CytoSorbents to present second analysis from STAR Registry at EACTS meeting

CytoSorbents announced the upcoming original presentations at the 37th European Association of Cardio-Thoracic Surgery Annual Meeting in Vienna, Austria, from October 4-7, 2023, including the second analysis from the international Safe and Timely Antithrombotic Removal Registry. The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb for antithrombotic drug removal in the acute hospital setting. The registry collects cases using CytoSorb to purify the blood of the major modern antithrombotic agents such as Brilinta/Brilique, Plavix, Effient, Pradaxa, Savaysa/Lixiana, Xarelto, and Eliquis in a variety of clinical scenarios, but particularly in cardiothoracic surgery, where the blood thinners can potentially cause serious and even fatal bleeding. The STAR Registry, not to be confused with the completed U.S. and Canada STAR-T pivotal trial, is enrolling ahead of internal projections with plans for ongoing presentations at large, international conferences. The first registry analysis entitled, “Insights from the International Safe and Timely Antithrombotic Removal Registry” was presented at the EuroPCR conference in May 2023, the largest interventional cardiology conference in the E.U., attracting 11,500+ participants this year. This analysis included 67 patients from 7 centers in the U.K. and Germany who underwent coronary artery bypass graft surgery within 2 days of Brilinta administration with a high risk of perioperative bleeding. The analysis reported no device related adverse events and low rates of BARC-4 bleeding, reoperation for bleeding, and 24-hour chest tube drainage. BARC-4 bleeding is defined as CABG-related bleeding that includes at least one of the following: perioperative intracranial bleeding, reoperation after closure of the chest for the purpose of controlling bleeding, transfusion of 5 units or more of whole blood or packed red blood cells within a 48-hour period, or chest tube output of 2 liters or more within a 24-hour period. These results compared favorably to the results, referred to in the presentation, from an often cited analysis of the SWEDEHEART registry, the national Swedish registry of all patients hospitalized for acute coronary syndrome or undergoing percutaneous coronary intervention or heart surgery, published in the European Heart Journal. In this study, Hannson and colleagues reported an average 31.4% incidence of severe BARC-4 bleeding in a cohort of patients who similarly required CABG surgery within 48 hours of ticagrelor administration but did not get CytoSorb. In addition, patients in this cohort had 12-hour chest tube drainage of 813 +/- 478 mL and 641 +/- 337 mL following CABG surgery within 24 and 48 hours, respectively, from last ticagrelor administration, which was more CTD than seen in patients treated with CytoSorb in the first STAR Registry analysis, yet in only half the time. In the entire study, which included patients who had a chance to wash out the drug for more than 5 days prior to surgery which accounted for approximately 2/3rds of all patients, reoperations due to bleeding was 6.1%. The second analysis of the International STAR Registry being presented at the 2023 EACTS conference next week, entitled “Intraoperative hemoadsorption for antithrombotic drug removal during cardiac surgery: the International Safe and Timely Antithrombotic Removal Registry,” summarizes the use of CytoSorb in patients on blood thinners undergoing a much broader range of heart surgeries than reported previously, mixing isolated CABG patients with more complex and invasive procedures at higher risk of perioperative bleeding including valve replacement, CABG + valve replacement, aortic surgery, and heart transplant. It also includes, for the first time, data on patients being treated with CytoSorb to reduce seven different antithrombotic medications. The analysis is divided between two groups: 114 patients on antiplatelet drugs including Brilinta, Plavix, and Effient; and 51 patients on the direct oral anticoagulants including Eliquis, Xarelto, Savaysa/Lixiana, and Pradaxa. The overall study population was taken from 8 centers in Germany, the United Kingdom, Austria, and Sweden. The antiplatelet analysis focuses on the use of intraoperative CytoSorb on 114 patients on antiplatelet agents undergoing isolated CABG, or higher risk cardiothoracic surgeries including valve replacement, aortic surgery, and heart transplant. 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 and Effient, 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 analysis reports on the use of CytoSorb intraoperatively in patients on Eliquis, Xarelto, Savaysa/Lixiana, and Pradaxa undergoing a more evenly divided set of procedures including isolated CABG, CABG + valve replacement, isolated valve replacement, Aortic surgery, and other procedures. 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.