Comparison of polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine fibroid embolization: results of a single-center randomized study.
OBJECTIVE
To assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas.


METHODS
A randomized, prospective, single-center study enrolled 60 women with symptomatic uterine leiomyomas. Uterine artery embolization (UAE) with spherical polyvinyl alcohol (SPVA) microspheres (n = 30; 700-900 μm and 900-1,200 μm; near-stasis or stasis endpoint) and tris-acryl gelatin (TAG) microspheres (n = 30; 500-700 μm; "pruned-tree" endpoint) was performed. Infarction rates were calculated for the dominant tumor and for small (< 2 cm) and large (> 2 cm) nondominant tumors. The primary endpoint was tumor infarction at 24 hours measured by contrast-enhanced magnetic resonance imaging assessed by a blinded reviewer.


RESULTS
Baseline characteristics were similar between groups. The primary endpoint was similar in both treatments (≥ 91% dominant tumor infarction; SPVA. 86.2%; TAG, 93.3%, P = .35). Complete infarction (100%) was also similar between arms at 24 hours and 3 months. Symptom severity was reduced and quality of life improved equally at 3 and 12 months in each treatment group. Complications were minor in both groups.


CONCLUSIONS
Uterine leiomyoma infarction at 24 hours and 3 months after treatment with SPVA or TAG microspheres was comparable when using near-stasis as a procedural endpoint with SPVA microspheres. Symptom relief was maintained for as long as 12 months for both embolic agents.
Department of Radiology, Division of Interventional Radiology, Hospital of the University of Pennsylvania and The Perelman School of Medicine at the University of Pennsylvania, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104. Electronic address: shlanskr@uphs.upenn.edu.
Richard D
RD
Shlansky-Goldberg
Department of Radiology, Division of Interventional Radiology, Hospital of the University of Pennsylvania and The Perelman School of Medicine at the University of Pennsylvania, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.
Mark A
MA
Rosen
Department of Radiology, Division of Interventional Radiology, Hospital of the University of Pennsylvania and The Perelman School of Medicine at the University of Pennsylvania, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.
Jeffrey I
JI
Mondschein
Department of Radiology, Division of Interventional Radiology, Hospital of the University of Pennsylvania and The Perelman School of Medicine at the University of Pennsylvania, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.
S William
SW
Stavropoulos
Department of Radiology, Division of Interventional Radiology, Hospital of the University of Pennsylvania and The Perelman School of Medicine at the University of Pennsylvania, 3400 Spruce St., 1 Silverstein, Philadelphia, PA 19104.
Scott O
SO
Trerotola
Boston Scientific, Natick, Massachusetts.
Juan
J
Diaz-Cartelle
D000180:Acrylic Resins / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D003287:Contrast Media; D005260:Female; D005780:Gelatin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007238:Infarction / Q000473:pathology; D007889:Leiomyoma / Q000098:blood supply / Q000175:diagnosis / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D008863:Microspheres; D008875:Middle Aged; D015143:Philadelphia; D011142:Polyvinyl Alcohol / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055357:Uterine Artery Embolization / Q000009:adverse effects / Q000379:methods*; D014594:Uterine Neoplasms / Q000098:blood supply / Q000175:diagnosis / Q000628:therapy*
D000180:Acrylic Resins; D003287:Contrast Media; C496735:trisacryl gelatin microspheres; D005780:Gelatin; D011142:Polyvinyl Alcohol