Comparison of Polyvinyl Alcohol Versus Combination of Lipiodol-Bleomycin Emulsion and NBCA-Lipiodol Emulsion for Renal Angiomyolipoma Embolization: A Prospective Randomized Study.

Abstract

<b>BACKGROUND.</b> Consensus is lacking regarding optimal embolic agents for transcatheter arterial embolization (TAE) of renal angiomyolipomas (AMLs). <b>OBJECTIVE.</b> The purpose of our study was to compare the safety and efficacy of TAE with polyvinyl alcohol (PVA) and TAE with a combination of ethiodized oil (Lipiodol)-bleomycin emulsion and <i>N</i>-butyl cyanoacrylate (NBCA)-Lipiodol emulsion for the treatment of patients with large or symptomatic AMLs. <b>METHODS.</b> This prospective study enrolled patients referred for TAE of a large (> 4 cm) or symptomatic renal AML from July 2007 to December 2018. Patients were randomized to undergo TAE using PVA particles or a combination of Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion. Patients underwent serial clinical follow-up visits and follow-up CT or MRI examinations after TAE. Outcomes were compared between groups. <b>RESULTS.</b> Seventy-eight patients were enrolled. After exclusions, the analysis included 72 patients (15 men, 57 women; mean age, 35.0 years; 51 patients with hematuria, 66 patients with flank pain): 35 patients were randomized to treatment by PVA and 37 were randomized to treatment by a combination of Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion. Complete occlusion of all angiographically visible arterial supply was achieved in all patients. No major adverse event occurred in any patient. The mean follow-up after TAE was 77 ± 45 (SD) months (range, 37-180 months). The frequency of resolution of hematuria after initial TAE without recurrence was greater after treatment by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than by PVA (100.0% vs 80.0%, respectively; <i>p</i> = .03). At 12-month follow-up, the frequency of complete resolution of flank pain was higher after treatment by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than by PVA (100.0% vs 75.0%, <i>p</i> = .03). Mean reduction in AML volume at 36 months or longer after TAE versus at baseline was greater in patients treated by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than in those treated by PVA (98.0% vs 85.7%, respectively; <i>p</i> = .04). The frequency of complete response by modified RECIST (mRECIST) criteria at 36 months or longer after TAE was greater in patients treated by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than by PVA (94.6% vs 74.3%, <i>p</i> = .04). The rate of repeat TAE was higher among patients treated by PVA than among those treated by Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion (25.7% vs 8.1%, <i>p</i> = .04). <b>CONCLUSION.</b> Superior outcomes after TAE of AML were achieved using Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion than using PVA. <b>CLINICAL IMPACT.</b> TAE using a combination of Lipiodol-bleomycin emulsion and NBCA-Lipiodol emulsion is a safe and effective treatment option for large or symptomatic AMLs. <b>TRIAL REGISTRATION.</b> Chinese Clinical Trial Registry ChiCTR2100053296.