Background There are insufficient data comparing resorbable microspheres (RMs) with permanent trisacryl gelatin microspheres (TAGMs) for uterine artery embolization (UAE). Purpose To compare therapeutic efficacy and clinical outcomes in participants with symptomatic fibroids after UAE with RMs or TAGMs. Materials and Methods This randomized controlled trial included participants undergoing UAE for symptomatic fibroids at a single institution (from May 2021 to May 2023). Participants were randomized one-to-one to undergo UAE with either RMs or TAGMs. Numeric rating scale pain scores and cumulative fentanyl consumption were assessed for 24 hours after undergoing UAE. Anti-Mullerian hormone was measured to assess effects of UAE on ovarian function. MRI was performed before and 3 months after UAE to evaluate fibroid necrosis and uterine artery recanalization. Repeated variables such as pain were analyzed using Mann-Whitney U test with post hoc Bonferroni correction. Results Sixty female participants (mean age, 45.7 years ± 3.6 [SD]) completed the study, with 30 in each group. No evidence of a difference in pain scores was observed between groups (P > .99). Moreover, there was no evidence of a difference in the total fentanyl consumption at 24 hours after UAE between groups (median: RMs, 423 [IQR, 330-530] vs TAGMs, 562 [IQR, 437-780]; P = .15). Serum anti-Mullerian hormone 3 months after UAE showed no evidence of a difference between groups (RMs vs TAGMs, 0.71 ng/mL ± 0.73 vs 0.49 ng/mL ± 0.45, respectively; P = .09). No evidence of a difference in the rate of complete necrosis of the dominant fibroid was observed between groups (97% [29 of 30] for both groups; P > .99). The rate of uterine artery recanalization was higher in RM versus TAGM groups (70% [21 of 30] vs 17% [five of 30], respectively; P < .001). Conclusion UAE with RMs, compared with UAE with TAGMs, showed no evidence of a difference in terms of therapeutic effectiveness or postprocedural pain scores in participants with symptomatic fibroids. Clinical trial registration no. NCT05086770 © RSNA, 2024 See also the editorial by Spies in this issue.

中文翻译：

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可吸收微球与三丙烯酸明胶微球用于子宫动脉栓塞：随机对照试验。


背景 没有足够的数据比较可吸收微球 (RM) 与永久性三丙烯酸明胶微球 (TAGM) 用于子宫动脉栓塞 (UAE) 的情况。目的 比较使用 RM 或 TAGM 进行 UAE 后有症状肌瘤参与者的治疗效果和临床结果。材料和方法 这项随机对照试验包括在同一机构（2021 年 5 月至 2023 年 5 月）因症状性肌瘤而接受 UAE 治疗的参与者。参与者被一对一随机分配接受 RM 或 TAGM 的 UAE 治疗。在接受 UAE 后 24 小时内评估数字评分量表疼痛评分和累积芬太尼消耗量。测量抗苗勒管激素以评估UAE对卵巢功能的影响。在UAE之前和之后3个月进行MRI，以评估肌瘤坏死和子宫动脉再通情况。使用 Mann-Whitney U 检验和事后 Bonferroni 校正对疼痛等重复变量进行分析。结果 60 名女性参与者（平均年龄，45.7 岁 ± 3.6 [SD]）完成了研究，每组 30 人。没有观察到组间疼痛评分存在差异的证据 (P > .99)。此外，没有证据表明UAE后24小时各组之间的芬太尼总消耗量存在差异（中位数：RM，423 [IQR，330-530] vs TAGM，562 [IQR，437-780]；P = .15 ）。 UAE 后 3 个月的血清抗苗勒管激素没有显示组间差异的证据（RM 与 TAGM，分别为 0.71 ng/mL ± 0.73 与 0.49 ng/mL ± 0.45；P = .09）。没有观察到组间显性肌瘤完全坏死率存在差异的证据（两组均为 97% [30 中的 29]；P > .99）。 RM 组与 TAGM 组相比，子宫动脉再通率较高（分别为 70% [30 人中的 21 人] 和 17% [30 人中的 5 人]；P < .001）。结论 与采用 TAGM 的 UAE 相比，UAE 与 RM 相比，没有证据表明有症状肌瘤参与者的治疗效果或术后疼痛评分存在差异。临床试验注册号NCT05086770 © RSNA，2024 另请参阅本期 Spies 的社论。