More Evidence Support PAE: Results of Sham Comparison
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COMMENTARY
COMMENTARY
More Evidence Support PAE: Results of Sham Comparison Marc Sapoval1 • T. Sabharwal2
Received: 9 March 2020 / Accepted: 29 April 2020 Ó Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020
In the recent issue of European Urology, Pisco and Bilhim report the results of a ‘‘Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia’’ [1]. They conducted a single-center randomized, singleblind, sham-controlled superiority clinical trial in 80 males with efficacy assessments at 6 and 12 months after randomization [1]. Patients were randomized 1:1 and after 6 months, all 38 patients randomized to the sham group who completed the single-blind period underwent prostatic artery embolization (PAE), and both groups completed a 6-month open period. The comparison to a sham procedure yields one of the strongest levels of evidence. Here it consisted in performing a complete PAE in the patient randomized to the active arm and to do a fake intervention in the patients randomize to the sham intervention arm (catheterization of one prostatic artery, wait for some minutes before the removal of the catheter and no particles injection). Based on an intention-to-treat analysis of all randomized patients at 6 m, patients in the PAE arm had a greater improvement in IPSS (International Prostate Symptom Score, a validated subjective evaluation of lower urinary tract symptoms related to Benign Prostatic Hyperplasia), with a difference in the change from baseline of 13.2 & Marc Sapoval [email protected] 1
Vascular and Oncological Interventional Radiology Department, Hoˆpital Europe´en Georges Pompidou, Inserm U 970, Paris, France
2
Department of Interventional Radiology, Guy’s and St Thomas Hospitals NHS Foundation Trust, London SE1 9RT, UK
(p \ 0.0001), and a better Quality of Life (QoL) score at 6 m (difference: 2.13; p \ 0.0001) than the patients in the sham arm. In addition, the improvements in IPSS and QoL in the sham group 6 m after PAE were, respectively, 13.6 ± 9.19 (p \ 0.0001) and 2.05 ± 1.71 (p \ 0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. This paper aims to resolve an important missing part to the large body of evidence supporting the clinical use of PAE in patients suffering from bothersome LUTS related to Benign Prostatic hyperplasia [2, 3]. This trial confirms that the number of patients still using alpha-blockers after PAE is minimal (5.1% in the PAE group vs. 91.9% in the sham group at 6 months (Table 5 suppl. material) and that it is indeed the embolization that decreases the urinary symptoms and not the added medical treatment. In addition, as addressed, in the comment by Abt et al., the results of PAE might even be underestimated by the use of alpha-blockers in the sham group [4]. It also alludes to the role of PAE on
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