FEMME RCT Results: Myomectomy or Uterine Artery Embolization for Uterine Fibroids?
BACKGROUND AND PURPOSE:
Manyonda et al. (NEJM, 2020) examined outcomes following myomectomy, vs uterine-artery embolization
Multicenter, randomized, open-label trial
A Randomized Trial of Treating Fibroids with Either Embolisation or Myomectomy to Measure the Effect on Quality of Life Among Women Wishing to Avoid Hysterectomy (FEMME Trial)
29 centers in the UK
Symptomatic uterine fibroids
Did not opt for hysterectomy
Open abdominal, laparoscopic, or hysteroscopic
Uterine artery embolization
Randomization balanced for the following
Longest dimension of the largest fibroid (≤7 cm vs. >7 cm) | Number of fibroids (1 to 3 vs. 4 to 10 vs. >10) | Whether pregnancy was desired in the future (yes vs. no)
Quality of life (QOL) assessed with Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire at 2 years
Scores range from 0 to 100 | Higher scores indicating a better quality of life
Analysis was by intention to treat
Fibroid-related quality of life
Total of 254 women
Myomectomy: 127 women (105 underwent the procedure)
Uterine-artery embolization: 127 (98 underwent the procedure)
Primary outcome data were available for 81% of the women (206)
Intention to treat analysis: Myomectomy group reported significantly higher quality of life scores at 2 years
Myomectomy group: 84.6±21.5
Embolization group: 80.0±22.0
Mean adjusted difference with complete case analysis
8.0 points (95% CI, 1.8 to 14.1; P=0.01)
Similar results noted at 6 months and at a year
Perioperative and postoperative complications did not differ between groups (P=0.40)
Myomectomy group: 29%
Embolization group: 24%
Pregnancy reported within 2 years
Myomectomy group: 4%
Embolization group: 8%
Need for additional fibroid-related procedure within 2 years
Myomectomy group: 7%
Embolization group: 16%
Quality of life scores at 2 years were significantly higher in women opting for myomectomy vs uterine-artery embolization
In addition, the authors state
The substantially higher number of surgical reinterventions in the uterine-artery embolization group than in the myomectomy group during 2 years of follow-up may be explained in part by the lower quality of life reported in the uterine-artery embolization group
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