utilize the Win Ratio method. Percent change in ticagrelor levels before and after CPB (drug removal) will be the key secondary endpoint. An independent Clinical Events Committee will adjudicate all clinical endpoints including safety endpoints relating to postoperative thrombotic events. Subjects will be followed through 30 days after the index operation. CONCLUSIONS: The results from STAR-T, if positive, will potentially support FDA market approval for DrugSorb-ATR, and provide a solution to an important unmet clinical need.
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Gibson et al. (2021) conducted an RCT in Patients requiring cardiothoracic surgery within 48 hours of last ticagrelor dose (n=120). DrugSorb-ATR device vs. Sham device was evaluated on Composite of fatal perioperative bleeding, moderate/severe/massive bleeding according to the Universal Definition of Perioperative Bleeding in Cardiac Surgery (UDPB), and 24 hours chest tube drainage. The STAR-T trial is designed to evaluate whether the DrugSorb-ATR device reduces postoperative bleeding in patients undergoing cardiothoracic surgery within 48 hours of last ticagrelor dose.