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Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial - 30/03/24

Doi : 10.1016/j.diii.2023.12.003 
Marc Sapoval a, b, ⁎ , Charles Querub a, Helena Pereira c, d, Olivier Pellerin a, b, Tom Boeken a, e, Alessandro Di Gaeta a, Marc Al Ahmar a, Marie-Martine Lefevre-Colau f, g, Christelle Nguyen f, h, Camille Daste f, g, Maxime Lacroix i, Jean-Denis Laredo j, Brigitte Sabatier e, k, l, Nicolas Martelli k, m, Gilles Chatellier c, d, Carole Déan a, François Rannou f, h
a Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Department of Vascular and Oncological Interventional Radiology, 75015 Paris, France 
b Université Paris Cité, PARCC - INSERM Unité-970, 75015 Paris, France 
c INSERM, Centre d'investigation Clinique 1418 Épidémiologie Clinique, 75015 Paris, France 
d Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Clinical Research Unit, 75015 Paris, France 
e HeKA team, INRIA, 75012 Paris, France 
f Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, 75014 Paris, France 
g Université de Paris Cité, INSERM UMR-S 1153, Centre de Recherche Épidémiologie Et Statistique Paris (CRESS), ECaMO Team, 75004 Paris, France 
h Université Paris Cité, INSERM UMR-S 1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, 75006 Paris, France 
i Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Service d'imagerie, 75015 Paris, France 
j Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Service de Chirurgie Orthopédique Et Traumatologique, 75010 Paris, France 
k Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Pharmacie, 75015 Paris, France 
l Université Paris-Saclay, Faculté de Pharmacie, Pharmacie Clinique, 91400 Orsay, France 
m Université Paris-Saclay, Faculté de Pharmacie, GRADES, 91400 Orsay, France 

⁎Corresponding author.

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Highlights

•
Genicular artery embolization is a new treatment for knee osteoarthritis.
•
Genicular artery embolization using an ethiodized oil-based emulsion is safe for the treatment of knee osteoarthritis.
•
Genicular artery embolization improves pain and knee function for at least three months in patients with knee osteoarthritis.

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Abstract

Purpose

The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA).

Materials and methods

This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0–100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria.

Results

Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function.

Conclusion

GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : Ethiodized oil-based emulsion, Genicular artery embolization, Knee osteoarthritis, Pain management, Transient embolic agent

Abbreviations : GAE, KL, KOA, OARSI, OMERACT, SD, VAS, WOMAC


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