Comparison of the Efficacy of the Embolic Agents Acrylamido Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Artery Embolization for Leiomyomas: A Prospective Randomized Controlled Trial

Journal Article · Wed Jun 15 00:00:00 EDT 2011 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-010-0049-Y· OSTI ID:21608697

Siskin, Gary P; Hegener, Paul ^[1]; Chesnick, Richard ^[2]

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1. Albany Medical College, Department of Radiology (United States)
2. Professional Diagnostic Imaging (United States)

Objective: To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres (a-PVAM) as an embolic agent for uterine artery embolization (UAE) compared with Tris-acryl gelatin microspheres (TAGM).Design, Setting, ParticipantsProspective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas.InterventionUAE procedure was performed with either of the two embolic agents. Either 700-900-{mu}m a-PVAM or 500-700-{mu}m TAGM was used.Main Outcome MeasuresChanges in leiomyoma perfusion, overall uterine volume, and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week, 3 months, and 6 months after UAE by a reader blinded to the embolic agent used. Changes in Uterine Fibroid Symptoms and Quality of Life questionnaire scores were measured at 3, 6, and 12 months after UAE. Results: Forty-six patients were randomized and treated under the study protocol (a-PVAM n = 22, TAGM n = 24). There were no procedure-related complications. Two patients were excluded from analysis (one technical failure of the procedure, one withdrawal from study). Successful (>90%) leiomyoma devascularization was observed in 81% of subjects at 1 week after UAE, 97% at 3 months after UAE, and 95% at 6 months after UAE. No significant differences were observed in 14 of 15 outcome measurements, consistent with noninferiority. TAGM was slightly superior to a-PVAM on one comparison (overall quality of life at 3 months after UAE).

• OSTI ID: 21608697
• Journal Information: Cardiovascular and Interventional Radiology, Vol. 34, Issue 3; Conference: CIRSE 2011: Annual meeting of the Cardiovascular and Interventional Radiological Society of Europe, Munich (Germany), 10-14 Sep 2011; Other Information: DOI: 10.1007/s00270-010-0049-y; Copyright (c) 2011 Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
• Country of Publication: United States
• Language: English

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