$CTSOSep 2, 2026, 11:29 AMAI processed
Real-world data: CytoSorb cuts severe bleeding in CABG patients on ticagrelor; FDA pre-sub meetings advance DrugSorb‑ATR plans
AI Summary
CytoSorbents (CTSO) reported a patient-level matched real-world analysis of 587 urgent CABG patients on ticagrelor showing intraoperative CytoSorb use was associated with a 37% relative reduction in severe perioperative bleeding (BARC‑4: 21.8% vs 34.5%) and an NNT of 8, plus reductions in 24‑hr chest tube drainage and RBC transfusions with no serious device‑related adverse events. The company said the data—presented at ESC 2026—will be a core component of an expanded De Novo submission for DrugSorb‑ATR under FDA Breakthrough designation and that recent FDA pre-submission meetings were constructive for parallel ticagrelor and DOAC applications, with a planned new De Novo submission in early 2027.
Positives
- 37% relative reduction in BARC‑4 severe bleeding (21.8% vs 34.5%) in a 587‑patient matched analysis
- Number needed to treat (NNT) = 8 to prevent one severe bleeding event after urgent CABG
- No serious device‑related adverse events reported
Negatives
- Data have not yet been submitted to or reviewed by the FDA
- DrugSorb‑ATR is investigational in the U.S. and not FDA approved; regulatory approval is still required
- Real‑world matched analysis is observational and potentially less definitive than randomized trial evidence