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
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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, Participants
Prospective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas.
UAE procedure was performed with either of the two embolic agents. Either 700–900-μm a-PVAM or 500–700-μm TAGM was used.
Main Outcome Measures
Changes 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.
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).
KeywordsClinical practice Embolization Uterine artery embolization Uterine fibroid embolization Urogenital Uterine fibroid
Unrestricted research grants from Terumo Interventional Systems USA (Somerset, NJ) and Biocompatibles UK (Farnham, Surrey, UK). Registered as NCT00361036 with ClinicalTrials.gov.
Conflict of interest
Drs. Hegener and Chesnick have no conflicts. Dr. Worthington-Kirsch has received an unrestricted educational grant from Terumo Interventional Systems USA and Biocompatibles for this study (no grant number, grant awarded in 2005). In the past (>3 years ago), Dr. Worthington-Kirsch received research support from Biosphere Medical and from Boston Scientific. Within the last year, Dr. Worthington-Kirsch has received honoraria for speaking to the U.S. sales forces of both Biocompatibles and Merit/Biosphere Medical. Dr. Siskin is a consultant to CeloNova and Boston Scientific.
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