Comparison of Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Fibroid Embolization: Results of a Single-Center Randomized Study |
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Affiliation: | 1. College of Pharmacy, Xi''an Medical University, Xi''an 710021, PR China;2. College of Medical Technology, Xi''an Medical University, Xi''an 710021, PR China |
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Abstract: | PurposeTo assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas.Materials and MethodsA 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.ResultsBaseline 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.ConclusionsUterine 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. |
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Keywords: | FDA" },{" #name" :" keyword" ," $" :{" id" :" key0010" }," $$" :[{" #name" :" text" ," _" :" Food and Drug Administration SPVA" },{" #name" :" keyword" ," $" :{" id" :" key0020" }," $$" :[{" #name" :" text" ," _" :" spherical polyvinyl alcohol TAG" },{" #name" :" keyword" ," $" :{" id" :" key0030" }," $$" :[{" #name" :" text" ," _" :" tris-acryl gelatin UAE" },{" #name" :" keyword" ," $" :{" id" :" key0040" }," $$" :[{" #name" :" text" ," _" :" uterine artery embolization UFS-QoL" },{" #name" :" keyword" ," $" :{" id" :" key0050" }," $$" :[{" #name" :" text" ," _" :" Uterine Fibroid–Specific Quality of Life |
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