Routine clinical practice in the periprocedural management of edoxaban therapy is associated with low risk of bleeding and thromboembolic complications: The prospective, observational, and multinational EMIT‐AF/VTE study

• Published in: Clinical cardiology (Mahwah, N.J.) Vol. 43; no. 7; pp. 769 - 780
• Main Authors: Colonna, Paolo, Heymann, Christian, Santamaria, Amparo, Saxena, Manish, Vanassche, Thomas, Wolpert, Diana, Laeis, Petra, Wilkins, Robert, Chen, Cathy, Unverdorben, Martin
• Format: Journal Article
• Language: English
• Published: New York Wiley Periodicals, Inc 01.07.2020; John Wiley & Sons, Inc
• Subjects: Acute coronary syndromes; Adult; Age; Anticoagulants; Anticoagulants - therapeutic use; atrial fibrillation; Atrial Fibrillation - drug therapy; Atrial Fibrillation - surgery; bleeding; Cardiovascular disease; Catheter Ablation; Clinical Investigations; Confidence intervals; Diabetes; Drug dosages; edoxaban; Factor Xa Inhibitors - therapeutic use; Female; Hemorrhage - chemically induced; Humans; Hypertension; Male; Middle Aged; NOAC; Patients; Perioperative Period; periprocedural management; Prevention; Prospective Studies; Pyridines - therapeutic use; Stroke; Studies; Thiazoles - therapeutic use; Thromboembolism; Thromboembolism - chemically induced; Thrombosis; Treatment Outcome; venous thromboembolism; New York; atrial fibrillation; bleeding; venous thromboembolism; edoxaban; NOAC; periprocedural management
• ISSN: 0160-9289; 1932-8737; 1932-8737
• DOI: 10.1002/clc.23379

Background Guidance for periprocedural anticoagulant management is mainly based on limited data from Phase III or observational studies and expert opinion. Hypothesis EMIT‐AF/VTE was designed to document the risks of bleeding and thromboembolic events in more than 1000 patients on edoxaban undergoing diagnostic and therapeutic procedures in clinical practice. Methods Routine care in a multinational multicenter, prospective observational study. Participants were adult patients with atrial fibrillation and/or venous thromboembolism treated with edoxaban for stroke prevention or for secondary prevention in venous thromboembolic disease, undergoing a wide range of diagnostic and therapeutic procedures. Edoxaban therapy was interrupted periprocedurally at the treating physician's discretion. Patients were evaluated from 5 days pre‐ until 30 days postprocedure. Primary outcome was the incidence of International Society on Thrombosis and Haemostasis defined major bleeding; secondary outcomes included incidence of clinically relevant non‐major bleeding, acute coronary syndrome, and acute thromboembolic events. Results Outcomes and management are reported for the first procedures in 1155 unselected patients. Five cases of major bleeding (0.4%) and eight of clinically relevant non‐major bleeding (0.7%) were documented, five (38%) of which occurred outside the period of likely edoxaban effect (last edoxaban dose ≥3 days prior to bleeding). Five (0.4%) deaths from any cause, seven acute thromboembolic events (0.6%) including two cardiac deaths (0.2%) in six patients, and one acute coronary event (0.1%) occurred. Conclusions The periprocedural bleeding and acute thromboembolic event risks for patients treated with edoxaban were low. This can help inform both clinical routine and guidelines for the periprocedural management of edoxaban.