Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial
Marc Sapoval, Nicolas Thiounn, A. Descazeaud, Carole Déan, A. Ruffion, G. Pagnoux, Ricardo Codas Duarte, G. Robert, F. Petitpierre, G. Karsenty, Vincent Vidal, T. Murez, Hélène Vernhet‐Kovacsik, Alexandre de la Taille, Hicham Kobeiter, Romain Mathiéu, Jean-François Heautot, S. Droupy, Julien Frandon, Nicolas Barry Delongchamps, Virginie Korb‐Savoldelli, Isabelle Durand‐Zaleski, Héléna Pereira, Gilles Châtellier, Olivier Pellerin, Brigitte Sabatier, Charles Dariane, Benjamin Gabay, Paul C. Moldovan, Olivier Rouvière, Jean Champagnac, Samuel Lagabrielle, N. Grenier, R. Boissier, É. Lechevallier, Jean Izaaryene, Farouk Tradi, Raphaele Arrouasse, J. Defontaines, X. Joseph, Philippe Le Corvoisier, É. Sbidian, C. Champy, M. Chiaradia, A. Chevrot, Cyrille Blion, J. Goupil, Julie Bulsei, Alexandra Vappereau
Abstract
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.