Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.
5- alpha-reductase inhibitors
Alpha-blockers
Benign prostatic hyperplasia
Cost
Economics
Erectile function
International prostatic symptom score
Lower urinary tract symptoms
Prostatic artery embolisation
Journal
The Lancet regional health. Europe
ISSN: 2666-7762
Titre abrégé: Lancet Reg Health Eur
Pays: England
ID NLM: 101777707
Informations de publication
Date de publication:
Aug 2023
Aug 2023
Historique:
received:
10
05
2023
revised:
06
06
2023
accepted:
07
06
2023
medline:
7
7
2023
pubmed:
7
7
2023
entrez:
7
7
2023
Statut:
epublish
Résumé
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. 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. 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. 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. French Ministry of Health and a complementary grant from Merit Medical.
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
French Ministry of Health and a complementary grant from Merit Medical.
Identifiants
pubmed: 37415648
doi: 10.1016/j.lanepe.2023.100672
pii: S2666-7762(23)00091-1
pmc: PMC10320610
doi:
Banques de données
ClinicalTrials.gov
['NCT02869971']
Types de publication
Journal Article
Langues
eng
Pagination
100672Investigateurs
Olivier Pellerin
(O)
Brigitte Sabatier
(B)
Charles Dariane
(C)
Benjamin Gabay
(B)
Paul Cezar Moldovan
(PC)
Olivier Rouvière
(O)
Jean Champagnac
(J)
Samuel Lagabrielle
(S)
Nicolas Grenier
(N)
Romain Boissier
(R)
Éric Lechevallier
(É)
Jalal-Jean Izaaryene
(JJ)
Farouk Tradi
(F)
Raphaele Arrouasse
(R)
Julien Defontaines
(J)
Xavier Joseph
(X)
Philippe Le Corvoisier
(P)
Emilie Sbidian
(E)
Cécile Champy
(C)
Mélanie Chiaradia
(M)
Armand Chevrot
(A)
Cyrille Blion
(C)
Jean Goupil
(J)
Julie Bulsei
(J)
Alexandra Vappereau
(A)
Informations de copyright
© 2023 The Author(s).
Déclaration de conflit d'intérêts
NT, AD, CD, AR, GP, RCD, GR, FP, GK, VV, TM, HVK, ADLT, HK, RM, JFH, SD, JF, NBD, VKS, IDZ, HP, and GC declare no conflict of interest. MS reports consulting fees from Merit medical.
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