Division of Vascular and Interventional Radiology, Department of Radiology, NYU Langone Health, New York, New York.
Division of Vascular and Interventional Radiology, Department of Radiology, NYU Langone Health, New York, New York.
J Vasc Interv Radiol. 2023 Dec;34(12):2180-2189.e3. doi: 10.1016/j.jvir.2023.08.029. Epub 2023 Aug 26.
To characterize the safety, efficacy, and potential role of genicular artery embolization (GAE) as a disease-modifying treatment for symptomatic knee osteoarthritis (OA).
This is an interim analysis of a prospective, single-arm clinical trial of patients with symptomatic knee OA who failed conservative therapy for greater than 3 months. Sixteen patients who underwent GAE using 250-μm microspheres and had at least 1 month of follow-up were included. Six patients completed the 12-month follow-up, and 10 patients remain enrolled. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was evaluated at baseline and at 1, 3, and 12 months. Serum and plasma samples were collected for biomarker analysis. The primary end point was the percentage of patients who achieved the minimal clinically important difference (MCID) for WOMAC pain score at 12 months. Baseline and follow-up outcomes were analyzed using the Wilcoxon matched-pairs signed-rank test.
Technical success of the procedure was 100%, with no major adverse events. The MCID was achieved in 5 of the 6 (83%) patients at 12 months. The mean WOMAC pain score decreased from 8.6 ± 2.7 at baseline to 4.9 ± 2.7 (P = .001), 4.4 ± 2.8 (P < .001), and 4.7 ± 2.7 (P = .094) at 1, 3, and 12 months, respectively. There was a statistically significant decrease in nerve growth factor (NGF) levels at 12 months. The remaining 8 biomarkers showed no significant change at 12 months.
GAE is a safe and efficacious treatment for symptomatic knee OA. Decreased NGF levels after GAE may contribute to pain reduction and slowing of cartilage degeneration.
描述内侧膝关节炎（OA）患者行膝关节分支动脉栓塞术（GAE）治疗的安全性、有效性和潜在作用，该治疗方法可能对膝关节 OA 具有改善病情的作用。
这是一项单臂前瞻性临床试验的中期分析，研究对象为经大于 3 个月的保守治疗后症状仍未缓解的膝关节 OA 患者。共纳入 16 例行 GAE 治疗（使用 250μm 微球）且至少随访 1 个月的患者。其中 6 例患者完成 12 个月随访，10 例患者仍在随访中。于基线和 1、3、12 个月时采用 Western Ontario and McMaster Universities Osteoarthritis Index（WOMAC）评估患者。采集血清和血浆样本进行生物标志物分析。主要终点为 12 个月时 WOMAC 疼痛评分达到最小临床重要差异（MCID）的患者比例。采用 Wilcoxon 配对符号秩检验分析基线和随访结果。
该操作技术成功率为 100%，无重大不良事件。6 例患者中有 5 例（83%）在 12 个月时达到 MCID。WOMAC 疼痛评分从基线时的 8.6±2.7 分降至 1 个月时的 4.9±2.7 分（P=0.001）、3 个月时的 4.4±2.8 分（P<0.001）和 12 个月时的 4.7±2.7 分（P=0.094），差异均有统计学意义。神经生长因子（NGF）水平在 12 个月时呈统计学显著下降。其余 8 种生物标志物在 12 个月时无明显变化。
GAE 治疗膝关节 OA 安全且有效。GAE 后 NGF 水平降低可能有助于减轻疼痛和减缓软骨退化。
