Clinical study
Comparison of Clinical Outcomes of Tris-acryl Microspheres Versus Polyvinyl Alcohol Microspheres for Uterine Artery Embolization for Leiomyomas: Results of a Randomized Trial

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Abstract

Purpose

To compare tris-acryl microspheres and polyvinyl alcohol (PVA) microspheres as embolic agents in uterine artery embolization (UAE) for uterine leiomyomas in terms of clinical outcome, inflammatory response, and adverse reactions.

Materials and Methods

A double-blinded randomized controlled trial was performed, with 27 patients in the tris-acryl microsphere group and 29 in the PVA microsphere group. The primary endpoint was clinical success, defined as a 2-year freedom from subsequent surgery as a result of persistent or deteriorated symptoms. Secondary endpoints included (i) posttreatment leiomyoma enlargement, (ii) leiomyoma volume reduction at 3 and 9 months, (iii) significant residual intratumoral perfusion, (iv) increase in inflammatory and stress markers, (v) incidence of complications, and (vi) duration of hospital stay.

Results

There was no statistically significant difference between the two groups in patient demographics, clinical presentation, initial tumor findings, change in inflammatory and stress markers after treatment, incidence of complications, and duration of hospital stay. Tris-acryl microspheres were associated with a higher rate of clinical success than PVA microspheres (96.3% [26 of 27] vs 69% [20 of 29]; P = .012), a lower incidence of posttreatment leiomyoma enlargement (P = .030), and a lower incidence of significant residual intratumoral perfusion (P = .030).

Conclusions

In the treatment of uterine leiomyomas, UAE with tris-acryl microspheres was associated with a higher clinical success rate, a lower incidence of tumor enlargement, and no significant differences in adverse reactions and inflammatory response compared with the use of PVA microspheres. Tris-acryl microspheres therefore represent the preferred agent for UAE of uterine leiomyomas.

Section snippets

Study Design

A prospective, double-blinded, randomized controlled trial was conducted in accordance with the Declaration of Helsinki, with approval obtained from the institutional review board. A signed informed consent form was obtained from each patient. Sixty patients were randomly assigned at a 1:1 ratio to the treatment groups to receive tris-acryl microspheres (500–700-μm Embosphere particles; BioSphere, Roissy, France) or PVA microspheres (500–700-μm Contour SE particles; Boston Scientific, Natick,

Patient Demographics and Clinical Findings

During the period from February 2006 to November 2009, 457 patients with uterine leiomyomas were managed in the authors' institution. A total of 290 underwent surgery, 61 did not meet study inclusion criteria, and 46 chose not to participate. Sixty patients were recruited into the study, with 30 patients randomly allocated into each of the two groups to receive the allocated intervention. After the embolization procedure, one patient in the PVA microsphere group and three patients in the

Discussion

The aim of uterine leiomyoma embolization is infarction of tumors (7). Pathologic studies of leiomyomas successfully embolized and devascularized tumors typically show hyaline necrosis or coagulative necrosis of the tumor (8, 9). However, failure of complete devascularization of tumors may affect long-term clinical outcome and lead to persistent or recurrent symptoms (10, 11). MR imaging can be used to assess the degree of posttreatment residual intratumoral arterial perfusion, which may

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None of the authors have identified a conflict of interest.

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