CTSO - CytoSorbents Highlights Upcoming Presentations at EACTS 2023: Focus on Antithrombotic Removal including the 2nd Analysis of the International STAR Registry | Benzinga
PRINCETON, N.J., Sept. 27, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced the upcoming original presentations at the 37th European Association of Cardio-Thoracic Surgery (EACTS) Annual Meeting in Vienna, Austria, from October 4-7, 2023, including the second analysis from the international Safe and Timely Antithrombotic Removal (STAR) Registry.
Second Analysis of the International STAR Registry
The International STAR Registry captures high fidelity data on real-world clinical use and associated clinical outcomes using CytoSorb® for antithrombotic drug removal (ATR) 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 (STAR) 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 (CABG) surgery within 2 days of Brilinta® (ticagrelor) administration with a high risk of perioperative bleeding. The analysis reported no device related adverse events and low rates of BARC-4 bleeding (6%), reoperation for bleeding (4%), and 24-hour chest tube drainage (537 ± 231 mL). 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 (Brilinta®) administration but did not get CytoSorb. In addition, patients in this cohort had 12-hour chest tube drainage (CTD) 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 (STAR) Registry," summarizes the use of CytoSorb in patients on ...