TY - JOUR
T1 - ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study
AU - D'Amario, Domenico
AU - Galli, Mattia
AU - Canonico, Francesco
AU - Restivo, Attilio
AU - Arcudi, Alessandra
AU - Scacciavillani, Roberto
AU - Cappannoli, Luigi
AU - Riccioni, Maria Elena
AU - Annetta, Maria Giuseppina
AU - Di Stefano, Gaetano
AU - Piccinni, Carlo
AU - Vergallo, Rocco
AU - Montone, Rocco Antonio
AU - Leone, Antonio Maria
AU - Niccoli, Giampaolo
AU - Sabatelli, Mario
AU - Antonelli, Massimo
AU - Andreotti, Felicita
AU - De Cristofaro, Raimondo
AU - Crea, Filippo
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - fibrillation
KW - fibrillation
UR - http://hdl.handle.net/10807/176546
U2 - 10.2459/JCM.0000000000001142
DO - 10.2459/JCM.0000000000001142
M3 - Article
SN - 1558-2035
VL - 22
SP - 175
EP - 179
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
ER -