The EMMY trial of uterine artery embolization for the treatment of symptomatic uterine fibroid tumors: randomized, yes, but a flawed trial nonetheless.

IN this issue of JVIR, an analysis of the short-term results of the EMMY Trial (EMbolization versus hysterectoMY) is published, focusing on the technical outcome of the procedure (1). This article is one of an anticipated series of reports of a randomized trial from The Netherlands comparing the outcomes from uterine artery embolization (UAE) versus those of hysterectomy. The first of the publications from this trial appeared in November 2005 in the American Journal of Obstetrics and Gynecology and focused on the recovery and short-term outcome from the procedure (2). As certain aspects of the study design are described better in the earlier publication, this commentary will review the results from both these publications. The study is a randomized trial to compare outcomes from the two procedures, with 177 patients enrolled (88 treated with UAE and 89 treated with hysterectomy). The primary endpoint of the study was the elimination of menorrhagia after a follow-up period of 2 years, with UAE considered equivalent to hysterectomy if menorrhagia resolved in at least 75% of patients with no significant differences in major complications between the two procedures. A power analysis yielded a requirement of 120 total patients to be included. Although that calculation was based on the 2-year outcome, the two initial reports focus on a number of short-term measures for which no separate power analysis was completed. The report in the American Journal of Obstetrics and Gynecology reported the following key findings (2): The technical failure rate for the procedure was significantly higher with UAE, bilateral UAE failed in 4.9% of patients, and an additional 6.2% patients had a unilateral technical failure. Major complications occurred in 4.9% of patients in the UAE group and 2.7% in the hysterectomy group, incidences that were not significantly different (P .68). They did find that UAE was significantly more likely to result in minor complications (58% vs 40%; relative risk, 1.45; P .024). The difference in minor complications occurred in the follow-up phase of the study during the first 6 weeks after discharge, with adverse events much more likely in the UAE group. Although the total length of stay was shorter for patients who were treated with UAE (mean, 2.5 days vs 5.1 days; P .001), patients in the UAE group were readmitted more often (11.1% vs 0; P .003), with most readmissions within the first several days after discharge. Additional analysis is provided in the publication in this issue of JVIR (1). In this article, the authors report a technical failure rate of 5.3% and a procedural failure rate of 17.3%. In this set of definitions, a technical failure is one in which bilateral uterine tumor arterial supply is not occluded. A procedural failure is a procedure in which bilateral embolization was not completed for any reason and includes those with an absent uterine artery (with ovarian artery replacement not treated), those with no uterine artery flow after catheterization, and those with extensive collateral vessels to the vagina or cervix, in addition to the technical failures. The frequency of incomplete embolization in this group of patients raises concerns about the clinical outcomes that will be noted 2 years after therapy when the trial is concluded. Based on these two articles, authors have reached the following initial conclusions: there is a higher than previously reported technical failure rate for UAE, postdischarge complications are more likely for patients treated with UAE, and there is a higher readmission rate among patients treated with UAE. In the article in this journal From the Department of Radiology, CG 201, Georgetown University Hospital, 3800 Reservoir Road Northwest, Washington, DC 20007-2113. Received December 28, 2005; accepted December 31. Address correspondence to J.B.S.; E-mail: spiesj@gunet. georgetown.edu.