Randomized EMMY trial concludes that long-term efficacy of UAE still needs to be proven

Two randomized controlled trials started in early 2001 to compare uterine artery embolization (UAE) with standard surgical procedures such as hysterectomy and myomectomy have presented their preliminary results. Wouter Hehenkamp presented the results of the Dutch EMbolisation versus hysterectoMY (EMMY) trial at the CIRSE annual meeting in Nice. The study was focused on treatment-related pain and the resumption of daily activities. Dr Jon Moss, Gartnavel General Hospital, Glasgow, UK, presented the latest results from the Scottish Randomised Study of Embolization and Surgical Treatment for Uterine Fibroids (REST) at the annual meeting of the British Society of Interventional Radiology. The results will be published in the Lancet later this year.

Despite uterine artery embolisation (UAE) patients returning to daily activities sooner than those receiving a hysterectomy, the preliminary results of the EMMY trial, a randomized comparison of UAE and hysterectomy in the treatment of symptomatic uterine fibroids, have concluded that long-term efficacy of UAE versus hysterectomy still needs to be determined.

Dr Wouter Hehenkamp from the Gynaecology department of Amsterdam's Academic Medical Center, The Netherlands, who has collaborated with Professor Jim Reekers, presented the pain and recovery results of the EMMY trial. The EMMY investigators concluded that as far as pain is concerned, neither UAE nor hysterectomy seemed to be clearly superior. Recovery from UAE was significantly faster than from hysterectomy and resumption of daily activity was always in favour of UAE.

Compared with a hysterectomy, UAE leaves the uterus intact and allows the feed supply to all fibroids to be obstructed, regardless of the amount or where they are located, thereby limiting the risk of recurrence. Clinical studies carried out on a large number of women comparing the two procedures show that UAE offers a better therapeutic option (no general anaesthetic, no risk of haemorrhage, no surgical incision, shorter hospital stay, speedy recovery period) and at a lower cost than that of a hysterectomy.

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.

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 versus 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 (see Table 1), 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 (see Table 2).

Hehenkamp concluded that UAE patients experienced significantly more pain during the first 24 hours after treatment and UAE patients showed less pain improvement than hysterectomy patients. In comparison, the resumption of daily activities was always in favour of UAE.

Overall, Hehenkamp said that neither treatment was clearly superior and that the long-term efficacy of UAE versus hysterectomy still needed to be determined. This data will be made available by the end of 2005, the investigators said.