Scientific evidence

Clinical studies

Studies have shown that the clinical success of UFE for symptomatic fibroids matches that of the surgical alternatives (hysterectomy and myomectomy) in terms of symptom control, complication rates and patient satisfaction. The positive outcomes of the studies below (REST and EMMY) have been confirmed by recent 5-year follow-up.

Randomised Study of Embolisation and Surgical Treatment for Uterine Fibroids (REST)

REST was an British randomised trial comparing uterine artery embolisation and surgery in women with symptomatic uterine fibroids.The primary outcome was quality of life (SF-36 questionnaires) at 1 year of follow-up. Patients were randomly assigned in a 2:1 ratio to undergo either uterine artery embolisation or surgery, with 106 patients undergoing embolisation and 51 undergoing surgery (43 hysterectomies and 8 myomectomies). There were no significant differences between groups in any of the eight components of the SF-36 scores at 1 year. The embolisation group had a shorter median duration of hospitalisation than the surgical group (1 day vs. 5 days,P<0.001) and a shorter time before returning to work (P<0.001).At 1 year, symptom scores were better in the surgical group(P=0.03). During the first year of follow-up, there were 13 major adverse events in the embolisation group (12%) and 10 in the surgical group (20%) mostly related to the intervention which, statistically, is no significant difference. Ten patients in the embolisation group (9%) required repeated embolisation or hysterectomy for inadequate symptom control. After the first year of follow-up, 14 women in the embolisation group (13%) required hospitalisation, 3 of them for major adverse events and 11 for reintervention for treatment failure.

Conclusion of the study: In women with symptomatic fibroids, the faster recovery after embolisation must be weighed against the need for further treatment in a minority of patients (January 2007).

EMbolisation versus hysterectoMY (EMMY) trial

EMMY was a randomised controlled trial to evaluate the safety of uterine artery embolisation (UAE) compared with hysterectomy. Twenty-eight Dutch hospitals recruited 177 patients with symptomatic uterine fibroids and menorrhagia who were eligible for hysterectomy. Patients were randomised to UAE (n = 88) or hysterectomy (n = 89). In this paper the peri- and postprocedural complications, length of hospital stay, unscheduled visits, and readmission rates up to 6 weeks' post-intervention were evaluated. Analysis was by intention to treat.

Bilateral UAE failure occurred in 4 patients (4.9%). Major complications occurred in 4.9% (UAE) and 2.7% (hysterectomy) of cases which statistically is no significant difference. The minor complication rate from discharge until 6 weeks after was significantly higher in the UAE group than in the hysterectomy group (58.0% vs 40.0%; RR 1.45 [1.04-2.02]; P = .024). UAE patients were more often readmitted (11.1% vs 0%; P = .003). Total length of hospital stay was significantly shorter in UAE patients (mean [SD]: 2.5 [2.7] vs 5.1 [1.3], P < .001).

Conclusion of the study: UAE is a procedure similar to hysterectomy with a low major complication rate and with a reduced length of hospital stay. Higher readmission rates after UAE stress the need for careful postprocedural follow-up (2006).