Tiago Bilhim1, Nuno Vasco Costa2, Daniel Torres2, João Pisco3, Sandra Carmo4, António G Oliveira5. 1. Interventional Radiology Unit, Saint Louis Hospital, R. Luz Soriano 182, Lisbon 1200-249, Portugal; Interventional Radiology Unit, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal; Nova Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal. Electronic address: tiagobilhim@hotmail.com. 2. Interventional Radiology Unit, Saint Louis Hospital, R. Luz Soriano 182, Lisbon 1200-249, Portugal; Interventional Radiology Unit, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal; Nova Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal. 3. Interventional Radiology Unit, Saint Louis Hospital, R. Luz Soriano 182, Lisbon 1200-249, Portugal. 4. Interventional Radiology Unit, Saint Louis Hospital, R. Luz Soriano 182, Lisbon 1200-249, Portugal; Radiology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal. 5. Pharmacy Department, Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
Abstract
PURPOSE: To compare balloon occlusion prostatic artery embolization (bPAE) with conventional microcatheter PAE (cPAE). MATERIALS AND METHODS: In this single-center trial, between November 2017 and November 2018, 89 patients with symptomatic benign prostatic hyperplasia were randomly assigned to cPAE (n = 43) or bPAE (n = 46). All patients received embolization with 300-500 μm Embosphere microspheres and were evaluated before and 1 and 6 months after PAE. Primary outcome measure was change from baseline in International Prostate Symptom Score (IPSS). Student t test was used for between-group comparisons of change from baseline, and paired t test was used for within-group comparisons. RESULTS: At baseline, groups were identical (P > .05). Unilateral PAE was performed in 4 patients receiving cPAE and 3 patients receiving bPAE (9.30% and 6.52%, P = .708). Procedural and fluoroscopy times, dose area product, air kerma, embolic volume, and mean prostate-specific antigen (PSA) 24 hours after PAE did not differ between groups (P > .05). Coils were used in 6 patients receiving cPAE and 4 patients receiving bPAE (14.0% and 8.70%, P = .51). Assessments at 6 months after PAE showed mean IPSS reduction was 7.58 ± 6.88 after cPAE and 8.30 ± 8.12 after bPAE (P = .65); mean prostate volume reduction was 21.9 cm3 ± 51.6 (18.2%) after cPAE and 6.15 cm3 ± 14.6 (7.3%) after bPAE (P = .05); mean PSA reduction was 0.9 ng/mL ± 2.22 after cPAE and 0.22 ng/mL ± 1.65 after bPAE (P = .10). Penile skin lesions (n = 3) and rectal bleeding (n = 2) were documented only in patients receiving cPAE (11.9%, P = .01). No major adverse events occurred. CONCLUSIONS:bPAE is as effective as cPAE in treating benign prostatic hyperplasia with a potential to reduce nontarget embolization.
RCT Entities:
PURPOSE: To compare balloon occlusion prostatic artery embolization (bPAE) with conventional microcatheter PAE (cPAE). MATERIALS AND METHODS: In this single-center trial, between November 2017 and November 2018, 89 patients with symptomatic benign prostatic hyperplasia were randomly assigned to cPAE (n = 43) or bPAE (n = 46). All patients received embolization with 300-500 μm Embosphere microspheres and were evaluated before and 1 and 6 months after PAE. Primary outcome measure was change from baseline in International Prostate Symptom Score (IPSS). Student t test was used for between-group comparisons of change from baseline, and paired t test was used for within-group comparisons. RESULTS: At baseline, groups were identical (P > .05). Unilateral PAE was performed in 4 patients receiving cPAE and 3 patients receiving bPAE (9.30% and 6.52%, P = .708). Procedural and fluoroscopy times, dose area product, air kerma, embolic volume, and mean prostate-specific antigen (PSA) 24 hours after PAE did not differ between groups (P > .05). Coils were used in 6 patients receiving cPAE and 4 patients receiving bPAE (14.0% and 8.70%, P = .51). Assessments at 6 months after PAE showed mean IPSS reduction was 7.58 ± 6.88 after cPAE and 8.30 ± 8.12 after bPAE (P = .65); mean prostate volume reduction was 21.9 cm3 ± 51.6 (18.2%) after cPAE and 6.15 cm3 ± 14.6 (7.3%) after bPAE (P = .05); mean PSA reduction was 0.9 ng/mL ± 2.22 after cPAE and 0.22 ng/mL ± 1.65 after bPAE (P = .10). Penile skin lesions (n = 3) and rectal bleeding (n = 2) were documented only in patients receiving cPAE (11.9%, P = .01). No major adverse events occurred. CONCLUSIONS:bPAE is as effective as cPAE in treating benign prostatic hyperplasia with a potential to reduce nontarget embolization.
Authors: Gregory Amouyal; Louis Tournier; Constance De Margerie-Mellon; Atanas Pachev; Jessica Assouline; Damien Bouda; Cédric De Bazelaire; Florent Marques; Solenne Le Strat; François Desgrandchamps; Eric De Kerviler Journal: J Pers Med Date: 2022-07-31