Four-Year Outcomes of the FEMME Trial Demonstrate Effectiveness of Both UAE and Myomectomy for Symptomatic Uterine Fibroids

KEY FINDINGS

• The greater improvement in health-related QOL seen with myomectomy at 2-year follow-up as compared with UAE had decreased by 4-year follow-up and was no longer statistically significant.
• The cumulative repeat procedure rate was higher in the UAE group (24%) versus the myomectomy group (13%).
• There was no statistically significant difference in menstrual bleeding scores between groups.
• Conclusions could not be drawn on pregnancy outcomes due to small sample size.

ENDOVASCULAR TODAY ASKS…

Study investigators Jane Daniels, PhD, and Anna-Maria Belli, MBBS, provided some insight into the study methods and clinical implications of the results.

Dr. Daniels, what was the process for deciding the primary and secondary outcomes of this study?

Dr. Daniels: Uterine fibroids impact women in a number of ways, including heavy menstrual bleeding, feelings of abdominal bulkiness, and subfertility. We wanted to capture the burden of symptoms and their impact on overall QOL, and the validated UFS-QOL scale does this well. We chose other outcomes that reflected what are important to women, including menstrual bleeding, length of hospital stay, and the need for repeat procedures. We knew not every participant would be seeking to get pregnant, but collecting blood and measuring certain hormones would provide useful information about the impact of either procedure on ovarian reserve.

Prof. Belli, how would you contextualize the relevance of the repeat procedure rate, which was higher in the UAE group? Are there any adjustments or innovation needed for UAE that could further improve its effectiveness?

Prof. Belli: UAE leaves the fibroids in situ, and unless the fibroid is completely infarcted, there is always the risk of regrowth until the woman reaches menopause. The problem is that the operator can only tell if the fibroid has been infarcted in retrospect on follow-up imaging. What is needed is a real-time investigation during the embolization procedure that can indicate when total infarction of the fibroids has occurred. There is research in this area, but the practicalities in large, multifibroid uteri make this a difficult undertaking in the real world. In the meantime, all interventional radiologists can do is to look carefully at their embolization techniques to determine which give the best infarction rates.

Prof. Belli, the article concludes that patient satisfaction for both procedures was high, with no clinically significant differences in QOL between the two groups at 4 years. How do these results translate to clinical practice in terms of decision-making between the two treatments? And, what factors other than QOL should patients and physicians consider when seeking and deciding on treatment?

Prof. Belli: The results demonstrate that both treatment options are valid and effective and should be offered to women with symptomatic fibroids. Once women are informed of the relative advantages and disadvantages of each treatment, they can select the treatment that suits them best. If short recovery time and a desire to avoid surgery is important to them, then UAE may be preferred. A woman’s body image is an important factor, and some women wish for a flatter abdominal silhouette as well as symptomatic relief or do not like the idea of the fibroids remaining in situ, in which case myomectomy might be preferred. Although the numbers of women becoming pregnant was too small to draw conclusions, the fact that there was no difference in the impact of treatment on ovarian reserve suggests that the desire for pregnancy should not be considered a deterrent for UAE.

Dr. Daniels, the study sought to assess pregnancy outcomes, but the sample size was too small to draw any conclusions. How would you go about assessing these outcomes in a future trial?

Dr. Daniels: An adequately powered randomized trial including slightly younger women who are seeking pregnancy (spontaneously or by assisted reproduction) is required but will be challenging. A comparable trial to the FEMME trial, specifically for women with fibroids and no other infertility factors, commenced in France (NCT02577055); however, this trial struggled to recruit in the face of the same concerns regarding the impact of UAE on ovarian function and was terminated after 15 participants were enrolled.¹ The lack of compelling evidence for adverse effects of myomectomy and UAE from the FEMME trial and other sources² should reduce the barriers to a new randomized trial.

1. Torre A, Fauconnier A, Kahn V, et al. Fertility after uterine artery embolization for symptomatic multiple fibroids with no other infertility factors. Eur Radiol. 2017;27:2850-2859. doi: 10.1007/s00330-016-4681-z

2. El Shamy T, Amer SAK, Mohamed AA, et al. The impact of uterine artery embolization on ovarian reserve: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2020;99:16-23. doi: 10.1111/aogs.13698