Risk Reduction by Direct Thrombin Antagonism During ECMO Therapy

ECMO patients can develop heparin (Hep)-induced thrombocytopenia type II (HIT II). Approval for direct thrombin antagonism is lacking. We analyze if direct thrombin antagonism (DTA) is feasible, safe, and not inferior to heparin.A total of 254 multicenter prospective patients (vv- or va-ECMO) were analyzed in four different cardiothoracic, pulmonary, or anesthesiological intensive care units at university hospitals in Giessen and Frankfurt from 2020 to 2022.Heparin was always received by 153 va-ECMO/101 vv-ECMO patients (95/43), only DTA (8/6) or a switch (50/52) from heparin to DTA in cases of suspected HITII and reduced platelet count (reduction: p = 0.017). ICU morbidity, survival, therapeutic stability of anticoagulation, bleeding, thrombosis, and technical integrity were analyzed regarding noninferiority and superiority of DTA versus heparin. Patients who changed anticoagulation showed increased infection levels before the change. Before switching from heparin to DTA, there was only a moderate increase in the INR, a decrease in the Quick, and no therapeutic increase in the PTT with heparin. With regard to thrombosis and system occlusions, there is no difference between heparin and DTA. Weaning rates from extracorporeal support and survival analysis did show noninferiority of DTA. After switching, a clear superiority of DTA in terms of (A) overall complication rate CI((0.6479/0.7871/0.9546)) (defined as bleeding from any cause, stroke, amputation, thrombosis and device-occlusion) and (B) bleeding from any cause alone CI((0.6432/0.7829/0.9513)) and a noninferiority in terms of preventing strokes exists.DTA is not inferior to heparin in ECLS/ECMO therapy. Regarding all complications, stroke, thromboembolism, and amputation DTA is superior.