Perioperative Management in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Minor Bleeding Risk Procedure: Rationale and Protocol for the PERIXa Study

Soonil Kwon,1,* So-Ryoung Lee,2,3,* Eue-Keun Choi,2,3 Kyung-Yeon Lee,2 JungMin Choi,2 Hyo-Jeong Ahn,2 Seil Oh,2,3 Gregory Yoke Hong Lip2– 5 1Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; 2Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea; 3Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; 4Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Chest & Heart Hospital, Liverpool, UK; 5Department of Clinical Medicine, Aalborg University, Aalborg, Denmark*These authors contributed equally to this workCorrespondence: Eue-Keun Choi, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea, Tel +82-2-2072-0688, Fax +82-2-762-9662, Email choiek17@snu.ac.krBackground: While treatment interruption of non-vitamin K antagonist oral anticoagulants (NOACs) for elective surgery or procedures among patients with atrial fibrillation (AF) is becoming more prevalent, there remains insufficient evidence regarding the optimal perioperative management of NOACs, particularly procedures with minor bleeding risks.Objective: This study aims to evaluate the safety and effectiveness of a simplified, standardized protocol for perioperative management of direct factor Xa inhibitors in patients, with AF undergoing procedures associated with minor bleeding risk.Methods: This multicenter, prospective single-arm registry study plans to enroll patients undergoing procedures with minor bleeding risk who were prescribed direct factor Xa inhibitors for AF. The procedures with minor bleeding risk will include gastrointestinal endoscopy for diagnostic purposes, selected dental procedures, and ocular surgery for cataracts or glaucoma. For apixaban, patients will withhold the last evening dose and resume either from the evening dose of the procedure day or the following morning, depending on the bleeding risk of the patient. For edoxaban or rivaroxaban, patients will withhold only a single dose on the procedure day. The primary outcome is the occurrence of major bleeding events within 30 days. Secondary outcomes include systemic thromboembolism, all-cause mortality, and a composite of major and clinically relevant non-major bleeding events.Conclusion: This study has the potential to generate evidence regarding the safety of perioperative management for patients, with AF undergoing procedures associated with minor bleeding risk.Trial Registration: Clinicaltrials.gov: NCT05801068.Keywords: atrial fibrillation, direct factor Xa inhibitor, bleeding, oral anticoagulant, perioperative care