AUTHOR=Cappannoli Luigi , Laborante Renzo , Galli Mattia , Canonico Francesco , Ciliberti Giuseppe , Restivo Attilio , Princi Giuseppe , Arcudi Alessandra , Sabatelli Mario , De Cristofaro Raimondo , Crea Filippo , D’Amario Domenico 

TITLE=Feasibility, effectiveness, and safety of edoxaban administration through percutaneous endoscopic gastrostomy: 12-months follow up of the ORIGAMI study

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1052053

DOI=10.3389/fcvm.2022.1052053

ISSN=2297-055X

ABSTRACT=Background and aims. Edoxaban proved to be safe and effective also in fragile patients, but its administration thorough percutaneous endoscopic gastrostomy (PEG) has not been previously investigated. The purpose of this study was to evaluate the feasibility and the preliminary safety and efficacy profiles of edoxaban administered via PEG in patients with an indication for long-term oral anticoagulation. 
Methods. ORIGAMI was a prospective, single-arm, observational study (NCT04271293). Patients with PEG and an indication for long-term anticoagulation were prospectively enrolled. Crushed edoxaban at approved doses was administered via PEG. The primary endpoint was the composite of cardio-embolic events consisting of ischemic stroke, systemic embolism or symptomatic deep venous thrombosis/pulmonary embolism (DVT/PE). Secondary endpoints were the number of bleeding events, and edoxaban plasma concentrations at steady state. We here report the 12-month results. 
Results: A total of 12 patients were enrolled. The main indication for PEG implantation was amyotrophic lateral sclerosis (10/12). The primary endpoint of cardio-embolic events did not occur in any patients at 12-month. All patients were in the therapeutic range of steady state edoxaban plasma levels. Three minor bleeding and no major bleedings were recorded. A total of five patients died. All deaths were from non-cardiovascular causes and were consistent with the natural history of the pre-existing severe disease.
Conclusions. Our study suggests that edoxaban administration via PEG is feasible and apparently safe and effective in fragile, comorbid patients, resulting in in therapeutic plasma concentrations of edoxaban.