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

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

doi:10.23736/s2724-5683.21.05903-2

Cited by 2 publications

(3 citation statements)

References 25 publications

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“…As previously discussed, we recognize that this study presents several limitations (11). First, it was a non-randomized, single-arm study.…”

Section: Discussionmentioning

confidence: 90%

“…Edoxaban 60 mg was administered in one patient, while a reduced dose of 30 mg was administered in 11 patients, due to reduced eGFR (5/12) or low body weight (6/12). A detailed description of patients’ characteristics has been reported previously ( 11 ) and in Table 2 .…”

Section: Resultsmentioning

confidence: 99%

“…The materials and methods of ORIGAMI (ORal anti-coagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation) pilot study were previously described ( 10 , 11 ). Briefly, ORIGAMI was a prospective, single-arm, observational, pilot study.…”

Section: Methodsmentioning

confidence: 99%

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

Cappannoli

Laborante

Galli

et al. 2022

Front. Cardiovasc. Med.

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Background and aimsEdoxaban proved to be safe and effective also in fragile patients, but its administration through 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.MethodsORIGAMI 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.ResultsA 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 months. All patients were in the therapeutic range of steady-state edoxaban plasma levels. Three minor bleedings were observed, while no major bleedings occurred during the observational period. 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.ConclusionOur study suggests that edoxaban administration via PEG is feasible and appears safe and effective in fragile, comorbid patients, resulting in therapeutic plasma concentrations of edoxaban.Clinical trial registration[ClinicalTrials.gov], identifier [NCT04271293].

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“…As previously discussed, we recognize that this study presents several limitations (11). First, it was a non-randomized, single-arm study.…”

Section: Discussionmentioning

confidence: 90%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

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

Cappannoli

Laborante

Galli

et al. 2022

Front. Cardiovasc. Med.

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Net clinical benefit of anticoagulant therapy from a neurologist's perspective: A review

Кулеш

2022

Consilium Medicum

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In this article the concept of "net clinical benefit" (NCB) is considered in the context of stroke, the role of direct oral anticoagulants in secondary prevention of cardioembolic stroke and NCB from their prescription. Practical aspects of NCB evaluation from the neurologist's point of view are presented, taking into account such factors as stroke duration and severity, features of neurological deficit (severity of residual limitations, dysphagia, motor disorders and risk of falls), neuroimaging characteristics of stroke (focal size and hemorrhagic transformation) and concomitant neurological diseases (epilepsy and dementia). In all these situations, the use of oral anticoagulants has a significant clinical benefit, which justifies the inadmissibility of refusal to prescribe them.

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

Cited by 2 publications

References 25 publications

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

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

Net clinical benefit of anticoagulant therapy from a neurologist's perspective: A review

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