Randomised trial of two embolic agents for uterine artery embolisation for fibroids: Gelfoam versus Embospheres (RAGE trial).

Abstract

BACKGROUND\nUterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery. However the most efficacious embolic agent remains uncertain.\n\n\nMETHODS\nWe conducted a pilot double blind randomized controlled trial comparing Gelfoam with Embospheres in women undergoing UAE. Outcomes recorded at baseline, 24-h, 1 and 6\u2009months included complications, inflammatory, haematological markers and ovarian function. Contrast enhanced MRI (CEMRI) was acquired at baseline, 24-h and 6\u2009months. Pain score (visual analogue) was measured at 24-h, quality of life (UFS-Qol) at baseline, 1 and 6\u2009months. All patients were followed to 6\u2009months.\n\n\nRESULTS\nTwenty patients were randomized 1:1 to receive either Gelfoam (G) or Embospheres (E). The UFS-Qol symptom score improved in both groups at 6\u2009months mean of 64\u2009±\u200918 to 23\u2009±\u200916 and 54\u2009±\u200915 to 32\u2009±\u200926 in the E and G groups respectively. UFS-Qol HRQL also improved in both groups at 6\u2009months, mean 41\u2009±\u200928 to 79\u2009±\u200920 and 53\u2009±\u200919 to 78\u2009±\u200921 in the E and G groups respectively. Uterine volume at 6\u2009months reduced from 1018\u2009±\u2009666mls to 622\u2009±\u2009436 (p\u2009=\u20090.001) and from 1026\u2009±\u2009756 to 908\u2009±\u2009720 (p\u2009=\u20090.15) in the E and G groups respectively. There was a significant difference between groups for this parameter p\u2009=\u20090.01. All uterine arteries were patent at 24-h and 6\u2009months. Complete (100%) fibroid infarction rates were 5(50%) and 2(20%) in the E and G groups respectively. None of the other outcome measures showed any between group differences. There were no re-interventions in either group.\n\n\nCONCLUSION\nThe only significant between group differences was for a greater reduction in uterine volume at 6\u2009months in the E group. A larger trial (estimate 172 subjects) is required to determine whether other apparent differences are clinically and statistically significant.\n\n\nTRIAL REGISTRATION\nISRCTN67347987.