Management of Edoxaban Therapy in Patients Undergoing Major Surgery: A Sub-Analysis of the Prospective, Observational, Multinational Emit-AF/VTE Study

Abstract Introduction Periprocedural management of patients on direct oral anticoagulants (DOAC) undergoing major surgical procedures is mainly based on pharmacokinetic considerations, clinical experience as described in the Dresden Registry (Beyer-Westendorf et al. Eur Heart J. 2014;35: 1888-186.) and the PAUSE study (Douketis JD et al. JAMA Intern Med. 2019;2019;179:1469-78), and on expert opinion. The objective of this study was to describe the background characteristics, periprocedural management, and outcomes of patients taking edoxaban who underwent major surgery in routine clinical practice. Methods Patients evaluated were participants in the EMIT AF/ VTE study (Colonna P et al. Clin Cardiol. 2020 Jul;43:769-80) which analyzed data on the risks of bleeding and thromboembolic events in 1,479 patients taking edoxaban who underwent unselected diagnostic or therapeutic procedures in routine clinical practice. Patients undergoing major surgery were compared with those who underwent non-major surgery. Physicians directed management of edoxaban, especially for dosing interruption, in accordance with locally approved labelling and guidelines such as those of the European Heart Rhythm Association (EHRA). Patients were evaluated from five days before until 29 days after the procedure. The primary outcome was the incidence of major bleeding as defined by the International Society on Thrombosis and Haemostasis; secondary outcomes included the incidence of clinically relevant non-major bleeding (CRNM), acute coronary syndrome (ACS), acute thromboembolic events (ATE) as well as the perioperative interruption times and use of bridging agents. Results Of the 1,478 patients, 128 (8.7%) underwent major-surgery as defined in the Dresden registry and PAUSE study. Background characteristics are summarized in Table 1 and medical history in Table 2. Surgeries by medical specialties are listed in Table 3. Major surgery vs non-major surgery patients had more often atrial fibrillation and dyslipidemia and exhibited higher CHA 2DS 2-VASc and HAS-BLED scores. Peri-procedurally, heparin was used significantly more often in patients with major surgery vs non-major surgery (42/128 (32%) vs 142/1351 (10.5%), p<0.001). Outcomes are summarized in Table 4. There were no significant differences in severe adverse outcomes between the two groups. Pre-procedural and post procedural interruption of edoxaban was longer in the major surgery group. See Table 5. Discussion The edoxaban interruption pattern was statistically different between major and non-major surgery patients. The rates of peri-procedural bleeding and acute thromboembolic events were low when patients were managed according to a clinical experience-driven management protocol. This is in line with the results in prior publications evaluating other direct oral anticoagulants. These results are important to optimize clinical management of patients undergoing elective procedures and will help to support guidelines for the peri-procedural management of edoxaban. Figure 1 Figure 1. Disclosures von Heymann: Daiichi Sankyo: Honoraria, Research Funding; Bayer AG: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria, Research Funding; CSL Behring: Honoraria, Research Funding; NovoNordisk Pharma: Honoraria, Research Funding; Mitsubishi Pharma: Honoraria, Research Funding; Biotest GmbH: Honoraria, Research Funding; Grunenthal GmbH: Honoraria, Research Funding; HICC GbR: Honoraria, Research Funding; German Society of Anaesthesiology and Intensive Care Medicine: Honoraria, Other: Other Mandated to write several guidelines and part of writing groups of guidelines, Research Funding; European Society of Cardiothoracic Anesthesiologists: Other: Other Mandated to write several guidelines and part of writing groups of guidelines; Deutsche Gesellschaft für Gynäkologie und Geburtshilfe: Honoraria, Research Funding; European Society of Anaesthesiology and Intensive Care (ESAIC): Other: Mandated to write several guidelines and part of writing groups of guidelines. Unverdorben: Daiichi Sankyo: Current Employment. Colonna: Boehringer: Honoraria, Research Funding; Bayer: Honoraria, Research Funding; European Society of Cardiology: Other: Mandated to write ESC-Guidelines on AF; Daiichi Sankyo: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria, Research Funding. Ortiz: Bayer: Consultancy; Daiichi Sankyo: Consultancy; Boehringer: Consultancy; Pfizer: Consultancy; Bristol Myers Squibb: Consultancy. Saxena: Recor Medical Inc: Consultancy, Research Funding, Speakers Bureau; Daiichi Sankyo: Consultancy, Research Funding, Speakers Bureau; The Medicines Company: Consultancy, Research Funding, Speakers Bureau; Ablative Solutions Inc: Consultancy, Research Funding, Speakers Bureau; Vascular Dynamics Inc: Consultancy, Honoraria, Speakers Bureau; Esperion Inc: Consultancy, Honoraria, Speakers Bureau; Vifor Pharma: Honoraria, Speakers Bureau. Vanassche: Bayer: Consultancy, Speakers Bureau; Boehringer Ingelheim,: Consultancy, Speakers Bureau; Pfizer/BMS: Consultancy, Speakers Bureau; Daiichi Sankyo: Consultancy, Speakers Bureau. Weitz: Daiichi Sankyo: Consultancy, Speakers Bureau. Wilkins: Daiichi Sankyo: Honoraria. Chen: Daiichi Sankyo: Current Employment.

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