CytoSorbents Initiates ‘STAR-T’ DrugSorb-ATR Antithrombotic Removal Trial

CytoSorbents, a company specializing in treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR–T) double-blind, randomized, controlled clinical trial designed to support FDA marketing approval of the DrugSorb-ATR Antithrombotic Removal System for intraoperative removal of ticagrelor during cardiothoracic surgery.  The STAR-T trial received full FDA IDE Approval in July 2021, and is being performed under the auspices of FDA Breakthrough Designation granted in April 2020.  The STAR-T trial is expected to enroll up to 120 patients across 20 sites and be completed by 2022.  The first patient was enrolled by Dr. Bradley S. Taylor, Chief of the Division of Cardiac Surgery and Director of Coronary Revascularization and site Principal Investigator at the University of Maryland Medical Center.
 
Dr. Bradley S. Taylor stated, “Ticagrelor is an antiplatelet agent routinely used in the management of patients with acute coronary syndrome to reduce the risk of death, myocardial infarction, and stroke.  However, when urgent surgery is required, patients on ticagrelor are at very high risk of serious and potentially fatal bleeding.  We are very pleased to enroll the first patient in the landmark STAR-T study that is investigating the ability of DrugSorb-ATR to remove ticagrelor during surgery and reduce the risk of bleeding in these patients. If positive, STAR-T could establish DrugSorb-ATR as an easily implemented solution that addresses a long-standing, frequent, and critical unmet medical need faced by cardiac surgery centers around the world.”
 
Dr. Efthymios N. Deliargyris, chief medical officer of CytoSorbents stated, “Removing antithrombotic agents intraoperatively with the DrugSorb-ATR system in patients requiring urgent cardiac surgery has the potential to save lives, reduce morbidity and provide substantial cost savings to heart centers around the world.  The FDA approved STAR-T trial has now left the station and we will work diligently to deliver on our stated goal to finish the trial in 2022.  Following the granting of a second Breakthrough Designation for the removal of apixaban and rivaroxaban, we recently received full FDA approval of our IDE application to conduct the Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) trial, a second, very similar study that will leverage the existing infrastructure of STAR-T.  We anticipate fast study start-up and estimate that the first patient will be enrolled early in 2022.  The goal of both studies is to gain FDA marketing approval for the most widely prescribed next generation antiplatelet and anticoagulant agents and unlock an estimated $1 billion U.S. market opportunity.”
 
In April 2020, the FDA granted CytoSorbents Breakthrough Device Designation to remove ticagrelor during cardiothoracic surgery, recognizing this major unmet medical need.  Each year, ticagrelor is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent heart attack, stroke, or cardiovascular death.  Ticagrelor is frequently preferred as first-line therapy in patients presenting to hospitals with an acute coronary syndrome in preparation of percutaneous coronary intervention (PCI) and stent placement.  However, up to 10% of these patients will require coronary artery bypass graft (CABG) open heart surgery. As several clinical studies, such as the PLATO trial, have shown, these patients face a very high risk of severe or life-threatening perioperative bleeding.  CytoSorbents’ CytoSorb therapy is the only treatment approved to remove ticagrelor during cardiopulmonary bypass in the E.U.  The DrugSorb-ATR Antithrombotic Removal system is based on the same polymer technology as CytoSorb.  If FDA marketing approval is obtained by the FDA, DrugSorb-ATR would be marketed in the United States for ticagrelor removal during urgent cardiothoracic surgery, with the intention of reducing the risk of bleeding.