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

CytoSorb Therapy in urgent and emergent cardiac surgery

Approved for intraoperative ticagrelor / rivaroxaban removal
during cardiopulmonary bypass (CPB) (2)

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. (3)

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. (4)

In order to prevent bleeding complications both drugs should be
discontinued prior to surgery:

≥ 3 days for ticagrelor (5,6)

≥ 2 days for rivaroxaban (5)

However, in case of urgent or emergent surgery with no time to wait,
ticagrelor or rivaroxaban can lead to increase in peri-operative bleeding. (1,6,7)

 
 
 
 
 
 
 

CytoSorb reduces bleeding complications in urgent or emergent surgery patients by effectively removing ticagrelor and rivaroxaban from the whole blood. (1,8)

The CytoSorb CE label now also includes intraoperative ticagrelor and rivaroxaban removal during cardiopulmonary bypass.(2,*)

Clinical outcome data (1)

* The CE label of CytoSorb does not cover removal of any other anti-thrombotic medications.
** Similar CPB/cross clamp time in both groups.

Health economic impact

CytoSorb has a high probability of saving costs. (9,10)

Cost savings derive from fewer blood product transfusions and re-thoracotomies, and shorter stay in the intensive care unit / hospital. (9)
 
 
 
 
 
 
- 0 % (1)
Operation time
- 0 % (1)
RBC transfusions
- 0 % (1)
Re-thoracotomies
- 0 % (1)
ICU days
- 0 % (1)
PLT transfusions

Conclusions according to the authors

“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).

CytoSorb integration into CPB

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

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References (Clinical and *preclinical data):
(1) Hassan K et al., Annals of Thoracic Surgery 2019;108(1):45-51(2) IFU CytoSorb 300, CytoSorbents Inc., USA, issue date 30-Jan-2020(3) ESC Clinical Practice Guidelines on DAPT, European Heart Journal 2018;39:213–260(4) Steffel J et al., European Heart Journal 2018; 39 (16): 1330–1393(5) Boer C et al., Journal of Cardiothoracic and Vascular Anesthesia 2018; 32: 88–120
(6) Hansson EC et al., European Heart Journal 2016;37:180-197(7) Kremke M et al., Eur J Cardiothorac Surg 2019;55(4):714-720(8) Angheloiu GO et al., J Am Coll Cardiol Basic Trans Science 2017;2:135–45(9) Javanbakht M et al., PharmacoEconomics Open 2019;epub(10) Data on file(11) Koertge et al., Blood Purification 2017;45(1-3):126-8

Visit our Literature Database for an overview of all references

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