A 4-year follow-up of a randomized control study comparing uterine artery embolization (UAE) to myomectomy for treating women with uterine fibroids has concluded that myomectomy achieves greater improvement in quality of life.
However, by 4 years, this difference was not statistically significant.1
The analysis in the European Journal of Obstetrics & Gynecology and Reproductive Biology: X is 4-year follow-up data from the author’s Fibroids with Embolization or Myomectomy to Measure the Effect on quality of life among women wishing to avoid hysterectomy (FEMME) study.
Previously, the authors presented 2-year follow-up data from the FEMME study in 2020 in The New England Journal of Medicine.
The original study design comprised 254 premenopausal women with symptomatic uterine fibroids conducive to myomectomy or uterine artery embolization who were recruited from 29 hospitals in the United Kingdom between February 2012 and May 2015.
The women had an average age of 41, and all were classified as overweight by their body mass index (BMI). Overall, 48% of participants in both treatment groups sought pregnancy.
The women were randomized to myomectomy or UAE in a 1:1 ratio.
Myomectomy constituted open abdominal, laparoscopic or hysteroscopic, according to clinician preference.
Embolization of the uterine arteries was performed based on local practice and under fluoroscopic guidance.
The primary outcome measure of the analysis was the Uterine Fibroid Symptom and health-related Quality of Life questionnaire (UFS-QoL), adjusted for baseline score and reported at 4 years post-randomization.
Among secondary findings were subsequent procedures for fibroids, pregnancy and outcome.
Of the 127 women randomized to myomectomy, 105 actually underwent the procedure, and 98 of the 127 women randomized to UAE had embolization.
At 4 years, 53% of the UAE group and 64% of the myomectomy group completed UFS-QoL quality of life scores.
The mean health-related quality-of-life score was 86.6 in the UAE group and 90.2 in the myomectomy group, for a mean difference of 5.0 points, which favored myomectomy: 95% CI: 1.4 to 11.5 (P = 0.13).
Similarly, the mean severity score was 18.8 in the UAE group and 14.5 in the myomectomy group.
There were also 15 pregnancies in the UAE group compared to 7 in the myomectomy group, for a cumulative pregnancy rate over 4 years of 15% and 6% respectively: hazard ratio (HR) = 0.48; 95% CI: 0.18 to 1.28.
“Women desiring pregnancy should be provided with the evidence generated from the FEMME trial, for although the impact of myomectomy and UAE on fertility remains uncertain, there was no evidence of any material difference between the levels of hormones associated with ovarian reserve in each group at 12 months post-procedure,” wrote the authors.
The cumulative repeat procedure rate out to 4 years was 24% in the UAE group and 13% in the myomectomy group: HR = 0.53; 95% CI: 0.27 to 1.05.
In addition, the EuroQoL five-dimension questionnaire (EQ-5D) score was 0.79 in the UAE group and 0.90 in the myomectomy group, for a mean difference of 0.13: 95% CI: 0.06 to 0.20.
The authors noted that missing data may limit the generalizability of results. The number of women becoming pregnant was also too few to surmise the effect of the two procedures on fertility.