Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study.

PURPOSE: To describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE). MATERIALS AND METHODS: This was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics. RESULTS: Four hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all p < 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all p < 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE. CONCLUSION: PAE is a safe and effective treatment for symptomatic BPH and LUTS. Level of Evidence Level 3 Trial registration ClinicalTrials.gov NCT03527589.

Venous recanalisation in the setting of post-thrombotic syndrome: An expert consensus from the French Society of Vascular Medicine (SFMV) and the French Society of Cardiovascular Imaging and Interventional Radiology (SFICV).

Several aspects of the management of post-thrombotic syndrome (PTS) are still a matter of debate, or not yet addressed in international guidelines. The objective of this expert consensus from the French Society of Vascular Medicine (SFMV) and the French Society of Cardiovascular Imaging (SFICV) was to define the main elements of diagnosis and treatment of this syndrome, and to develop a proposal for its preoperative, procedural and follow-up management. In this consensus, the following issues were addressed: clinical and ultrasound diagnosis; pre-procedural workup; indications and contraindications to venous recanalisation; procedures; clinical and duplex ultrasound reports; follow-up; long-term treatment; management of great saphenous vein incompetency; anticoagulant and antiplatelet therapy after venous stenting.

Clinical value of sequential circulating tumor DNA analysis using next-generation sequencing and epigenetic modifications for guiding thermal ablation for colorectal cancer metastases: a prospective study.

INTRODUCTION: While thermal ablation is now a standard treatment option for oligometastatic colorectal cancer patients, selecting those who will benefit most from locoregional therapies remains challenging. This proof-of-concept study is the first to assess the feasibility of routine testing of ctDNA before and after thermal ablation with curative intent, analyzed by next-generation sequencing (NGS) and methylation specific digital droplet PCR (ddPCR). Our prospective study primary objective was to assess the prognostic value of ctDNA before thermal ablation. METHODS: This single-center prospective study from November 2021 to June 2022 included colorectal cancer patients referred for curative-intent thermal ablation. Cell-free DNA was tested at different time points by next-generation sequencing and detection of WIF1 and NPY genes hypermethylation using ddPCR. The ctDNA was considered positive if either a tumor mutation or hypermethylation was detected; recurrence-free survival was used as the primary endpoint. RESULTS: The study enrolled 15 patients, and a total of 60 samples were analyzed. The median follow-up after ablation was 316 days, and median recurrence-free survival was 250 days. CtDNA was positive for 33% of the samples collected during the first 24 h. The hazard ratio for progression according to the presence of baseline circulating tumor DNA was estimated at 0.14 (CI 95%: 0.03-0.65, p = 0.019). The dynamics are provided, and patients with no recurrence were all negative at H24 for ctDNA. DISCUSSION: This study shows the feasibility of routine testing of ctDNA before and after thermal ablation with curative intent. We report that circulating tumor DNA is detectable in patients with low tumor burden using 2 techniques. This study emphasizes the potential of ctDNA for discerning patients who are likely to benefit from thermal ablation from those who may not, which could shape future referrals. The dynamics of ctDNA before and after ablation shed light on the need for further research and larger studies.

Society of Interventional Radiology Research Reporting Standards for Genicular Artery Embolization.

Genicular artery embolization (GAE) is an emerging, minimally invasive therapy to address the global burden of knee osteoarthritis (OA) and the unmet needs for medically refractory disease. Although total knee arthroplasty has been a standard intervention for severe cases, GAE is developing into a promising alternative, particularly for patients ineligible for or unwilling to undergo surgery. GAE targets the inflammatory cascade underlying OA pathophysiology by arresting neoangiogenesis and preventing pathological neoinnervation, offering potential pain relief. Although early studies have established safety and short-term effectiveness, ensuing studies are needed to validate long-term safety, durability, and comparative effectiveness and to optimize patient selection, embolic agent selection, and administration techniques. Standardized reporting guidelines are therefore essential to enhance transparency and reproducibility across clinical trials, facilitating data aggregation and comparison. This Society of Interventional Radiology (SIR)-endorsed reporting standards consensus document provides a framework to harmonize future research efforts and to improve the interpretation of outcomes.

Outcomes and Comparative Analysis of the Initial Results of Standard Balloon Angioplasty Versus Drug-Coated Balloons Alone Versus in Association With Laser-Excimer Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis (INTACT).

BACKGROUND: Despite improved patency with newer-generation nitinol stents, one-half of patients will require secondary interventions for in-stent restenosis (ISR). The best treatment strategy remains unclear. This study aimed to compare drug-coated balloons (DCBs) used alone or in association with excimer laser atherectomy (ELA) to simple percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal-ISR. METHODS: The INTACT trial is a multicenter, prospective, triple-arm randomized trial conducted across 14 centers from December 2015 to November 2019. Patients Rutherford Class 2-5 with ISR≥70% were followed-up for 18 months. The primary efficacy endpoint was recurrent ISR>70% by duplex ultrasound analysis. The primary safety endpoint was major adverse events (MAEs) defined as death, major amputation, or target lesion revascularization (TLR). RESULTS: Around 134 subjects were randomized to PTA alone (n=41), PTA+DCB (n=43) or PTA+ELA+DCB (n=50). Procedural success was similar (p=.74), as was clinical success (p=.17). The number of recurrent ISR>70% decreased after PTA+ELA+DCB (30.0%; p=.04) and PTA+DCB (30.2%; p=.05) compared to PTA alone (51.2%). Primary patency was higher after PTA+ELA+DCB (log-rank p=.04) and PTA+DCB (log-rank p=.02) compared to PTA alone at 12 months (78.7% and 70.4% vs 61.5%) and 18 months (61.6% and 67.7% vs 37.3%). Freedom from MAEs was lower after PTA+DCB (27.9%) compared to PTA alone (53.7%; p=.02) but did not differ with PTA+ELA+DCB (40.0%). It was primarily driven by TLR; 2 major amputations occurred after PTA+ELA+DCB (4.0%; p=.18). CONCLUSION: This independent study demonstrated a decrease in recurrent ISR>70% and increase in primary patency up to 18 months after PTA+ELA+DCB and PTA+DCB compared to PTA alone in the treatment of FP-ISR. It did not show an increase in MAEs but could have lacked power. CLINICAL IMPACT: This multicenter, prospective, triple-arm randomized, controlled trial focuses on the results of adjunctive therapies, such as excimer laser atherectomy (ELA) and/or drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR) in femoropopliteal lesions in 134 patients. It has the originality of being an independent study funded by a grant from the French Ministry of Health. This study confirms a significant decrease in recurrent ISR >70% and increase in primary patency up to 18 months after the use of ELA+DCB and DCBs compared to simple percutaneous transluminal angioplasty in the treatment of femoropopliteal ISR without an increase in major adverse events.

Perioperative management of venous recanalization in a patient with inherited antithrombin deficiency: case report.

Background: Inherited antithrombin (AT) deficiency (ATD) is a severe thrombophilia causing venous thromboembolism, which can be complicated by postthrombotic syndrome (PTS). Venous recanalization, used to treat PTS, often requires a temporary withdrawal of anticoagulant therapy. In ATD patients, there is a risk of insufficient perioperative anticoagulation due to altered heparin response. Key Clinical Question: There is no consensus on how to manage perioperative anticoagulation in ATD patients. Clinical Approach: Warfarin-unfractionated heparin transition could be a more reliable strategy than low-molecular-weight heparin transition because unfractionated heparin anti-Xa activity not only reflects heparin-bound AT but also AT's activity, which correlates strongly with therapeutic anticoagulation. Biological monitoring could thus decrease the number of plasma-derived AT supplementation. Conclusion: This study describes a successful perioperative management of anticoagulation for venous recanalization that could be suggested to type 1 ATD patients with PTS.

Multicenter Quantification of Radiation Exposure and Associated Risks for Prostatic Artery Embolization in 1476 Patients.

Background Prostatic artery embolization (PAE) is a safe, minimally invasive angiographic procedure that effectively treats benign prostatic hyperplasia; however, PAE-related patient radiation exposure and associated risks are not completely understood. Purpose To quantify radiation dose and assess radiation-related adverse events in patients who underwent PAE at multiple centers. Materials and Methods This retrospective study included patients undergoing PAE for any indication performed by experienced operators at 10 high-volume international centers from January 2014 to May 2021. Patient characteristics, procedural and radiation dose data, and radiation-related adverse events were collected. Procedural radiation effective doses were calculated by multiplying kerma-area product values by an established conversion factor for abdominopelvic fluoroscopy-guided procedures. Relationships between cumulative air kerma (CAK) or effective dose and patient body mass index (BMI), fluoroscopy time, or radiation field area were assessed with linear regression. Differences in radiation dose stemming from radiopaque prostheses or fluoroscopy unit type were assessed using two-sample t tests and Wilcoxon rank sum tests. Results A total of 1476 patients (mean age, 69.9 years ± 9.0 [SD]) were included, of whom 1345 (91.1%) and 131 (8.9%) underwent the procedure with fixed interventional or mobile fluoroscopy units, respectively. Median procedure effective dose was 17.8 mSv for fixed interventional units and 12.3 mSv for mobile units. CAK and effective dose both correlated positively with BMI (R2 = 0.15 and 0.17; P < .001) and fluoroscopy time (R2 = 0.16 and 0.08; P < .001). No radiation-related 90-day adverse events were reported. Patients with radiopaque implants versus those without implants had higher median CAK (1452 mGy [range, 900-2685 mGy] vs 1177 mGy [range, 700-1959 mGy], respectively; P = .01). Median effective dose was lower for mobile than for fixed interventional systems (12.3 mSv [range, 8.5-22.0 mSv] vs 20.4 mSv [range, 13.8-30.6 mSv], respectively; P < .001). Conclusion Patients who underwent PAE performed with fixed interventional or mobile fluoroscopy units were exposed to a median effective radiation dose of 17.8 mSv or 12.3 mSv, respectively. No radiation-related adverse events at 90 days were reported. © RSNA, 2024 See also the editorial by Mahesh in this issue.

Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Ilio-femoral venous stenting for post-thrombotic syndrome in women of childbearing age: efficacy and impact of pregnancy-a multi-center study by the French Society of Cardiovascular Imaging.

OBJECTIVE: We investigated the efficacy of iliofemoral venous stenting in women of childbearing age treated for post-thrombotic syndrome (PTS) and assessed the influence of pregnancy on stent occlusion. METHODS: A retrospective analysis was conducted on women of childbearing age who underwent endovascular stenting for PTS due to chronic iliocava occlusion across 15 centers from 2009 to 2020. The study assessed pregnancy rates, primary patency rates, secondary patency rates, and clinical efficacy using the Villalta score for PTS severity and the Chronic Venous Disease Quality of Life Questionnaire - version 20 (CIVIQ-20), 6-12 months after the procedure. The impact of pregnancy on stent occlusion was analyzed using classical and multi-state survival analyses. Prophylactic low-molecular-weight heparin or fondaparinux was administered to patients during pregnancy until 6 weeks post-partum. RESULTS: In total, 211 women with PTS underwent endovascular stenting, with a median age of 31 years (range: 16-42). Following recanalization, significant improvements were observed in the Villalta score (p < 0.0001) and the CIVIQ-20 score (p < 0.0001). Thirty-seven (17.6%) women became pregnant and 49 (23.2%) experienced stent occlusions. The 1-year and 5-year occlusion-free survival probabilities were 80.6% (95% confidence interval [CI]: 75.1-86.4%) and 66.6% (95% CI: 57.4-77.4%), respectively. There was no significant association between pregnancy and stent occlusion-free survival (hazard ratio = 1.00 [95% CI: 0.11-8.92], p = 0.9930). CONCLUSION: Iliofemoral venous stenting in women of childbearing age was an effective treatment for post-thrombotic syndrome, and it did not increase the risk for stent occlusion during pregnancy when accompanied by appropriate anticoagulation. CLINICAL RELEVANCE STATEMENT: This study demonstrates that pregnancy following iliofemoral venous stenting for post-thrombotic syndrome does not elevate the risk for stent occlusion. KEY POINTS: • The severity of post-thrombotic syndrome and the quality of life, as measured using the Villalta score and Chronic Venous Disease Quality of Life Questionnaire - version 20, respectively, showed significant improvements 6-12 months after iliofemoral venous stenting. • The occurrence of pregnancy after recanalization in women of childbearing age did not lead to a significant increase in the risk for stent occlusion.

Editor's Choice -- Survival, Limb Salvage, and Management of Patients with Lower Limb Acute Ischaemia: A French National Retrospective Observational Study.

OBJECTIVE: The aim was to describe the baseline characteristics of French patients referred with acute limb ischaemia (ALI), and their clinical management and outcome (death, amputation). METHODS: This retrospective observational cohort study used the National Health Data System. All adults hospitalised for ALI who underwent revascularisation with an endovascular or open surgical approach between 1 January 2015 and 31 December 2020 were included and followed up until death or the end of the study (31 December 2021). A one year look back period was used to capture patients' medical history. The risks of death, and major and minor amputations were described using Kaplan-Meier and Aalen-Johansen estimators. A Cox model was used to report the adjusted association between groups and risk of death and Fine-Gray models for the risk of amputations considering the competing risk of death. RESULTS: Overall, 51 390 patients (median age 70 years, 69% male) were included and had a median follow up of 2.7 years: 39 411 (76.7%) were treated with an open approach and 11 979 (23.3%) with a percutaneous endovascular approach. The preferred approach for the revascularisation varied between French regions. The one year overall survival was 78.0% and 85.2% in the surgery and endovascular groups, respectively. The surgery group had a higher risk of death (hazard ratio [HR] 1.17, 95% CI 1.12 - 1.21), a higher risk of major amputation (sub-distribution HR 1.20, 95% CI 1.10 - 1.30) and lower risk of minor amputation (sub-distribution HR 0.66, 95% CI 0.60 - 0.71) than the endovascular group. Diabetes and dialysis increased the risk of major amputation by 52% and 78%, respectively. Subsequent ALI was the third most common cause of hospital re-admission within one year. CONCLUSION: ALI remains a condition at high risk of death and amputation. Individual risk factors and ALI severity need to be considered to choose between approaches. Continued prevention efforts, improved management, and access to the most suitable approach are necessary.

Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA). MATERIALS AND METHODS: This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0-100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria. RESULTS: Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function. CONCLUSION: GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.

Repeat Prostatic Artery Embolization with the Addition of a Liquid Embolic Agent: Short-term Results.

RATIONALE AND OBJECTIVES: The long-term effectiveness of prostatic artery embolization (PAE) can be hampered by the recanalization of the previously embolized prostatic arteries (PA). The use of a liquid embolic agent (LEA) could limit this risk. The purpose of this study was to assess the safety and efficacy of repeat PAE (rePAE) using a LEA (Squid Peri) coupled with microspheres in patients experiencing recurring symptoms after initial embolization. MATERIALS AND METHODS: This retrospective single-center study included all consecutive patients who underwent rePAE using Squid Peri coupled with microspheres. Angiographic patterns of prostatic revascularization were identified. Outcomes were assessed at the 3-month follow-up using the International Prostate Symptom Score (IPSS) and the Quality of Life (QoL) score. The primary endpoint was clinical success defined as an IPSS < 18 with > 25% decrease and a QoL score ≤ 3 with ≥ 1 point decrease. Safety was assessed by using the modified Clavien-Dindo classification. RESULTS: 30 consecutive men (mean age: 67.1 ± 9.5 years) were included. Recanalization of the previously embolized PA was found in 83.3% of patients. Technical success was 93.3%. Median follow-up was 4.9 months [IQR: 3.9 - 9.8]. Clinical success rate was 76.7%, with a mean decrease in IPSS of -9.3 ± 7.3 (p < 0.001) and a median decrease in QoL of -2 [IQR: - 4 - - 1] (p < 0.001). One patient presented with an acute urinary retention requiring readmission (grade IIIa complication). CONCLUSION: Repeat PAE using Squid Peri coupled with microspheres is safe and effective for patients with recurring symptoms after initial embolization.

Exploring a Novel Technique to Tackle the Shortage of Devices for Hepatic Arterial Infusion Chemotherapy: Early Results of an Alternate Approach for Percutaneous Arterial Port Catheter Placement.

Dedicated catheters for hepatic arterial infusion chemotherapy were removed from the market. The purpose of this study was to assess the results of a novel approach to overcome the shortage of dedicated catheters for hepatic arterial infusion chemotherapy in the treatment of colorectal cancer liver metastases. We retrospectively included patients who underwent a percutaneous placement of a hepatic intra-arterial port catheter in a single tertiary center from February 2021 to June 2022. We examined the patient baseline characteristics, technical features of the modified procedures, technical success rates, complications and oncological outcomes. Fourteen patients (median age: 60 years; q1 = 54; q3 = 70; range: 53-81 years) underwent 15 modified procedures. The main modification of our placement technique consisted of the use of an indwelling 5-Fr Vertebral catheter, on the tip of which we created a two-sided additional lateral hole. The catheter was connected to a pediatric port. The primary success rate was 100%, and the secondary success rate was 93.3%. There were two late major complications, graded IIIa according to the Clavien-Dindo classification. The median liver progression free survival was 6.1 months (q1 = 2.5; q3 = 7.2; range: 1.3-11.6). Our experience suggests that the derived utilization of the devices used routinely in interventional radiology provides an effective solution that can compensate for the shortage of dedicated devices.

Endovascular Thrombectomy for Acute Iliofemoral Deep Venous Thrombosis Through a Jugular Approach with a Rotational Device.

PURPOSE: To report the effectiveness of pharmacomechanical catheter-directed thrombolysis (PCDT) in the management of acute iliofemoral deep venous thrombosis (DVT) via the jugular vein using a slow rotation and large-tip device (SRD) in a large cohort of patients. MATERIAL AND METHODS: From 2011 to 2021, 277 patients (mean age 45 years, 59.2% women) were treated in 6 centres with PCDT for ilio-fémoral DVT. PCDT was performed via the jugular vein and consisted of one session of fragmentation-fibrinolysis, aspiration and, if needed, angioplasty with stenting. The aim of PCDT was to achieve complete clearance of the venous thrombosis and to restore iliofemoral patency. Residual thrombotic load was assessed by angiography, venous patency by duplex ultrasound and clinical effectiveness by the rate of post-thrombotic syndrome (Villalta score > 4). RESULTS: All patients were treated via the jugular vein using an SRD, and all but one were treated with fibrinolysis. Angioplasty with stenting was performed in 84.1% of patients. After the procedure, the residual thrombotic load at the ilio-fémoral region was < 10% in 96.1% of patients. The rate of major complications was 1.8% (n = 5), the rate of minor complications was 4% (n = 11), and one patient died from pulmonary embolism (0.4%) At a median follow-up of 24 months, primary and secondary iliofemoral patency was 89.6% and 95.8%, respectively. The rate of PTS was 13.8% at 12 months. CONCLUSION: PCDT via the jugular vein using an SRD is an efficient treatment for acute iliofemoral DVT and results in high long-term venous patency and low PTS rates. Level of evidence Level 4, Case series.

Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.

Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively. Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months. Funding: French Ministry of Health and a complementary grant from Merit Medical.