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Reduce peri-operative bleeding risk in patients on ticagrelor / rivaroxaban (1)

CytoSorb Therapy in urgent and emergent cardiac surgery

Indicated for intraoperative
ticagrelor / rivaroxaban removal
during cardiopulmonary bypass (CPB)

Background

Ticagrelor

Ticagrelor is a reversible inhibitor of the P2Y12 platelet receptor and is indicated for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.

Rivaroxaban

Rivaroxaban, a factor Xa inhibitor, is a novel oral anticoagulant (NOAC) indicated for the prevention of stroke in patients with atrial fibrillation and for prevention or treatment of deep vein thrombosis and pulmonary embolism.

In order to prevent bleeding complications, EACTS/EACTA Guidelines
recommend discontinuation of both drugs prior to cardiac surgery (2):

≥ 3 days for ticagrelor

≥ 2 days for rivaroxaban

In case of urgent or emergent surgery with no time to wait, ticagrelor or rivaroxaban can lead to an increase in peri-operative bleeding.

CytoSorb is intended to remove ticagrelor or rivaroxaban during cardiopulmonary
bypass surgery to help reduce bleeding complications. (*)

Clinical outcome data (1)

* The indications of CytoSorb within the CE mark do not cover removal of any other anti-thrombotic medications.
** Similar CPB/cross clamp time in both groups.
*** P-values reflect significant differences in the means between patients treated with CytoSorb and the control group, irrespective of the drug.

Health economic impact

CytoSorb has a high probability of saving costs. (3)

NICE Medtech innovation briefing (MIB) showed that over a 30-day time period, removal of ticagrelor using CytoSorb during surgery was less costly than delaying surgery for natural ticagrelor washout without adjunctive therapy. (4)

It was calculated from 2019 Hassan et al. study data that CytoSorb group cost savings derived from fewer blood product transfusions and re-thoracotomies, and shorter intensive care unit / hospital stay:

 
 
 
 
 
 
0 % (1, ‡)
Operation time reduction
0 % (1, ‡)
RBC transfusions reduction
0 % (1, ‡)
PLT transfusions reduction
0 % (1, ‡)
ICU days reduction

No re-thoracotomies were observed

Principal investigator’s conclusion

“The intraoperative use of the CytoSorb hemoadsorption in patients with ticagrelor or rivaroxaban treatment undergoing emergency open-heart operations is a safe and effective method to reduce bleeding complications and to improve the postoperative outcome.” (1)

“We recommend the use of CytoSorb adsorption for safety in patients undergoing emergency cardiac surgery and medication with ticagrelor or rivaroxaban.“ (1)

Study description(1)

CytoSorb adsorption during emergency cardiac operations in patients at high risk of bleeding
Hassan K, Kannmacher J, Wohlmuth P, Budde U, Schmoeckel M, Geidel S
Annals of Thoracic Surgery 2019;108:45–51

This study included 55 consecutive patients undergoing emergency open-heart operations who were at high risk of bleeding due to prior treatment with anti-thrombotic medications (43 patients on ticagrelor, 12 on rivaroxaban). In 39 of 55 cases, CytoSorb adsorption was installed into the cardiopulmonary bypass. Bleeding complications during and after surgery were analyzed in detail and compared to the 16 patients without CytoSorb (11 patients on ticagrelor, 5 on rivaroxaban).

‡ Weighted average calculated based on data provided by Hassan et al.(1)

CytoSorb integration into CPB

Watch Prof. Pascal Leprince and PD Dr. Stephan Geidel present their clinical outcome data

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References:
(1) Hassan K et al., Annals of Thoracic Surgery 2019;108(1):45-51 (2) Boer C et al., Journal of Cardiothoracic and Vascular Anesthesia 2018; 32: 88–120
(3) Javanbakht M et al., PharmacoEconomics Open 2020;4:307-319 (4) NICE Medtech innovation briefing, February 2021; www.nice.org.uk/guidance/mib249

Visit our Literature Database for an overview of all references.

CytoSorb Therapy is an extracorporeal blood purification in conditions where elevated levels of cytokines and/or bilirubin and/or myoglobin exist. CytoSorb can also be used intraoperatively for the removal of ticagrelor and/or rivaroxaban during Cardiopulmonary-Bypass.

The clinical and preclinical data and results obtained with the CytoSorb adsorber are not transferable to other products. CytoSorb should only be administered by personnel who have been properly trained in administration of extracorporeal therapies. CytoSorb is not available for commercial sale in USA.