Clinical Study
Comparison of Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Fibroid Embolization: Results of a Single-Center Randomized Study

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Abstract

Purpose

To assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas.

Materials and Methods

A randomized, prospective, single-center study enrolled 60 women with symptomatic uterine leiomyomas. Uterine artery embolization (UAE) with spherical polyvinyl alcohol (SPVA) microspheres (n = 30; 700–900 μm and 900–1,200 μm; near-stasis or stasis endpoint) and tris-acryl gelatin (TAG) microspheres (n = 30; 500–700 μm; “pruned-tree” endpoint) was performed. Infarction rates were calculated for the dominant tumor and for small (< 2 cm) and large (> 2 cm) nondominant tumors. The primary endpoint was tumor infarction at 24 hours measured by contrast-enhanced magnetic resonance imaging assessed by a blinded reviewer.

Results

Baseline characteristics were similar between groups. The primary endpoint was similar in both treatments (≥ 91% dominant tumor infarction; SPVA. 86.2%; TAG, 93.3%, P = .35). Complete infarction (100%) was also similar between arms at 24 hours and 3 months. Symptom severity was reduced and quality of life improved equally at 3 and 12 months in each treatment group. Complications were minor in both groups.

Conclusions

Uterine leiomyoma infarction at 24 hours and 3 months after treatment with SPVA or TAG microspheres was comparable when using near-stasis as a procedural endpoint with SPVA microspheres. Symptom relief was maintained for as long as 12 months for both embolic agents.

Section snippets

Materials and Methods

This was a prospective, randomized, single-center, single-blind, parallel-group, noninferiority study registered on the National Institutes of Health Web site (www.clinicaltrials.gov) under identifier NCT00628901. The study was funded by Boston Scientific (Natick, Massachusetts). Institutional review board approval was obtained, and the protocol and consent forms were consistent with US FDA Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance, the Declaration of Helsinki, the

Results

Three hundred twenty-two patients were screened for inclusion criteria, and 60 patients were randomized after excluding 56 patients (Fig 1). The baseline clinical characteristics of the randomized groups were well balanced, with no significant differences (Table 1). In both arms, the majority of the women were black, with an average age of slightly older than 40 years. Baseline uterine and tumor volume, number of tumors, and quality-of-life scores were also similar (Figs 2 and 3, Table 1).

Discussion

UAE is a safe, minimally invasive, and uterus-sparing alternative to surgery for the relief of leiomyoma-related symptoms. Conflicting results regarding the most effective type of embolic particle have recently arisen (11, 15). The present study, which examined patients treated with SPVA or TAG microspheres, found no significant differences between groups in dominant tumor infarction rates after 24 hours or 3 months. The majority of patients had complete infarction, which has previously been

Acknowledgments

The study was conceived by R.D.S.-G. with input from Boston Scientific. The authors thank Kristine Roy, PhD, (Boston Scientific) for assistance in manuscript preparation, Lan Pan (Boston Scientific) for statistical analysis, and Colleen Holthe (Boston Scientific) for her efforts in project management. The first and final drafts of the manuscript were written by R.D.S.-G. with contributions to the Materials and Methods and Results sections from Kristine Roy.

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    From the SIR 2011 Annual Meeting.

    R.D.S.-G. is a paid consultant for Grisfols (Research Triangle Park, North Carolina) and Boston Scientific (Natick, Massachusetts) and received grant support from Boston Scientific and CeloNova BioSciences (San Antonio, Texas). S.O.T. received royalties from Arrow/Teleflex (Research Triangle Park, North Carolina) and Cook (Bloomington, Indiana); is a paid consultant for Arrow/Teleflex, Cook, B. Braun (Melsungen, Germany), W.L. Gore and Associates (Flagstaff, Arizona), and Bard (Summit, New Jersey); and received grant support from Vascular Pathways (Naples, Florida). S.W.S. received grant support from Bard, W.L. Gore and Associates, and Merit Medical (South Jordan, Utah); and is a paid consultant for Bard and Cook. J.D.-C. is a full-time employee and stock options holder of Boston Scientific. None of the other authors have identified a conflict of interest.

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