At a special session at this year's CIRSE meeting in Rome, Italy, interventional radiologists gathered to hear the results from two studies that compared hysterectomy and uterine artery embolisation (UAE or uterine fibroid embolisation [UFE]). Although UAE is widely practiced in the US and in some European countries (UK and France) many women throughout Europe still do not have access to this procedure, only a limited number of gynaecologists have referred their patients to receive embolisation treatment.
REST
Dr Jon Moss, Glasgow, UK, presented one-year results from the Randomised Study of Embolisation and Surgical Treatment for Uterine Fibroids (REST). This multi-centre randomised controlled trial involving all but two Scottish Health Boards plus two English centres. REST was established following recommendations by both the Royal College of Radiologists (RCR) and the Royal College of Obstetricians and Gynaecologists that UAE be offered to women with uterine fibroids as an alternative to surgery. In REST, a total of 157 patients were randomised using a 2:1 allocation to receive either UAE (n=106) or surgery (n=51), respectively, from November 2000 to March 2004. The primary outcome measure was Quality of life measured at 12 months; secondary outcomes included morbidity, pain scores, and time to achieve various lifestyle events, hospital stay and re-intervention rates. Ninety five percent of patients underwent their allocated treatment; UAE (n=101), hysterectomy (n=40) and myomectomy (n=8).
The results revealed that there was no statistical significant difference in quality of life at one-year. The length of hospital stay was significantly shorter in those having UAE compared with surgery, although the time to performing routine tasks was significantly shorter in the UAE group. Symptom scores were significantly better in the surgical arm at all time points. A total of ten (9%) of patients in the UAE arm required further invasive treatment for symptom control. At one-year women randomised to UAE had a 4% probability of having a repeat UAE and a 6% chance of a hysterectomy. There were 33 (31%) serious adverse events (SAE`s) in the UAE arm and nine (18%) in the surgical arm at latest follow-up (maximum 56 months). Economic analysis showed a significant difference in cost (UAE £1,757 vs. £2,702 surgery).
According to Moss, both UAE and surgery provide a successful outcome for a majority of women with symptomatic fibroids, as the results showed there was no difference in the primary outcome measure (QoL) at one-year. Short term follow up of those having UAE showed a significantly more rapid recovery period, although these patients had a significantly poorer symptom control compared to surgery. The complications after surgery usually occurred in the early post-operative period whereas some of those occurring after UAE did so after a prolonged period of time, therefore those receiving UAE require a longer-term follow-up (beyond one-year) particularly since a number of major complications occurred many months after treatment. The study was sufficiently powered to show the effect of UAE on fertility or pregnancy.
On the basis on the one-year results, Moss said that UAE should be considered for patients as an alternative to surgery for symptomatic fibroids. The advantage of faster recovery following UAE must be weighed against the need for further treatment in a minority of patients, long-term complications and an unknown effect on pregnancy. "Data from this study will provide the gynaecologist, radiologist, primary health care practionioner and patient with more information to help decide the appropriate treatment for individual patients with fibroids," he added.
Although welcoming the results, Moss cautioned that more research is needed on the long-term outcome of UAE in regard to recurrence of both fibroids and symptoms requiring further treatment. In addition, a further randomised control trial of UAE and myomectomy would examine issues of fertility appropriately since only observational data currently available.
EMMY
Two-year results from the Dutch EMbolisation versus hysterectoMY (EMMY) trial supported the results from REST study. The purpose of the EMMY trial was to evaluate the safety and efficacy of UAE and hysterectomy for symptomatic uterine fibroids.
A total of 177 patients were included in the trial (89 hysterectomies; 88 UAEs), in 28 centres in The Netherlands. Pain scores (numerical rating scale) and other aspects of pain were measured, and recovery to the various activities was assessed by a questionnaire. Patients' criteria included: Uterine fibroids, heavy menstrual bleeding (classical indications for hysterectomy) and no wish to conceive. The primary endpoint of the study was the elimination of heavy bleeding, with the cessation of pain and a return to normal activities as secondary endpoints. Of the 89 patients recruited to the hysterectomy arm 76 had a hysterectomy performed and 81 (from 88) underwent a UAE procedure.
As previously reported by Interventional News, the results revealed that after 24-hours UAE patients experienced significantly more pain after treatment as determined by the univariate mixed models regression analysis (70.4 v. 67.3% p=0.012). Fifty percent of UAE patients reported freedom from pain after seven days, compared to 10-days for hysterectomy patients. Six weeks after discharge, 9.9% of UAE patients still experienced pain, compared with 16% of hysterectomy patients (non-statistically significant difference, p=0.25. After the same the period, 12.3% of UAE patients were still receiving medication, compared with 18.7% of hysterectomy patients. However, the recovery from UAE was significantly faster than from hysterectomy.
Professor Jim Reekers, Amsterdam, the Netherlands, and principle investigator of the EMMY trial said that results show that the non-inferiority of UAE vs. surgery has been proven (study definition: to avoid hysterectomy in 25% of patients [which were planned for hysterectomy] at two years).
At two years, the EMMY trial showed a similar quality of life for both groups and that embolisation is also cheaper than the surgical option. In hospital costs after embolisation, intention to treat, are 19% lower at two years compared to hysterectomy. The overall costs revealed that UAE was 37% lower than the surgical option.
As a result, Reekers concluded: "UAE should be the first choice treatment option in patients for symptomatic fibroids who want to avoid hysterectomy."
Published: Nov 2006
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