by Christoph Fisser, Maren Winkler, Maximilian V.
Malfertheiner, Alois Philipp, Maik Foltan, Dirk Lunz, Florian Zeman, Lars S.
Maier, Matthias Lubnow and Thomas Müller
Critical Care volume 25,
Article number: 160 (2021)
Background
During venovenous extracorporeal membrane oxygenation
(vvECMO), direct thrombin inhibitors are considered by some potentially
advantageous over unfractionated heparin (UFH). We tested the hypothesis that
Argatroban is non-inferior to UFH regarding thrombosis and bleeding during
vvECMO.
Methods
We conducted a propensity-score matched observational
non-inferiority study of consecutive patients without
heparin-induced-thrombocytopenia (HIT) on vvECMO, treated between January 2006
and March 2019 in the medical intensive care unit at the University Hospital
Regensburg. Anticoagulation was realized with UFH until August 2017 and with
Argatroban from September 2017 onwards. Target activated partial thromboplastin
time was 50 ± 5seconds in both groups. Primary composite endpoint was major
thrombosis and/or major bleeding. Major bleeding was defined as a drop in
hemoglobin of ≥ 2 g/dl/day or in transfusion of ≥ 2 packed red cells/24 h,
or retroperitoneal, cerebral, or pulmonary bleeding. Major thrombosis was
defined as obstruction of > 50% of the vessel lumen diameter by means of
duplex sonography. We also assessed technical complications such as oxygenator
defects or pump head thrombosis, the time-course of platelets, and the cost of
anticoagulation (including HIT-testing).
Results
Out of 465 patients receiving UFH, 78 were matched to 39
patients receiving Argatroban. The primary endpoint occurred in 79% of patients
in the Argatroban group and in 83% in the UFH group (non-inferiority for
Argatroban, p = 0.026). The occurrence of technical complications was
equally distributed (Argatroban 49% vs. UFH 42%, p = 0.511). The number of
platelets was similar in both groups before ECMO therapy but lower in the UFH
group after end of ECMO support (median [IQR]: 141 [104;198]/nl vs. 107
[54;171]/nl, p = 0.010). Anticoagulation costs per day of ECMO were higher
in the Argatroban group (€26 [13.8;53.0] vs. €0.9 [0.5;1.5], p < 0.001)
but not after accounting for blood products and HIT-testing (€63 [42;171) vs. €40
[17;158], p = 0.074).
Conclusion
In patients without HIT on vvECMO, Argatroban was
non-inferior to UFH regarding bleeding and thrombosis. The occurrence of
technical complications was similarly distributed. Argatroban may have less
impact on platelet decrease during ECMO, but this finding needs further
evaluation. Direct drug costs were higher for Argatroban but comparable to UFH
after accounting for HIT-testing and transfusions.
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