Why the study?
The study was designed to investigate the safety and efficacy of edoxaban administered via percutaneous endoscopic gastrostomy in patients with atrial fibrillation requiring long-term anticoagulation.
Does edoxaban administered via PEG provide adequate anticoagulation and safety in fragile patients with atrial fibrillation?
Does edoxaban administered via PEG provide adequate anticoagulation and safety in fragile patients with atrial fibrillation?
Preliminary data suggest that administration of edoxaban via PEG tube in fragile patients with atrial fibrillation achieves adequate steady-state anti-FXa levels without major adverse events.
Answers are grounded in this paper and cite their sources.
Should not change practice for edoxaban via PEG in fragile AF; leaves open need for larger prospective validation.
AIMS: The ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation (ORIGAMI) study investigates the safety and efficacy of Edoxaban administered via PEG in patients with atrial fibrillation and a clinical indication for a long-term anticoagulation. DESIGN: In this prospective, single-centre observational study, 12 PEG-treated patients with indication to anticoagulation will receive edoxaban via PEG and will be followed up to 6 months. Plasma antifactor Xa activity and edoxaban concentrations will be assessed. Thromboembolic (ischaemic stroke, systemic embolism, venous thromboembolism) and bleeding events (Bleeding Academic Research Consortium and Thrombolysis in Myocardial Infarction) will be recorded at 1 and 6 months. PRELIMINARY RESULTS: A retrospective analysis of five atrial fibrillation cases undergoing PEG implantation at our Institution who received edoxaban via PEG showed plasma anti-FXa levels at a steady state of 146 ± 15 ng/ml, without major adverse event at a mean follow-up of 6 months. CONCLUSION: ORIGAMI prospectively investigates PEG-administration of edoxaban in PEG-treated patients requiring long-term anticoagulation. Our preliminary retrospective data support this route of DOAC administration. CLINICALTRIALSGOV IDENTIFIER: NCT04271293.
No takes yet. Share an insight, caveat, or question.
D’Amario et al. (2020) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: