Randomised Controlled Trial of Particles Used in Uterine fibRoid Embolisation (PURE): Non-Spherical Polyvinyl Alcohol Versus Calibrated Microspheres

Abstract

Purpose The PURE study is a randomised controlled trial (RCT) comparing the clinical and MRI outcomes of patients treated with non-spherical polyvinyl alcohol, ns-PVA (Contour PVA–Boston Scientific–355–500 & 500–700 microns) versus calibrated hydrogel microspheres (Embozene–Varian Inc–700 & 900 microns) for symptomatic uterine fibroids. Materials and Methods Prospective, ethically approved non-sponsored RCT in 84 patients in a single UK tertiary IR unit, ISRCTN registry trial number ISRCTN18191539 in 2013 and 2014. All patients with symptomatic fibroid disease were eligible. UAE followed a standardised protocol with UFS-QOL and contrast-enhanced MRI before and 6 months post UAE. Outcome measures included: (1) Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). (2) Percentage total and dominant fibroid infarction. (3) Uterine and dominant fibroid volume reduction. (4) Volume of embolics. Results Sixty-three patients completed the QOL follow-up (33 ns-PVA vs 30 Embozenes), the groups were equivalent at baseline. Patients were followed up for 6 months following UAE. There was no significant difference in symptom scores or HR-QOL between ns-PVA and Embozenes, p = 0.67 and 0.21, respectively. 92.7% of patients treated with ns-PVA achieved > 90% dominant fibroid infarction versus 61.8% treated with Embozenes (p = 0.0016). 66% of patients treated with ns = PVA achieved > 90% total fibroid percentage infarction compared with 35% in the Embozene group (p = 0.011). The mean vials/syringes used were 5.2 with Embozenes versus 4.1 using PVA (p = 0.08). Conclusion The PURE study informs IRs regarding the efficacy of embolic agents in UAE, with superior fibroid infarction on MRI using ns-PVA versus Embozenes however no significant difference in clinical outcomes at 6 months after UAE.

Peritoneal seeding of embolic beads after uterine artery embolization

“…A randomized controlled trial comparing non-spherical polyvinyl alcohol (ns-PVA) particles with calibrated hydrogel microspheres (Embozene) in uterine artery embolization demonstrated similar clinical outcomes at 6-month post-embolization. However, no embolic- or procedure-related complications were reported in either of the embolic groups [13] .…”

Pantoea agglomeransbacteraemia after uterine artery embolisation: an unusual pathogen

“…Treatment is based on the severity of symptoms and ranges from medical to interventional and surgical 4 5. Embolisation involves injecting small pro-embolic particles such as polyvinyl alcohol into the associated artery supplying the targeted fibroid 6. UAE has emerged as a safe and effective modality with risks ranging from fever and allergic reactions to life-threatening infections 3 4 7 8…”

Empowering Strategies for Lifestyle Interventions, Diet Modifications, and Environmental Practices for Uterine Fibroid Prevention; Unveiling the LIFE UP Awareness

“…It is advisable for women to restrict their alcohol consumption to no more than one drink per day. Excessive alcohol consumption has been linked to various health risks, and UFs are among the conditions affected by alcohol intake [ 36 , 37 ].…”