Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results

BJOG. 2011 Jul;118(8):936-44. doi: 10.1111/j.1471-0528.2011.02952.x. Epub 2011 Apr 12.

Abstract

Objective: To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids.

Design: Pragmatic, open, multicentre, randomised trial.

Setting: Twenty-seven participating UK secondary care centres.

Sample: Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment.

Methods: In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine).

Main outcome measures: Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention.

Results: There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years.

Conclusions: We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Cost-Benefit Analysis
  • Female
  • Humans
  • Hysterectomy* / adverse effects
  • Hysterectomy* / economics
  • Leiomyoma / economics
  • Leiomyoma / surgery
  • Leiomyoma / therapy*
  • Middle Aged
  • Quality of Life
  • Treatment Outcome
  • United Kingdom
  • Uterine Artery Embolization* / adverse effects
  • Uterine Artery Embolization* / economics
  • Uterine Neoplasms / economics
  • Uterine Neoplasms / surgery
  • Uterine Neoplasms / therapy*