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.
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).


METHODS
Prospective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas.


METHODS
UAE procedure was performed with either of the two embolic agents. Either 700-900-μm a-PVAM or 500-700-μm TAGM was used.


METHODS
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.


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).
Image Guided Surgery Associates, PC, c/o Peripheral Vascular Institute of Philadelphia, 4220 Market Street, 2nd Floor, Philadelphia, PA 19104, USA. rkirsch@vascularcenters.com
Robert L
RL
Worthington-Kirsch
Gary P
GP
Siskin
Paul
P
Hegener
Richard
R
Chesnick
D000178:Acrylamides / Q000627:therapeutic use*; D000180:Acrylic Resins / Q000627:therapeutic use*; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005780:Gelatin / Q000627:therapeutic use*; D006801:Humans; D007889:Leiomyoma / Q000098:blood supply / Q000628:therapy*; D008875:Middle Aged; D011142:Polyvinyl Alcohol / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055357:Uterine Artery Embolization / Q000379:methods*; D014594:Uterine Neoplasms / Q000098:blood supply / Q000628:therapy*; D014599:Uterus / Q000098:blood supply / Q000473:pathology
D000178:Acrylamides; D000180:Acrylic Resins; C496735:trisacryl gelatin microspheres; D005780:Gelatin; D011142:Polyvinyl Alcohol