ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study

Maria Elena Riccioni, Mario Sabatelli, Massimo Antonelli, Felicita Andreotti, Raimondo De Cristofaro, Filippo Crea, Mattia Galli, Francesco Canonico, Alessandra Arcudi, Roberto Scacciavillani, Luigi Cappannoli, Maria Giuseppina Annetta, Rocco Antonio Montone, Antonio Maria Leone, Giampaolo Niccoli, D'Amario 1 Domenico, Attilio Restivo, Gaetano Di Stefano, Carlo Piccinni, Rocco Vergallo

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

Background: Randomized trials support the safety and efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients with nonvalvular atrial fibrillation, leading to increased use of these compounds. Crushed forms of DOACs have been shown to be reliable, but evidence supporting percutaneous endoscopic gastrostomy (PEG) delivery is lacking. PEG is a long-term option for enteral food and drug delivery in patients unable to maintain oral intake, bypassing the risks and disadvantages of parenteral nutrition. 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 cases: 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. CLINICALTRIALS.
Lingua originaleEnglish
pagine (da-a)---
RivistaJournal of Cardiovascular Medicine
Stato di pubblicazionePubblicato - 2020

Keywords

  • ORIGAMI

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