Journal of vascular and interventional radiology : JVIR · 2025
A Prospective Single-Arm Trial of Genicular Artery Embolization for Symptomatic Knee Osteoarthritis: Clinical and Biomarker Outcomes.
СтатьяКлиническое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Taslakian Bedros, Mabud Tarub, Attur Mukundan, Alaia Erin F, Samuels Jonathan, Macaulay William, Ramos Danibel, Salami Christiana, Liu Shu, Morris Elizabeth M, Hickey Ryan
Аннотация
PURPOSE: To evaluate the safety and effectiveness of genicular artery embolization (GAE) and its longitudinal effects on biomarkers implicated in knee osteoarthritis (KOA) pathogenesis.
MATERIALS AND METHODS: This was a prospective, single-arm clinical trial of patients with symptomatic KOA resistant to conservative therapy for >3 months. Twenty-five patients who underwent GAE using 250-μm permanent microspheres were enrolled. Patient-reported outcome measures were evaluated at baseline and 1, 3, and 12 months following GAE. Blood samples were collected for biomarker analysis. Magnetic resonance (MR) imaging was performed at baseline and 3 months after GAE. The primary endpoint was the clinical success rate at 12 months, defined as 4 point decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Baseline and follow-up outcomes were analyzed using the Wilcoxon matched-pairs signed-rank test.
RESULTS: The technical success was 100%, with no severe adverse events. The clinical success rate was 62%. The mean visual analog scale pain score for the target knee decreased by 48.5% at 1 month, 50.8% at 3 months, and 55.4% at 12 months (P < .001). WOMAC pain scores improved by 39.6% at 1 month, 50.1% at 3 months, and 43.7% at 12 months (P < .001). There was a statistically significant decrease in the serum levels of vascular endothelial growth factor (VEGF) and interleukin-1 receptor antagonist (IL-1Ra) at 12 months. The remaining biomarkers showed no significant change.
CONCLUSIONS: GAE is a safe treatment for symptomatic KOA, providing clinically significant pain relief for a subset of patients. The observed reductions in serum VEGF and IL-1Ra levels following GAE may contribute to local pain relief and decreased inflammation in the knee joints.
MATERIALS AND METHODS: This was a prospective, single-arm clinical trial of patients with symptomatic KOA resistant to conservative therapy for >3 months. Twenty-five patients who underwent GAE using 250-μm permanent microspheres were enrolled. Patient-reported outcome measures were evaluated at baseline and 1, 3, and 12 months following GAE. Blood samples were collected for biomarker analysis. Magnetic resonance (MR) imaging was performed at baseline and 3 months after GAE. The primary endpoint was the clinical success rate at 12 months, defined as 4 point decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Baseline and follow-up outcomes were analyzed using the Wilcoxon matched-pairs signed-rank test.
RESULTS: The technical success was 100%, with no severe adverse events. The clinical success rate was 62%. The mean visual analog scale pain score for the target knee decreased by 48.5% at 1 month, 50.8% at 3 months, and 55.4% at 12 months (P < .001). WOMAC pain scores improved by 39.6% at 1 month, 50.1% at 3 months, and 43.7% at 12 months (P < .001). There was a statistically significant decrease in the serum levels of vascular endothelial growth factor (VEGF) and interleukin-1 receptor antagonist (IL-1Ra) at 12 months. The remaining biomarkers showed no significant change.
CONCLUSIONS: GAE is a safe treatment for symptomatic KOA, providing clinically significant pain relief for a subset of patients. The observed reductions in serum VEGF and IL-1Ra levels following GAE may contribute to local pain relief and decreased inflammation in the knee joints.