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

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 &...

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Detalles Bibliográficos
Autores principales: Das, Raj, Wale, Anita, Renani, Seyed Ameli, Ratnam, Lakshmi, Mailli, Leto, Chun, Joo-Young, Das, Sourav, Duggal, Balpreet, Manyonda, Isaac, Belli, Anna-Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Clinical Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8807446/
https://www.ncbi.nlm.nih.gov/pubmed/34984488
http://dx.doi.org/10.1007/s00270-021-02977-0
Descripción
Sumario: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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00270-021-02977-0.

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