Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial

• Published in: Diagnostic and interventional imaging 2024-04, Vol.105 (4), p.144-150
• Main Authors: Sapoval, Marc, Querub, Charles, Pereira, Helena, Pellerin, Olivier, Boeken, Tom, Di Gaeta, Alessandro, Ahmar, Marc Al, Lefevre-Colau, Marie-Martine, Nguyen, Christelle, Daste, Camille, Lacroix, Maxime, Laredo, Jean-Denis, Sabatier, Brigitte, Martelli, Nicolas, Chatellier, Gilles, Déan, Carole, Rannou, François
• Format: Article
• Language: English
• Subjects: Aged; Emulsions - therapeutic use; Ethiodized Oil; Female; Human health and pathology; Humans; Life Sciences; Middle Aged; Osteoarthritis, Knee - therapy; Pain; Prospective Studies; Treatment Outcome
• ISSN: 2211-5684; 2211-5684
• DOI: 10.1016/j.diii.2023.12.003

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