A French group of interventional radiologists and urologists has recently published the results of its randomised, multicentre, open-label, phase 3 superiority trial of prostate artery embolization (PAE) versus medical therapy (PARTEM) in The Lancet. The group, of whom Marc Sapoval (Hôpital Européen Georges Pompidou, Paris, France) is the corresponding author, states in its publication that the PARTEM trial met its primary endpoint of clinically significant superior reduction of International Prostate Symptom Score (IPSS) after PAE at nine months compared to following combined medical therapy (CT), “in patients who failed to improve after single alpha-blockers therapy”.
The authors detail that “the aim of the trial was to compare effect on lower urinary tract symptoms (LUTS) of PAE versus medical treatment in patients with symptomatic benign prostate hyperplasia (BPH) who still complained of bothersome LUTS despite >1 month of treatment with alpha blockers”.
Also noted in the introduction to the paper was the fact that, to the authors’ knowledge, “this is the first randomised trial showing that PAE provides a clinically significant benefit over [CT]”. Additionally, they found that embolization provided the PAE cohort with better sexual function compared to the CT arm.
The authors set out the background to their study as being that PAE is an “increasingly recognised treatment option” owing to its “good risk/efficacy profile”.
Sapoval et al carried out their study in 90 randomised patients (aged 50 to 85 years) between September 2016 and February 2020, of whom 44 and 23 patients were assessed for the primary endpoint in the PAE and CT groups, respectively. The study took place across 10 French hospitals and the population was selected based on having bothersome LUTS defined by an IPSS >11, quality of life >3 (according to the last question of the IPSS questionnaire), and BPH ≥50 ml resistant to alpha-blocker monotherapy.
The CT group received oral dutasteride 0.5mg/tamsulosin hydrochloride 0.4mg per day.
The authors also outline that four patients in the PAE group underwent unilateral embolization, of whom two underwent a second attempt at bilateral PAE. “Unilateral embolization was done when it was impossible to catheterise the prostatic artery selectively,” they elaborate, explaining that this was related to excessive angulation, calcification or stenosis.
The PAE cohort’s nine-month change in IPSS was −10.0 (95% confidence interval [CI]: −11.8 to −8.3), versus −5.7 (95% CI: −7.5 to −3.8) in the CT group. The authors go on to note no treatment-related adverse events or hospitalisation for either group, and the respective number of invasive prostate retreatments in the PAE versus CT groups at nine months was five versus 18.
From their study, Sapoval et al have been able to conclude that “in patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptom benefits than CT up to 24 months”.
Moreover, as part of the study, the authors carried out an economic evaluation, as they recognise that “the choice of an optimal treatment strategy for BPH is also informed by economic data due to the high prevalence of the condition and the costs of surgery”. Sapoval et al add that “the selection outcome for the economic evaluation was driven by the clinical relevance of treatment success at nine months and the limited sensitivity of generic quality of life measures EQ-5D over a short period”.
Sapoval gave the following statement to Interventional News regarding the importance of his and colleagues’ findings: “This study helps to advise patients suffering from bothersome LUTS related to BPH >50 ml that PAE may be a valid option able to provide significant symptom relief.”
