CytoSorbents says STAR-T trial did not meet primary effectiveness endpoint

CytoSorbents announces an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board analysis for the pivotal U.S. and Canadian STAR-T randomized controlled trial. STAR-T is a double-blind, randomized, controlled, multi-center pivotal trial that investigated the ability of DrugSorb-ATR to reduce perioperative bleeding in 140 enrolled patients on ticagrelor undergoing cardiothoracic surgery before completing the recommended washout period. Patients were randomized in a 1:1 ratio to receive either DrugSorb-ATR or a sham device during cardiopulmonary bypass, with a primary composite effectiveness endpoint measuring perioperative bleeding. The independent DSMB met recently to perform the final review of the full unblinded data on all 140 patients in the STAR-T trial and concluded there were no issues with device safety, meeting the primary safety endpoint of the study. The Company has also performed the initial data analysis on the primary effectiveness endpoint of STAR-T. Based on this analysis, the study did not meet the primary effectiveness endpoint in the overall patient population that underwent different types of cardiac surgeries. However, the study did demonstrate evidence of reduced bleeding complications in patients in the pre-specified isolated coronary artery bypass graft surgery population, representing more than 90% of the overall study population. The Company expects to complete the analysis of the full trial results in the next several weeks. Pending this final analysis, the Company believes the safety and effectiveness data from STAR-T may support the regulatory submission of DrugSorb-ATR to the U.S. FDA and Health Canada. Meanwhile, the Company had previously submitted a promissory abstract to the American College of Cardiology 2024 conference, triggering a “silent” period for publicly discussing detailed study results. If accepted, the full results of the STAR-T trial are expected to be presented next April 2024 in Atlanta.