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Uterine Fibroids: Uterine Artery Embolization versus Abdominal Hysterectomy for Treatment—A Prospective, Randomized, and Controlled Clinical Trial¹

¹ From the Departments of Radiology (I.P., P.C., L.P.) and Gynecology and Obstetrics (A.R., J.H., J.B.), and the Intensive Care Unit (M.A.d.l.C.), University Hospital of Getafe, Carretera de Toledo, Km 12,500, 28905 Getafe-Madrid, Spain. Received October 19, 2001; revision requested December 3; final revision received May 7, 2002; accepted June 5. Supported by grants from FIS (Fondo de Investigación Sanitaria, Instituto de Salud Carlos III, Spain) and Cook-Spain. Address correspondence to I.P. (e-mail: pintopabon@mi.madritel.es).

PURPOSE: To evaluate the effectiveness of uterine artery embolization (UAE) in the management of bleeding in patients with uterine fibroids and to compare UAE with hysterectomy, particularly with regard to length of hospital stay and associated complications (ie, safety).

MATERIALS AND METHODS: A prospective clinical trial was performed with patients who were randomly assigned to one of two groups: patients who were offered the option of undergoing either UAE or hysterectomy (group 1) and patients who were not informed of the alternative treatment—that is, UAE (group 2). The primary variables that were considered for evaluation of the effectiveness, efficiency, and safety of the two procedures were, respectively, bleeding cessation, total length of hospital stay, and resulting complications. The lengths of hospital stay in the two study arms were compared on an intent-to-treat basis. Owing to crossover between the treatment arms, however, effectiveness and safety were evaluated on the basis of the actual treatment received.

RESULTS: The clinical success rate for the patients who underwent UAE, which was based on the cessation of bleeding, was 86% (31 of 36 patients). The mean hospital stay for group 1 was 4.14 days shorter than that for group 2 (P < .001). Ten (25%) of the 40 patients who underwent UAE experienced minor complications, in contrast to four (20%) of the 20 who underwent hysterectomy and experienced major complications.

CONCLUSION: Compared with hysterectomy, UAE is safe and effective for treatment of bleeding fibroids, necessitates a shorter hospital stay, and results in fewer major complications.

© RSNA, 2002

Index terms: Arteries, therapeutic embolization, 854.1264, 854.1266, 986.1264, 986.1266 • Leiomyoma, 854.318, 986.7151 • Uterine neoplasms, 854.318, 986.7151 • Uterine neoplasms, therapy, 854.1264, 854.1266, 986.1264, 986.1266

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