
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.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.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.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.Clinicaltrials.gov: NCT05801068.
Time Factors, perioperative care, Pyridones, Pyridines, Administration, Oral, Hemorrhage, direct factor Xa inhibitor, Risk Assessment, Perioperative Care, Drug Administration Schedule, Perioperative Care/methods, Study Protocol, Rivaroxaban, Pyridones/adverse effects, oral anticoagulant, Risk Factors, Hemorrhage/chemically induced, Pyrazoles/adverse effects, Atrial Fibrillation, Atrial Fibrillation/diagnosis, Humans, Multicenter Studies as Topic, atrial fibrillation, Prospective Studies, Registries, Factor Xa Inhibitors/adverse effects, Pyridines/adverse effects, Rivaroxaban/adverse effects, bleeding, Thiazoles, Treatment Outcome, Research Design, Pyrazoles, Factor Xa Inhibitors
Time Factors, perioperative care, Pyridones, Pyridines, Administration, Oral, Hemorrhage, direct factor Xa inhibitor, Risk Assessment, Perioperative Care, Drug Administration Schedule, Perioperative Care/methods, Study Protocol, Rivaroxaban, Pyridones/adverse effects, oral anticoagulant, Risk Factors, Hemorrhage/chemically induced, Pyrazoles/adverse effects, Atrial Fibrillation, Atrial Fibrillation/diagnosis, Humans, Multicenter Studies as Topic, atrial fibrillation, Prospective Studies, Registries, Factor Xa Inhibitors/adverse effects, Pyridines/adverse effects, Rivaroxaban/adverse effects, bleeding, Thiazoles, Treatment Outcome, Research Design, Pyrazoles, Factor Xa Inhibitors
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