A multi-centre retrospective cohort study comparing the efficacy, safety and cost-effectiveness of hysterectomy and uterine artery embolisation for the treatment of symptomatic uterine fibroids. The HOPEFUL study.

OBJECTIVES: To examine and compare the medium-term results of hysterectomy and uterine artery embolisation (UAE) as a treatment for symptomatic uterine fibroids with regard to safety, efficacy, special issues in the UAE group, cost-effectiveness, and women's own perspectives on the treatments. DESIGN: Data were collected locally from patients' hospital records and also from patients themselves by postal questionnaire. Questionnaire data included free-text comments and this qualitative material was analysed using constant comparison. A two-stage probabilistic decision model was designed to estimate UK NHS costs and health outcomes in terms of quality-adjusted life-years (QALYs). SETTING: Eighteen NHS hospital trusts, 17 in England and one in Scotland. PARTICIPANTS: Eligible women (972 UAE, 762 hysterectomies) who had received treatment specifically for symptomatic fibroids were identified. INTERVENTIONS: The UAE patients were treated by experienced interventional radiologists and all received their index UAE prior to the end of 2002, ensuring a minimum 2-year follow-up. The average length of follow-up was 8.6 years for the hysterectomy cohort and 4.6 years for the UAE cohort. MAIN OUTCOME MEASURES: Primary outcome measures were complication rates to assess the comparative safety of the two interventions. Secondary outcome measures related to treatment efficacy including resolution of symptoms and patient-reported satisfaction with treatment. Further efficacy outcome measures obtained in the UAE group included fibroid/uterine size shrinkage and further treatments required for unresolved fibroid symptoms. Data were also gathered on pregnancies post-UAE. RESULTS: Data were available for 1108 women (649 UAE and 459 hysterectomy). Fewer complications were experienced by women in the UAE cohort compared to the hysterectomy cohort: hysterectomy n = 120 (26.1%), UAE n = 114 (17.6%), adjusted odds ratio 0.48 [95% confidence interval (CI) 0.26 to 0.89]. When only the severe/major complications were considered, this odds ratio was reduced to 0.25 (95% CI 0.13 to 0.48). Expected general side-effects of UAE occurred in 32.7% of the UAE cohort, of which 8.9% also experienced complications. Obesity and medical co-morbidity predisposed women to complications, whereas prophylactic antibiotics appeared to protect against both complications and the expected side-effects of UAE. More women in the hysterectomy cohort reported relief from fibroid symptoms (89% versus 80% UAE, p less than 0.0001) and feeling better (81% versus 74% UAE, p less than 0.0001), but only 70% (compared with 86% UAE, p = 0.007) would recommend their treatment to a friend. In the UAE cohort, 18.3% of the women went on to receive one or more further fibroid treatments including hysterectomy (11.2%). After adjusting for differential time of follow-up, the UAE women had up to a 23% (95% CI 19 to 27%) likelihood of requiring further treatment. The free-text data indicated that many women, in both cohorts, felt that their treatment had been a complete success. In the UAE cohort there were several areas where expectations were apparently high and outcome had not fulfilled their expectations. Disappointment was expressed mainly about continuation or return of symptoms or failure to become pregnant. Many continued to have remaining questions about their treatment. The economic analysis indicated that UAE is less expensive than hysterectomy even after further treatments for unresolved or recurrent symptoms are taken into account, with little difference in QALYs between the two treatments. Younger women are exposed to the risk of recurrent fibroids and subsequent additional procedures over a longer period and consequently UAE may no longer be cost-effective. CONCLUSIONS: The study results suggest that both UAE and hysterectomy are safe. No unexpected problems were detected following UAE after a long follow-up period (average 5 years). Complications are less common for UAE than hysterectomy. The cost-effectiveness analysis favours embolisation even after taking account of complications, expected side-effects associated with the procedure and subsequent re-treatments for women with a preference for uterus preservation. It is important to improve the management of expectations following UAE, particularly regarding fertility. The data suggested that fertility and miscarriage rate are consistent with those of age-matched women with fibroids. UAE is an effective treatment for some women with fibroids and our trial supports the National Institute for Health and Clinical Excellence guidance that it should be made available as one of the options for treatment, with a possible reduction in the need for hysterectomy as the first-line treatment. Further research is needed into which women will be treated most successfully by UAE, the best method of achieving effective embolisation, advice for women who desire future fertility, the role of prophylactic antibiotics in UAE, and the effects of HRT use after UAE on recurrence of fibroid symptoms.