#Grand Rounds

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

METHODS:

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
Participants
- Symptomatic uterine fibroids
- Did not opt for hysterectomy
Interventions
- Myomectomy
  - Open abdominal, laparoscopic, or hysteroscopic
- Uterine artery embolization
Study design
- 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
Primary outcome
- Fibroid-related quality of life

RESULTS:

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%

CONCLUSION:

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

Learn More – Primary Sources:

Uterine-Artery Embolization or Myomectomy for Uterine Fibroids

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Related ObG Topics:

What Uterine-Sparing Treatment for Fibroids Has the Best Outcomes?

Intervention Comparison for the Treatment of Uterine Fibroids

High-Intensity Ultrasound for Fibroids – What are the Pregnancy Outcomes?

Uterine Artery Embolization or Hysterectomy for Fibroids?

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