Perioperative Factor Xa Inhibitor Discontinuation for Patients Undergoing Procedures With Minimal or Low Bleeding Risk.

Abstract

Importance: Discontinuation of oral anticoagulant treatment is common in clinical practice due to concerns about bleeding, even for procedures with minimal to low bleeding risk.

Objective: To explore whether perioperative discontinuation of factor Xa inhibitors is associated with major bleeding and thromboembolic events in patients with atrial fibrillation (AF) undergoing procedures with minimal to low bleeding risk.

Design, setting, and participants: This prospective, multicenter, single-arm cohort study conducted in Korea included patients with AF who planned to undergo a procedure with minimal to low bleeding risk between September 25, 2020, and April 5, 2024.

Exposure: The PERIXa (Perioperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Undergoing Minimal to Low Bleed Risk Procedures) protocol recommending giving the last dose of factor Xa inhibitor (ie, apixaban, edoxaban, or rivaroxaban) 24 hours before the procedure (ie, endoscopy, dental procedure, or ocular surgery) and restarting treatment with the inhibitor the next day.

Main outcomes and measures: The primary outcome was major bleeding, and the secondary outcome included a composite of thromboembolic events 30 days after the index procedure with minimal to low bleeding risk.

Results: In total, 1902 patients were included in the modified intention-to-treat analysis set encompassing all patients who underwent the intended procedure (mean [SD] age, 70.4 [8.8] years; 1135 [59.7%] male; mean [SD] CHA2DS2-VASc [congestive heart failure, hypertension, age 75 years or older, diabetes, stroke, vascular disease, age 65-74 years, and female sex; range, 0-9, with higher scores indicating higher risk of stroke] score, 2.8 [1.3]; mean [SD] HAS-BLED [hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age >65 years, and drug or alcohol use; range, 0-9, with higher scores indicating higher risk of bleeding] score, 1.6 [0.7]). Among them, 921 (48.4%) were receiving apixaban, 616 (32.4%) were receiving edoxaban, and 365 (19.2%) were receiving rivaroxaban. Of the total procedures, 948 (49.8%) were endoscopy, 820 (43.1%) were dental procedures, and 120 (6.3%) were ocular surgery. The 30-day event rate of major bleeding was 0.1% (n = 2), and there were no composite thromboembolic events. The results were consistent in the per-protocol analysis, and no differences were observed by procedure category or factor Xa inhibitor type.

Conclusions and relevance: In this cohort study, patients with AF receiving a factor Xa inhibitor and undergoing a procedure with minimal to low bleeding risk had low rates of major bleeding and thromboembolism when following the standardized PERIXa protocol for perioperative management of oral anticoagulant treatment, suggesting that this may be a safe and reasonable option for this patient population.