Periinterventional management of edoxaban in major procedures: results from the DRESDEN NOAC REGISTRY

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

Method Using data from the prospective DRESDEN NOAC REGISTRY we extracted data on major surgical procedures in patients who took edoxaban within the preceding 7 days. Periinterventional edoxaban management patterns and rates of outcome events were evaluated until day 30 after procedure.

Results Between 2011 and 2021, 3448 procedures were identified in edoxaban patients, including 287 (8.3%) major procedures. Overall, patient characteristics were comparable for major and non-major procedures, but significant differences existed with regard to gender, concomitant antiplatelet therapies and the proportion of patients with a CHA2DS2-VASc score ≥2 ([Table 1]).

Major procedures consisted of orthopaedic/trauma surgery (44.3%); open pelvic, abdominal or thoracic surgery (30.4%), central nervous system surgery and procedures (13.9%), vascular surgery (9.1%) and extensive wound revision surgery (2.4%).

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) occurred and 63 bleeding events were observed in 287 major procedures (22.0%; 95%-CI 17.6%-2.71%), comprising of 38 ISTH major bleeding events (13.2%; 95%-CI 9.8%-17.7%) and 25 ISTH CRNM bleedings (8.7%; 95%-CI 6.0%-12.5%).

Rates of major cardiovascular events with or without heparin bridging were comparable (6/183; 3.3%; 95%-CI 1.5%-7.0% vs. 1/36; 2.8%; 95%-CI 0.5%-14.2%; p=0.7173). ISTH major bleeding occurred numerically more frequent in patients receiving heparin bridging (30/183; 16.4%; 95%-CI 11.7%-22.4%) versus procedures without heparin bridging (2/36; 5.6%; 95%-CI 1.5%-18.1%; p=0.1542) ([Fig. 1]). Within 30 days of follow up, 6 patients died (2.1%; 95%-CI 1.0%-4.5%) with causes of death being a ruptured truncus coeliacus following palliative angioplasty for an infiltrating pancreas cancer (ruled as fatal bleeding), septic organ failure, pneumocystis jirovecii pneumonia, COVID-19-pneumonia, septic complications following clipping of a ruptured cerebrovascular aneurism or terminal malignant disease. No fatal cardiovascular event occurred.

Fig. 1 Time-frequency-plot of periprocedural edoxaban management and heparin bridging; Time-frequency-plot of major cardiovascular outcomes, ISTH major bleeding and death in relation to periprocedural edoxaban management and heparin bridging. Of note, the figure depicts only patients who developed clinical outcomes of interest.

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

Tab. 1  Patient characteristics at baseline of patients with edoxaban undergoing 3448 surgical or I; ^* Impaired renal function was defined as current or history of GFR <50 ml/min.; BMI = body mass index; PAD/CAD = peripheral arterial occlusive disease/coronary artery disease; SPAF = stroke prevention in atrial fibrillation; TIA = transient ischaemic attack; VTE = venous thromboembolism

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Artikel online veröffentlicht:
20. Februar 2023