The Lancet Regional Health. Europe (Aug 2023)
Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trialResearch in context
- Marc Sapoval,
- Nicolas Thiounn,
- Aurélien Descazeaud,
- Carole Déan,
- Alain Ruffion,
- Gaële Pagnoux,
- Ricardo Codas Duarte,
- Grégoire Robert,
- Francois Petitpierre,
- Gilles Karsenty,
- Vincent Vidal,
- Thibaut Murez,
- Hélène Vernhet-Kovacsik,
- Alexandre de la Taille,
- Hicham Kobeiter,
- Romain Mathieu,
- Jean-Francois Heautot,
- Stéphane Droupy,
- Julien Frandon,
- Nicolas Barry Delongchamps,
- Virginie Korb-Savoldelli,
- Isabelle Durand-Zaleski,
- Helena Pereira,
- Gilles Chatellier,
- Olivier Pellerin,
- Brigitte Sabatier,
- Charles Dariane,
- Benjamin Gabay,
- Paul Cezar Moldovan,
- Olivier Rouvière,
- Jean Champagnac,
- Samuel Lagabrielle,
- Nicolas Grenier,
- Romain Boissier,
- Éric Lechevallier,
- Jalal-Jean Izaaryene,
- Farouk Tradi,
- Raphaele Arrouasse,
- Julien Defontaines,
- Xavier Joseph,
- Philippe Le Corvoisier,
- Emilie Sbidian,
- Cécile Champy,
- Mélanie Chiaradia,
- Armand Chevrot,
- Cyrille Blion,
- Jean Goupil,
- Julie Bulsei,
- Alexandra Vappereau
Affiliations
- Marc Sapoval
- Université de Paris Cité, PARCC - INSERM Unité-970, Paris, France; Department of Vascular and Oncological Interventional Radiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France; Corresponding author. Department of Vascular and Oncological Interventional Radiology, Hôpital Européen Georges Pompidou, 20 rue Leblanc, 75015 Paris, France.
- Nicolas Thiounn
- Department of Urology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France
- Aurélien Descazeaud
- Centre Hospitalier Universitaire de Limoges, Department of Urology, Limoges, France
- Carole Déan
- Department of Vascular and Oncological Interventional Radiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France
- Alain Ruffion
- Department of Urology, Hospices Civils de Lyon, Hôpital Lyon Sud, Pierre-Bénite, France; Université Lyon 1, Faculté de médecine Lyon Sud, Equipe 2 - Centre d’Innovation en Cancérologie de Lyon (EA 3738 CICLY), Lyon, France
- Gaële Pagnoux
- Department of Uroradiology, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France
- Ricardo Codas Duarte
- Department of Urology and Transplantation, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France
- Grégoire Robert
- Centre Hospitalier Universitaire de Bordeaux, Department of Urology, Université de Bordeaux, Bordeaux, France
- Francois Petitpierre
- Centre Hospitalier Universitaire de Bordeaux, Department of Diagnostic and Therapeutic Imaging, Bordeaux, France
- Gilles Karsenty
- Department of Urology and Renal Transplantation, Assistance publique-Hôpitaux de Marseille, Hôpital de la Conception, Aix-Marseille Université, Marseille, France
- Vincent Vidal
- Centre Hospitalier Universitaire de la Timone, Interventional Radiology Section, Department of Medical Imaging, Assistance publique-Hôpitaux de Marseille, Marseille, France; Aix-Marseille Université, LiiE, CERIMED, Marseille, France
- Thibaut Murez
- Centre Hospitalier Universitaire de Montpellier, Department of Urology and Renal Transplantation, Montpellier, France
- Hélène Vernhet-Kovacsik
- Centre Hospitalier Universitaire de Montpellier, Department of Diagnostic and Interventional Radiology, Hôpital Arnaud-de-Villeneuve, Montpellier, France
- Alexandre de la Taille
- Department of Urology, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Henri Mondor, Créteil, France
- Hicham Kobeiter
- Department of Diagnostic and Interventional Medical Imaging, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Henri Mondor, Université Paris Est, Créteil, France
- Romain Mathieu
- Centre Hospitalier Universitaire de Rennes, Department of Urology, Rennes, France
- Jean-Francois Heautot
- Centre Hospitalier Universitaire de Rennes, Vascular Medicine Unit, Department of Radiology, Hôpital Pontchaillou, Rennes, France
- Stéphane Droupy
- Centre Hospitalier Universitaire De Nîmes, Department of Urology and Andrology, Université de Montpellier, Nîmes, France
- Julien Frandon
- Centre Hospitalier Universitaire De Nîmes, Department of Medical Imaging, Université de Montpellier, Nîmes, France; Medical Imaging Group Nîmes, IMAGINE, Nîmes, France
- Nicolas Barry Delongchamps
- Université de Paris Cité, Inserm Unit U1151, Paris, France; Department of Urology, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France
- Virginie Korb-Savoldelli
- Department of Pharmacy, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Paris, France; Department of Clinical Pharmacy, Université Paris-Saclay, Faculté de Pharmacie, Chatenay-Malabry, France
- Isabelle Durand-Zaleski
- Université de Paris Cité, CRESS, INSERM UMR1153, INRA, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital de l'Hôtel Dieu, Université Paris Est Créteil, URCEco, Paris, France
- Helena Pereira
- INSERM, Centre d'investigation Clinique 1418 Épidémiologie Clinique, Paris, France; Clinical Research Unit, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Paris, France
- Gilles Chatellier
- INSERM, Centre d'investigation Clinique 1418 Épidémiologie Clinique, Paris, France; Clinical Research Unit, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Paris, France
- Olivier Pellerin
- Brigitte Sabatier
- Charles Dariane
- Benjamin Gabay
- Paul Cezar Moldovan
- Olivier Rouvière
- Jean Champagnac
- Samuel Lagabrielle
- Nicolas Grenier
- Romain Boissier
- Éric Lechevallier
- Jalal-Jean Izaaryene
- Farouk Tradi
- Raphaele Arrouasse
- Julien Defontaines
- Xavier Joseph
- Philippe Le Corvoisier
- Emilie Sbidian
- Cécile Champy
- Mélanie Chiaradia
- Armand Chevrot
- Cyrille Blion
- Jean Goupil
- Julie Bulsei
- Alexandra Vappereau
- Journal volume & issue
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Vol. 31
p. 100672
Abstract
Summary: 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.
