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

Massimo Antonelli, Felicita Andreotti, Raimondo De Cristofaro, Filippo Crea, Domenico D'Amario, Mattia Galli, Luigi Cappannoli, Francesco Canonico, Attilio Restivo, Alessandra Arcudi, Roberto Scacciavillani, Rocco Vergallo, Emiliana Meleo, Monica Sacco, Maria E Riccioni, Rocco A Montone, Amelia Conte, Stefano Lancellotti

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

Abstract 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 anti-factor 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.
Lingua originaleEnglish
pagine (da-a)N/A-N/A
RivistaMinerva Cardiology and Angiology
Stato di pubblicazionePubblicato - 2022

Keywords

  • Oral anticoagulants

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