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CC BY 4.0 · TH Open 2023; 07(03): e251-e261
DOI: 10.1055/s-0043-1774304
Original Article

Periinterventional Management of Edoxaban in Major Procedures: Results from the DRESDEN NOAC REGISTRY

Christina Köhler
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Luise Tittl
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Ulrike Hänsel
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Evelyn Hammermüller
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Sandra Marten
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Christiane Naue
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Marianne Spindler
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Laura Stannek
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Kristina Fache
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
,
Jan Beyer-Westendorf
1   Division of “Thrombosis and Hemostasis,” Department of Medicine I, University Hospital “Carl Gustav Carus,” Technical University Dresden, Dresden, Germany
› Author Affiliations Funding The DRESDEN NOAC REGISTRY is supported by the Gesellschaft für Technologie- und Wissenstransfer der Technischen Universität Dresden (GWT-TUD GmbH), Germany (sponsor) and by grants from Bayer AG, Boehringer Ingelheim, Daiichi Sankyo and Pfizer. All authors declare that these companies and institutions had no influence on the study design, conduct of the study, data collection, statistical analysis, or preparation of the manuscript.
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Abstract

Background Edoxaban is a non-vitamin K dependent oral anticoagulant (NOAC) licensed for venous thromboembolism (VTE) treatment or stroke prevention in atrial fibrillation. Major surgical procedures are not uncommon in anticoagulated patients but data on perioperative edoxaban management are scarce.

Patients and Methods Using data from the prospective DRESDEN NOAC REGISTRY, we extracted data on major surgical procedures in edoxaban patients. Periinterventional edoxaban management patterns and rates of outcome events were evaluated until day 30 after procedure.

Results Between 2011 and 2021, 3,448 procedures were identified in edoxaban patients, including 287 (8.3%) major procedures. A scheduled interruption of edoxaban was observed in 284/287 major procedures (99%) with a total median edoxaban interruption time of 11.0 days (25–75th percentile: 5.0–18.0 days). Heparin bridging was documented in 183 procedures (46 prophylactic dosages, 111 intermediate and 26 therapeutic dosages). Overall, 7 (2.4%; 95% CI: 1.2–4.9%) major cardiovascular events (5 VTE, 2 arterial thromboembolic events) and 38 major bleedings (13.2%; 95% CI: 9.8–17.7%) were observed and 6 patients died (2.1%; 95% CI: 1.0–4.5%). Rates of major cardiovascular events with or without heparin bridging were comparable (4/137; 2.9%; 95% CI: 1.1–7.3% vs. 3/82; 3.7%; 95% CI: 1.3–10.2%). Major bleedings occurred numerically more frequent in patients receiving heparin bridging (23/137; 16.8%; 95% CI: 11.5–23.9%) versus procedures without heparin bridging (9/82; 11.0%; 95% CI: 5.9–19.6%).

Conclusion Within the limitations of our study design, real-world periprocedural edoxaban management seems effective and safe. Use of heparin bridging seems to have limited effects on reducing vascular events but may increase bleeding risk.

Keywords

anticoagulation - edoxaban - bridging - heparin - major procedures

Ethics

The DRESDEN NOAC REGISTRY is registered at ClinicalTrials.gov (NCT01588119). The study protocol of the Dresden NOAC registry was approved by the local ethics committee at the Technical University Dresden (AZ EK 349092011). All patients gave their written informed consent and signed a data protection waiver before enrolment.


Authors' Contributions

J.B.-W. and L.T. conceived the present analysis and performed the statistical analyses. C.K. wrote the first draft of the manuscript. S.M., C.N. C.K. and J.B.-W. performed the central event adjudication. All authors contributed to the data collection and to the written presentation. All authors critically reviewed the manuscript and approved submission.


Supplementary Material



Publication History

Received: 29 March 2023

Accepted: 26 June 2023

Article published online:
22 September 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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