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.
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.
J Vasc Interv Radiol. 2019 Nov;30(11):1798-1806. doi: 10.1016/j.jvir.2019.06.019. Epub 2019 Oct 3.
To compare balloon occlusion prostatic artery embolization (bPAE) with conventional microcatheter PAE (cPAE).
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.
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 cm ± 51.6 (18.2%) after cPAE and 6.15 cm ± 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.
bPAE is as effective as cPAE in treating benign prostatic hyperplasia with a potential to reduce nontarget embolization.
比较球囊阻断前列腺动脉栓塞术（bPAE）与传统微导管前列腺动脉栓塞术（cPAE）。
在这项单中心试验中，2017 年 11 月至 2018 年 11 月，89 例有症状的良性前列腺增生患者被随机分为 cPAE 组（n=43）或 bPAE 组（n=46）。所有患者均接受 300-500μm Embosphere 微球栓塞治疗，并在 PAE 前、1 个月和 6 个月进行评估。主要结局指标为国际前列腺症状评分（IPSS）自基线的变化。采用学生 t 检验比较组间自基线的变化，采用配对 t 检验比较组内自基线的变化。
基线时，两组无差异（P＞.05）。4 例接受 cPAE 的患者和 3 例接受 bPAE 的患者行单侧 PAE（9.30%和 6.52%，P=.708）。两组的手术和透视时间、剂量面积乘积、空气比释动能、栓塞体积和 PAE 后 24 小时平均前列腺特异性抗原（PSA）均无差异（P＞.05）。cPAE 组有 6 例和 bPAE 组有 4 例患者使用了螺旋圈（14.0%和 8.70%，P=.51）。PAE 后 6 个月评估显示，cPAE 后平均 IPSS 降低 7.58±6.88，bPAE 后降低 8.30±8.12（P=.65）；cPAE 后前列腺体积平均减少 21.9cm±51.6（18.2%），bPAE 后减少 6.15cm±14.6（7.3%）（P=.05）；cPAE 后平均 PSA 降低 0.9ng/mL±2.22，bPAE 后降低 0.22ng/mL±1.65（P=.10）。仅在接受 cPAE 的患者中（11.9%，P=.01）记录到阴茎皮肤损伤（n=3）和直肠出血（n=2）。无重大不良事件发生。
bPAE 治疗良性前列腺增生与 cPAE 同样有效，具有减少非靶向栓塞的潜力。
