Full Press Release Details
PRINCETON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the recent data presentation entitled “Early CABG with Intraoperative Haemoadsorption in Patients on Ticagrelor: The Safe and Timely Antithrombotic Removal (STAR) Registry,” at the international EuroPCR 2024 conference in Paris, France - the world-leading course in interventional cardiovascular medicine with over 12,000 attendees - where it was also selected as a top 5 finalist in the best scientific abstract competition.
Professor Robert F. Storey, Academic Director and Honorary Consultant Interventional Cardiologist, Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK and Co-Principal Investigator of the international STAR Registry, presented real-world outcomes on 102 patients on ticagrelor (Brilinta®/Brilique®, AstraZeneca) who underwent non-deferrable coronary artery bypass graft (CABG) surgery with intraoperative CytoSorb® blood purification before completing the recommended 3-day drug washout period, across 23 European heart centers in Germany, U.K., Austria, Sweden, and Belgium.
In these 102 patients, the mean time from the last dose of ticagrelor was 22.8 hours. The mean age was 63.8 years, approximately 80% were male, and 43% had diabetes
There were no device-related adverse events reported by investigators using intraoperative CytoSorb during CABG surgery
Overall, severe bleeding according to the Universal Definition of Perioperative Bleeding criteria (UDPB ≥ 3) occurred in 9.8% of patients
In a subgroup analysis, the study population was divided into 2 groups. Group 1 comprised patients operated <24 hours from last ticagrelor dose (n=61, mean time 12.6 ± 6.5 hours) and Group 2 comprised patients operated more than 24 but less than 72 hours from last dose (n=41, mean time 37.2 ± 10.1 hours). Demographics were similar between the two groups, however, Group 1 patients had significantly higher perioperative risk compared with Group 2 patients based upon the more frequent need for more hazardous emergency surgery (66.1% vs. 12.2%, p<0.001) and the higher baseline predicted surgical risk according to the standardized EuroScore II score (4.2 vs. 1.7, p=0.006). Expectedly, higher risk patients in Group 1 had a higher rate of severe bleeding compared with Group 2 patients (14.8% vs. 2.4%)
To provide historical context to these results, Professor Storey presented published results from the European Multicenter Registry on Coronary Artery Bypass Grafting (E-CABG) reporting postoperative UDPB ≥ 3 bleeding rates in patients on ticagrelor undergoing CABG surgery (without CytoSorb) within 24 hours from the last dose of 26.6% and in patients operated between 24 and 72 hours from last dose of 14.8%, both higher than what was observed in the STAR Registry when intraoperative CytoSorb was used in similar patients
“Waiting to undergo CABG surgery for 72 hours after ticagrelor dosing can expose patients to the risk of high platelet reactivity and recurrent ischemic events as the effects of ticagrelor wear off, in addition to causing logistic challenges for hospitals,” stated Professor Storey. "The STAR registry data show promising potential of intraoperative haemoadsorption in reducing the length of time that ticagrelor needs to be stopped before CABG surgery to prevent troublesome bleeding after surgery. Overall, this collective experience of hospitals using intraoperative haemoadsorption routinely for ticagrelor removal is very encouraging and supports further study of this approach. Finally, we are very grateful that the importance of the potentially practice-changing data we presented was recognized by the scientific program committee with the selection as a top 5 finalist for the best scientific abstract award among the hundreds of original presentations at this year’s EuroPCR conference.”
Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, “The STAR Registry data continue to provide real-world evidence that intraoperative use of CytoSorb in patients undergoing CABG surgery on ticagrelor is associated with lower rates of serious perioperative bleeding than observed historically when CytoSorb was not used. The goal of presenting these data at EuroPCR 2024, which was extremely well-attended by the full ecosystem of clinicians involved in the care of acute coronary syndrome patients including cardiologists, interventional cardiologists, and cardiothoracic surgeons, was to increase awareness through the entire chain of clinical care that CytoSorb is the only approved intervention that can expedite care for patients on ticagrelor needing surgical revascularization in the European Union. Since the other two mainstream anti-platelet agents, clopidogrel (Plavix®, BMS, Sanofi-Aventis) and prasugrel (Effient®, Eli Lilly, Daiichi Sankyo), have irreversible effects on platelets, we believe CytoSorb makes ticagrelor a better antiplatelet option for acute coronary syndrome patients since about 5-10% of them will eventually require definitive CABG surgery. This differentiating feature of ticagrelor, together with its upcoming loss of patent exclusivity and the availability of generic formulations, will likely further expand the market opportunity for CytoSorb.”
CytoSorb® is approved in the European Union for the removal of cytokines, bilirubin, and myoglobin. CytoSorb is also E.U. approved for the removal of the antithrombotic drugs, ticagrelor and rivaroxaban, during cardiothoracic surgery. CytoSorb® is not yet approved or cleared in the United States or Canada for any indication.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. It has neither been cleared nor approved in the U.S. for the indication to treat patients with COVID-19 Infection. The FDA EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act.
The DrugSorb™-ATR antithrombotic removal system, an Investigational Device based on the same polymer technology as CytoSorb, has received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company has completed the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
Forward-Looking Statements
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