Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial

Abstract

Objective To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported. Study Design Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization. Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance. The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes. Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394 Results 254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI −1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18–1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27–1.05). Conclusions Myomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.

Effects on heavy menstrual bleeding and pregnancy of uterine artery embolization (UAE) or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: The FEMME randomized controlled trial

“…The health‐related QOL score at 2 years of follow‐up was the primary time point. The data have been reported elsewhere 17,19 . The primary analyses were by ITT.…”

Uterine artery embolisation: fertility, adenomyosis and size – what is the evidence?

“…Following our literature search and applying our exclusion criteria, a total of 17 studies were included for further analysis, which are summarised in Table 2 (Mara et al 2008 ; Daniels et al 2021 ; Holub et al 2008 ; Mara et al 2012 ; McLucas et al 2001 ; Pron et al 2005 ; Kim et al 2008 ; Pinto Pabón et al 2008 ; McLucas 2013 ; Pisco et al 2017 ; Torre et al 2017 ; Walker and McDowell 2006 ; Hirst et al 2008 ; Bonduki et al 2011 ; Serres-Cousine et al 2021 ; Ravina et al 2000 ; Firouznia et al 2009 ; Redecha Jr et al 2013 ). Our analysis found a mean pregnancy rate of 39.4%, live birth rate of 69.2% and miscarriage rate of 22% (Table 2 ).…”

“…Of the studies included in the analysis there were two RCTs which compared outcomes following UAE and myomectomy (Mara et al 2008 ; Daniels et al 2021 ). Mara et al ( 2008 ) found pregnancy rates of 50% in the UAE cohort (26 patients) compared to 78% in the myomectomy (either open or laparoscopic) cohort (40 patients).…”

“…A more recent RCT published by Daniels et al ( 2021 ), compares UAE and myomectomy with a 4-year follow up period. They report a cumulative pregnancy rate of 15% (compared to 6% in the myomectomy cohort).…”

Current Strategies for Prevention of Infection After Uterine Artery Embolisation

“…UAE offers several advantages in comparison to surgical options (myomectomy or hysterectomy), including shorter average length of hospital stay, shorter recovery period, similar rates of symptomatic improvement, retention of the uterus, and no requirement for general anaesthesia [1][2][3][4][5][6][7][8][9]. However, UAE has slightly higher rates of long-term reintervention compared to hysterectomy [1][2][3][4][5][6][7][8][9], and a recent randomised controlled trial suggested that myomectomy may provide better symptomatic improvement after 2 years, but likely not at 4 years [13,14]. While UAE is a safe and low-risk procedure, infective complications do occur, which may require hysterectomy (0.4-0.7%) if not resolved with intravenous (IV) antibiotics alone [15][16][17][18][19][20].…”