CytoSorbents Highlights Upcoming Presentations at EACTS 2023

Focus on Antithrombotic Removal including the 2nd Analysis of the International STAR Registry - Seite 3

The antiplatelet analysis focuses on the use of intraoperative CytoSorb on 114 patients on antiplatelet agents undergoing isolated CABG (78%), or higher risk cardiothoracic surgeries including valve replacement, aortic surgery, and heart transplant (22%). The rate of BARC-4 bleeding for isolated CABG surgery alone was 4.5%, while overall BARC-4 bleeding was 13.2%, reflecting the higher bleeding risk of the more complex surgeries and the use of Plavix (17%) and Effient (3%), historically thought to be irreversible platelet inhibitors, in 20% of the patients. In the future, in addition to generating more data on the clinical impact of removing Brilinta/Brilique, the STAR Registry is also expected to help answer the question of whether CytoSorb can mitigate the bleeding risk in patients on Plavix and Effient in ways not related to drug binding to the platelet.

The Direct Oral Anticoagulant (DOAC) analysis reports on the use of CytoSorb intraoperatively in patients on Eliquis (47%), Xarelto (27%), Savaysa/Lixiana (24%), and Pradaxa (2%) undergoing a more evenly divided set of procedures including isolated CABG (23.5%), CABG + valve replacement (15.7%), isolated valve replacement (17.6%), Aortic surgery (15.7%), and other procedures (27.5%). There was no BARC-4 bleeding in the 12 patients undergoing isolated CABG surgery, with 15.7% BARC-4 bleeding overall, reflecting the higher proportion of higher risk and more invasive surgeries.

The international STAR Registry authors concluded that for this analysis, for “patients undergoing cardiac surgery before the recommended washout period, the use of intraoperative antithrombotic drug removal is associated with lower incidence of serious bleeding compared with historical rates,” and “importantly, no serious device-related adverse events were observed.”

Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents, stated, “We believe the STAR Registry provides a powerful platform to systematically collect high quality, real-world outcomes data on the ability of CytoSorb to reduce perioperative bleeding risk in patients on a variety of antithrombotic drugs undergoing cardiothoracic surgery on an international scale. Given that DrugSorb-ATR uses an equivalent polymer technology as CytoSorb, we believe the outcomes seen in the STAR registry analysis are encouraging and provide greater insights into the clinical benefits of antithrombotic removal that are also investigated in our U.S. and Canada STAR-T and STAR-D programs.”