The results of the FUME trial, the first randomised trial comparing uterine artery embolization and myomectomy with regard to quality of life outcomes, show that both procedures result in significant and equal improvements in the quality of life of patients at two years. While embolization allows a shorter hospital stay and is associated with fewer major complications, it also has a higher re-intervention rate.
Isaac Manyonda, Anna Maria Belli and colleagues from St Georges Healthcare NHS Trust, London, UK, have published their results in the August issue of CardioVascular and Interventional Radiology.
The investigators randomised women with symptomatic fibroids diagnosed by ultrasound who wished to preserve their uterus to myomectomy (n=81) or embolization (n=82). They used a validated questionnaire to measure quality of life as an endpoint. Other endpoints included hospital stay, rates of complications, and need for re-intervention.
Results of the study show that patients who underwent uterine artery embolization had shorter hospitalisation (two vs. six days, p< 0.001). The investigators also note that by one year after the intervention, significant and equal improvements in quality of life scores had occurred in both groups (myomectomy n=59; embolization n=61).
In terms of complications, investigators reported two (2.9%) major complications in the patient group which received embolization vs. six (8%) among those who received myomectomy but this was not a significant difference.
By the two-year mark, in the patients who received embolization (n=57), there were eight (14%) re-interventions for inadequate symptom control compared with one (2.7%) seen in the myomectomy patients (n=37). Authors of the study noted that half of the women who needed a hysterectomy had concomitant adenomyosis which had been missed by ultrasound.
Belli said: “The need for re-intervention after embolization might be seen as its Achilles’ heel, but I think this will be common to all uterus preserving techniques. Even though our trial showed a much lower re-intervention rate after myomectomy at two years, we know that new fibroid growth occurs after myomectomy too. We need a much bigger trial with longer follow-up of at least five years to properly compare the outcomes. The FEMME trial is due to start (This is a multicentre National Institute for Health research [NIHR] UK trial comparing uterine artery embolization and myomectomy.) We have also learned a lot about the need to fully infarct fibroids with embolization which makes a difference to fibroid re-growth rates.”
Belli told Interventional News, “It is very important to compare uterine preserving procedures with each other. Many women wish to avoid a hysterectomy for whatever reason and they need to understand which of the uterine-preserving procedures would best suit their needs with regard to future fertility, post-procedural mobility and return to work, complications as well as the relative rates of re-intervention and other factors.
When asked how she would choose between uterine artery embolization and myomectomy for a young woman who wished to preserve her uterus, Belli said, “As clinicians, we can advise a woman which options are suitable for her and present her with information, but then the choice should be hers depending on which outcomes she considers most important. Most women are suitable for either treatment.”