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
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Robert L. Worthington-Kirsch Gary P. Siskin Paul Hegener Richard Chesnick
- چاپ و سال / کشور: 2010
Description
Objective To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres (a-PVAM) as an embolic agent for uterine artery embolization (UAE) compared with Trisacryl 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. Intervention UAE procedure was performed with either of the two embolic agents. Either 700–900-lm a-PVAM or 500–700-lm 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. 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).
Cardiovasc Intervent Radiol (2011) 34:493–501 DOI 10.1007/s00270-010-0049-y Received: 23 April 2010 / Accepted: 4 November 2010 / Published online: 3 December 2010
