Mitigating Bleeding Risks in Patients on Antithrombotic Drugs Undergoing Cardiac Surgery

STAR Registry Unveils Promising Insights

Prof Dr Daniel Wendt on: Intraoperative hemoadsorption for antithrombotic drug removal during cardiac surgery: Initial report of the International Safe and Timely Antithrombotic Removal (STAR) Registry

Schmoeckel M, Thielmann M, Hassan K, Geidel S, Schmitto J, Meyer AL, Vitanova K, Liebold A, Marczin N, Bernardi MH, Tandler R, Lindstedt S, Matejic-Spasic M, Wendt D, Deliargyris EN, Storey RF. J Thrombosis & Thrombolysis 2024: epub

Antithrombotic (AT) drugs are cornerstone therapies for patients with cardiovascular disease. These drugs have been shown to reduce recurrent ischemic events and to provide consistent survival benefits. There are two classes of antithrombotic drugs:
1. So-called blood thinners, including the novel direct-acting oral anticoagulants (DOACs) which have gradually replaced warfarin over the last decade and which are continuing to grow at a rapid rate (forecasted to reach a market volume of more than 70$ billion in 2032).
2. Anti-platelet drugs including novel P2Y12 receptor antagonists such as ticagrelor, routinely prescribed in patients with acute coronary syndromes or after percutaneous coronary interventions.

The major safety risk associated with all these AT drugs is bleeding which can be either spontaneous or iatrogenic when patients require urgent or emergent interventions including major surgery, such as cardiac. Many of these AT drugs can be quickly and effectively removed from blood by hemoadsorption therapy. This novel approach is increasingly used to reduce perioperative bleeding in patients on a broad range of AT drugs undergoing urgent or emergency cardiac surgery.

The STAR registry, a collaborative effort across multiple international centers in Europe, analyzed bleeding outcomes in patients on AT drugs undergoing cardiac surgery with CytoSorb hemoadsorption installed
 into the cardiopulmonary bypass circuit.

A recent publication by  Schmoeckel et al. has explored the outcomes in two distinct patient groups: those on P2Y12 inhibitors and those on DOACs. Of note, the time from the last dose (mean washout period) in both groups was less than 48 hours, so far below the guideline recommended washout-period of 72 hours.

The registry’s initial findings offer valuable insights into the efficacy and safety of intraoperative hemoadsorption with CytoSorb. The paper summarizes for the first time the interim results, outcomes and bleeding complications in patients treated with oral AT drugs. Not surprisingly, most of the patients in the P2Y12 inhibitor group were coronary artery bypass graft (CABG) patients with ticagrelor being the most frequently used AT drug. In the DOAC group, apixaban was the most frequently prescribed drug. Across both groups the study reports acceptable rates of serious bleeding events and low surgical re-explorations (overall 7 re-operations in 165 patients: 4.2%). As such, the data suggests that intraoperative use of CytoSorb can reduce the high rates of severe bleeding reported in patients operated on before completing the full washout period. Importantly, no serious adverse device-related events were observed, as classified by all the investigators. Looking ahead, the STAR registry will continue to generate data in up to 1,000 patients. All these endeavors hold promise for refining perioperative management strategies and enhancing patient outcomes in cardiac surgery where the patient has only recently stopped their AT.

In summary, despite the inherent challenges posed by urgent or emergent surgeries, the STAR registry underscores the potential of CytoSorb hemoadsorption therapy to modulate bleeding risks effectively. Therefore, it should provide high fidelity evidence to start a discussion and maybe paradigm shift in bleeding management strategies for patients on AT therapy undergoing cardiac surgery. Stay tuned as we continue to unravel the evolving landscape of cardiac surgery and explore innovative avenues aimed at optimizing patient outcomes and advancing surgical excellence. There is more to come with the latest results of the STAR registry in patients undergoing early CABG with intraoperative hemoadsorption in patients on ticagrelor being presented at the latest EuroPCR meeting in Paris, 2024. We are happy to share that the abstract was voted the 2nd best scientific abstract at this congress.

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About the Author

Prof Dr. Wendt, a cardiac surgeon based in Essen, formerly served as the co-director of the Westgerman Heart and Vascular Center in Essen until 2021. From January 1st 2022, he was appointed as Vice President (cardiovascular) of the company CytoSorbents. His medical expertise covers the whole field of adult cardiac surgery, and he is also specialized in intensive care medicine. Moreover, he is member of numerous medical societies, and he serves as Editorial Board member for many scientific journals. So far, he published more than 150 peer-reviewed articles.