CytoSorbents Therapy Reduces Severe Bleeding in Urgent CABG Patients on Ticagrelor

CytoSorbents Therapy has been shown to significantly reduce bleeding in urgent CABG patients on ticagrelor in a new data analysis presented at EuroPCR 2025. The real-world analysis found a statistically significant reduction in severe bleeding and transfusion needs in CABG patients on ticagrelor with CytoSorbents Therapy. The device group showed a reduction in severe bleeding complications, including a 10.7% rate of BARC-4 severe bleeding compared to 33% in the control group.

A new real-world data analysis presented at EuroPCR 2025 has demonstrated that CytoSorbents Therapy significantly reduces bleeding in urgent coronary artery bypass grafting (CABG) patients on ticagrelor. The study, titled "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data," was presented by Professor Robert F. Storey, co-Principal Investigator of the international STAR Registry.

The analysis compared two patient populations undergoing urgent CABG surgery on ticagrelor before completing the recommended three-day washout period. The device group, consisting of 150 patients from the STAR Registry who were operated on with CytoSorbents' device, showed statistically significant reductions in severe bleeding complications compared to the control group of 644 patients operated without the device.

Key findings include:
- A reduction in the rate of BARC-4 severe bleeding from 33% in the control group to 10.7% in the device group (p0.001).
- A reduction in large transfusion events (≥5 units of blood) from 27% in the control group to 6% in the device group (p0.001).
- A reduction in the need for re-operations to control bleeding from 9.6% in the control group to 4% in the device group (p=0.02).

No device-related adverse events or device deficiencies were reported, underscoring the safety and ease of use of the technology in clinical practice.

CytoSorbents Corporation, the developer of CytoSorbents Therapy, is a leader in the treatment of life-threatening conditions through blood purification. The company's proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids.

The company's lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than a quarter million devices used cumulatively to date. CytoSorbents is also developing the DrugSorb™-ATR antithrombotic removal system in the United States, which has received two FDA Breakthrough Device Designations.

The company's De Novo Request for the DrugSorb-ATR device to reduce the severity of perioperative bleeding in CABG patients on ticagrelor was denied by the FDA in April 2025, but the company believes these items can be effectively resolved through the formal appeal process.

The new data from EuroPCR 2025 supports the growing evidence base for the clinical value of CytoSorbents Therapy in reducing bleeding complications in ticagrelor-treated patients undergoing urgent CABG surgery.

References:
[1] https://www.prnewswire.com/news-releases/cytosorbents-therapy-significantly-reduces-bleeding-in-urgent-cabg-patients-on-ticagrelor-in-new-data-presented-at-europcr-2025-302463239.html