CytoSorb Cuts Severe Bleeding by 37% in Urgent CABG Patients on Ticagrelor, Real-World Data Show
核心洞察
A patient-level matched analysis of 587 urgent CABG patients found intraoperative CytoSorb (搜索) use reduced BARC-4 severe bleeding by 37% (21.8% vs 34.5%; p=0.002).
The number needed to treat (NNT) to prevent one severe bleeding event was eight, consistent with the NNT of six seen in the randomized STAR-T trial.
Significant reductions in 24-hour chest tube drainage (p=0.039) and red blood cell transfusions (p=0.003) were observed, with no serious device-related adverse events.
CytoSorbents Corporation (搜索) (NASDAQ: CTSO) announced on September 2, 2026 that an independent patient-level matched analysis of real-world data demonstrated a significant reduction in severe perioperative bleeding among patients undergoing urgent coronary artery bypass grafting (搜索) (CABG) surgery while on the blood thinner ticagrelor (Brilinta®/Brilique®, AstraZeneca). The findings, presented at the European Society of Cardiology (ESC) Congress 2026 on August 29, 2026, showed that intraoperative use of CytoSorb (搜索) was associated with a 37% relative reduction in BARC-4 severe bleeding.
Patients requiring urgent cardiac surgery after recent exposure to potent blood thinners face substantially higher risks of severe bleeding, transfusions, complications, longer hospital stays, and increased costs. Historically, surgeries were delayed by three to seven days to allow the drugs to clear. CytoSorb (搜索) offers a potentially significant alternative as the only specifically approved therapy in the E.U. for removing ticagrelor and rivaroxaban during cardiopulmonary bypass.
Real-World Evidence Findings
The patient-level matched analysis included a total of 587 patients undergoing urgent CABG surgery after recent ticagrelor exposure. Patients treated with intraoperative CytoSorb (搜索) (n=198) from the STAR-T Registry were compared with matched patients from a previously published individual patient data meta-analysis (n=389) who underwent surgery without the device.
The independent analysis demonstrated a significant 37% relative reduction in BARC-4 severe bleeding with CytoSorb (搜索) use (21.8% vs 34.5% in controls; p=0.002). The number of patients needed to be treated (NNT) with CytoSorb to prevent one severe bleeding event after urgent CABG was eight. Significant reductions in 24-hour chest tube drainage (p=0.039) and red blood cell transfusions (p=0.003) with CytoSorb use were also observed. No serious device-related adverse events were reported.
Expert Commentary
Prof. Dr. Uwe Zeymer, Vice Director of the Institute for Heart Attack Research in Ludwigshafen, Germany and Co-Principal Investigator of the STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) Registry, stated, "Today's presentation at the ESC meeting using robust statistical adjustments, demonstrates that in real world patients on ticagrelor undergoing urgent CABG, the use of CytoSorb (搜索) is associated with significant reductions in severe bleeding rates compared with rates observed when patients on ticagrelor are operated without the device."
Dr. Zeymer added that the NNT of eight "is a clinically important result and is highly consistent with the NNT of 6 to prevent a major bleeding event demonstrated in the double-blind randomized STAR-T trial published earlier this year." He noted the results "validate the testimonials from cardiac surgeons throughout Europe who have made CytoSorb (搜索) their standard of care when operating urgently on patients on blood thinners," and indicated plans to extend the evidence base to direct oral anticoagulants such as apixaban and rivaroxaban.
Regulatory Pathway for DrugSorb-ATR
Phillip Chan, CEO of CytoSorbents, said the real-world findings "provide important new evidence of CytoSorb (搜索)'s performance in routine clinical practice in CABG patients facing this critical clinical dilemma." He indicated the analysis is expected to serve as a core component of additional clinical evidence in a new De Novo submission for DrugSorb-ATR (搜索), initially proposed by the FDA as part of last year's appeal, to support its probable benefit in reducing the severity of perioperative bleeding in patients on Brilinta® undergoing urgent cardiac surgery.
These data have not yet been submitted or reviewed by the Agency but are expected to increase approximately five-fold the number of patients treated with the technology in a new De Novo submission, to roughly 250 patients. CytoSorbents reported continued constructive engagement with the FDA, with recent Pre-Submission discussions helping align the Company and FDA on the mechanistic data and evaluation model needed to support the application. A new De Novo submission is targeted for early 2027 under the Breakthrough Device designation.
In parallel, the Company is pursuing a second regulatory pathway for DrugSorb-ATR (搜索) in cardiac surgery patients taking direct oral anticoagulants (DOACs), including Eliquis® (apixaban, Bristol Myers Squibb (搜索)/Pfizer) and Xarelto® (rivaroxaban, Bayer (搜索)/Janssen). A recent FDA meeting addressed a number of questions and provided further clarity on the potential regulatory path, with a follow-up meeting expected in the near term.
CytoSorb (搜索)® is approved in the European Union and distributed in over 70 countries worldwide, with more than 300,000 devices used cumulatively to date. CytoSorb® and DrugSorb-ATR (搜索)® are investigational devices in the United States and not yet approved or cleared by the FDA.