Richard D Shlansky-Goldberg1, Mark A Rosen2, Jeffrey I Mondschein2, S William Stavropoulos2, Scott O Trerotola2, Juan Diaz-Cartelle3. 1. 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. 2. 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. 3. Boston Scientific, Natick, Massachusetts.
Abstract
PURPOSE: To assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas. MATERIALS AND 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.
RCT Entities:
PURPOSE: To assess the efficacy of two embolic agents in the treatment of symptomatic uterine leiomyomas. MATERIALS AND 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.
Authors: L A Torres-de la Roche; C Cezar; S Hanif; R Devassy; H Krentel; J Hennefründ; R L De Wilde Journal: Biomed Res Int Date: 2022-02-15 Impact factor: 3.411