Clinical StudyComparison of Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Fibroid Embolization: Results of a Single-Center Randomized Study
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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2021, Journal of Vascular and Interventional RadiologyCitation Excerpt :Another reason was that some patients prefer not to undergo UAE during the menstrual phase; therefore, the results from the menstrual phase were considered to be clinically important. The imaging and clinical outcomes in this study were similar to those previously reported (5,16–18). In the present study, contrast-enhanced MR imaging 1 week after UAE was used to evaluate leiomyoma infarction.
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2020, Journal of Vascular and Interventional RadiologyCitation Excerpt :The angiographic endpoints for PAE have not been defined in an objective manner; this remains a question to be answered by future study. Further, agent-specific embolization endpoints may emerge, as observed in the uterine artery embolization (UAE) literature (87). Terms such as “near-stasis” and “total stasis” have been used (72,77).
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.