Randomised controlled trial of Particles used in Uterine fibRoid Embolisation (PURE)-non-spherical polyvinyl alcohol (Contour PVA; Boston Scientific, USA) versus calibrated hydrogel microspheres with polyzene coating (Embozene; CeloNova Biosciences USA): Interim results

Purpose: The PURE study is a randomised controlled trial designed to evaluate clinical, MRI and technical outcomes between two embolic agents in uterine artery embolisation (UAE): non-spherical polyvinyl alcohol (ns-PVA) and calibrated hydrogel microspheres (Embozenes). Material and Methods: Prospective, ethically approved non-sponsored randomised controlled trial in a UK tertiary IR unit. The study is designed to recruit 80 patients with a 6-month follow-up. UAE was performed via bilateral arterial access and following a standardised embolisation protocol and a single-blinded design. Primary outcome: Assessment of symptomatic improvement using the validated Uterine Fibroid Symptom and Health-related Quality of Life questionnaire (UFS-HRQOL). Secondary outcomes: Using contrast-enhanced MRI performed before and at 6 months after UAE 1. Percentage fibroid infarction of total fibroid burden and dominant fibroid. 2. Uterine and dominant fibroid volume reductions. 3. Uterine artery recanalisation and presence of ovarian collaterals. 4. Volume of embolic agent required, fluoroscopy time and radiation dose. Results: Forty patients have currently enrolled in the study and the full 6-month follow-up with interim comparative statistical analysis will be complete for CIRSE congress in September 2014. Analysis of volumes of embolic agent has demonstrated a statistically significant difference with a mean volume of 5.5 syringes (range, 1-12) of Embozenes used versus 3.8 vials of ns-PVA (range, 2-8) (p=0.05). No significant difference was detected with respect to fluoroscopy time or radiation dose. Conclusion: The study involves comprehensive clinical and MRI outcome assessment to evaluate two contemporary and widely used particulate embolic agents. The PURE study will guide IR practitioners regarding the relative efficacy of embolic agents in UAE.