ORIGINAL ARTICLE   

Minerva Cardiology and Angiology 2023 February;71(1):109-16

DOI: 10.23736/S2724-5683.21.05903-2

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Oral anticoagulants in fragile patients with percutaneous endoscopic gastrostomy and atrial fibrillation: the ORIGAMI pilot investigation

Domenico D’AMARIO ^{1, 2} ✉, Mattia GALLI ^{1, 2}, Luigi CAPPANNOLI ², Francesco CANONICO ¹, Attilio RESTIVO ², Alessandra ARCUDI ², Roberto SCACCIAVILLANI ², Maria E. RICCIONI ², Rocco VERGALLO ^{1, 2}, Rocco A. MONTONE ¹, Amelia CONTE ³, Emiliana MELEO ³, Stefano LANCELLOTTI ², Monica SACCO ², Massimo ANTONELLI ^{2, 3, 4}, Felicita ANDREOTTI ^{1, 2}, Raimondo DE CRISTOFARO ^{2, 3, 4, 5}, Filippo CREA ^{1, 2}

¹ Department of Cardiovascular Sciences, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy; ² Sacred Heart Catholic University, Rome, Italy; ³ NEMO Center, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy; ⁴ Department of Emergency Sciences, Anesthesiology and Intensive Care, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy; ⁵ Section of Hemorrhagic and Thrombotic Diseases, Department of Medicine and Translational Surgery, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy

BACKGROUND: Extensive data support the superior safety without any trade-off in efficacy of direct oral anticoagulants (DOACs) compared to vitamin K antagonists (VKA) in patients with nonvalvular atrial fibrillation, deep venous thrombosis or pulmonary embolism. Whether DOACs may be successfully used to treat complex and fragile patients with percutaneous endoscopic gastrostomy (PEG) remains to be proven. The purpose of this pilot study was to evaluate the feasibility, anticoagulant effect, and preliminary safety/efficacy profile of edoxaban administered via PEG in patients with an indication for long-term oral anticoagulation.
METHODS: In this prospective, single-arm, pilot study, 12 patients with PEG and guideline-recommended indication for anticoagulation for nonvalvular atrial fibrillation were prospectively enrolled. Crushed edoxaban at approved doses was administered via PEG. Quantitative measures of edoxaban’s antifactor Xa activity were performed at steady state. Thromboembolic and bleeding events were assessed at one-month follow-up.
RESULTS: Steady state edoxaban plasma levels were at therapeutic range in all patients; mean plasma concentration was 208.5 (±78.6) ng/mL. At one month follow-up, none had suffered a thromboembolic event; one developed minor bleeding, and one died from non-cardiovascular death, owing to sudden worsening of a pre-existing underlying severe condition.
CONCLUSIONS: In this pilot investigation, we report for the first time that crushed edoxaban, administered at approved doses through PEG in fragile and complex patients, is feasible, results in therapeutic edoxaban concentrations, and is apparently effective and safe.

KEY WORDS: Atrial fibrillation; Factor Xa inhibitors; Edoxaban