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Rationale and Design of the Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) Trial: A Prospective, Multi-center, Double-blind, Randomized Controlled Trial Evaluating Reductions in Postoperative Bleeding with Intraoperative Removal of Ticagrelor by the DrugSorb™-ATR Device in Patients Undergoing Cardiothoracic Surgery within 48hrs from Last Ticagrelor Dose
C Michael Gibson et al. Am Heart J. 2021.
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Am Heart J
. 2021 Nov 1;S0002-8703(21)00442-7.
doi: 10.1016/j.ahj.2021.10.188. Online ahead of print.
Authors

C Michael Gibson 1 , Michael J Mack 2 , Victoria T Lee 3 , David J Schneider 4 , Frank W Sellke 5 , E Magnus Ohman 6 , Vinod H Thourani 7 , Gheorghe Doros 8 , Hans Kroger 3 , Donald E Cutlip 9 , Efthymios N Deliargyris 3
Affiliations

1 The Baim Institute and Harvard Medical School, Boston MA. Electronic address: [e-mail].
2 Baylor Scott & White Health, Baylor Scott & White Research Institute, Dallas, TX.
3 CytoSorbents Inc. Princeton, NJ.
4 Department of Medicine and Cardiovascular Research Institute, University of Vermont, Burlington VT.
5 Division of Cardiothoracic Surgery, Alpert Medical School of Brown University, Providence RI.
6 Duke Clinical Research Institute, Duke Program for Advanced Coronary Disease, Duke University Medical Center, Durham NC.
7 Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta GA.
8 The Baim Institute and Harvard Medical School, Boston MA; Boston University School of Public Health, Boston MA.
9 The Baim Institute and Harvard Medical School, Boston MA.
PMID: 34736855
DOI: 10.1016/j.ahj.2021.10.188
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Abstract

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. 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 24hr 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. The results from STAR-T, if positive, will potentially support FDA clearance of the device.