Vasc Health Risk Manag. 2024;20:231-244.

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.

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제1저자 권순일, 이소령 · 교신저자 최의근

PMID 38774425 PMC11107937 DOI 10.2147/VHRM.S455530 IF 3.2 순환기내과

소속 (5)

Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Chest & Heart Hospital, Liverpool, UK.
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.

Abstract

BACKGROUND 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 fibrillationbleedingdirect factor Xa inhibitororal anticoagulantperioperative care

Figures

**Figure 2** The protocol for stopping and resuming direct factor Xa inhibitors during the perioperative period.

**Figure 3** The flowchart of the study.

그림 출처: PubMed Central 공개 논문 (PMC11107937)

Conflict of interest statement

EKC: Research grants or speaking fees from Abbott, Bayer, BMS/Pfizer, Biosense Webster, Chong Kun Dang, Daewoong Pharmaceutical Co., Daiichi-Sankyo, DeepQure, Dreamtech Co., Ltd., Jeil Pharmaceutical Co., Ltd., Medtronic, Samjinpharm, Seers Technology, and Skylabs. GYHL: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Anthos and Daiichi-Sankyo. No personal fees were received. The co-principal investigator of the AFFIRMO project on multimorbidity in AF received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 899871. The authors report no conflicts of interest in this work.

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