Petra Svarc (Rigshospitalet, Copenhagen, Denmark) presented during the scientific paper session at the European Conference on Embolotherapy (ET; 21–24 June, Valencia, Spain). She imparted on the audience the results of hers and colleagues’ double-blinded randomised controlled trial (RCT) of high-dose dexamethasone to reduce the symptoms of post-embolization syndrome (PES) in patients who had undergone prostate artery embolization (PAE; the DEXAPAE trial). The group’s findings were that 24mg of dexamethasone is “safe”, as the participants reported no side-effects, but that “it does not reduce PES following PAE” any more than “our standard treatment, which is paracetamol”.
PES is “an umbrella term for the systemic response to tissue necrosis,” Svarc began, detailing that it can include fever, influenza-like symptoms, local pain, and a worsening of lower urinary tract symptoms (LUTS). In a small number of PAE patients, PES can be severe and “mimic” urinary tract sepsis.
Theirs is the “first trial that examined [steroids’] efficacy” in reducing the inflammatory response of PES in PAE patients, Svarc went on. It was a single-centre, double-blinded RCT, where 31 participants were allocated 1:1 to receive either 24mg of dexamethasone or a placebo. Inclusion criteria included having LUTS secondary to benign prostate hyperplasia (BPH), a prostate volume >80ml, an International Prostate Symptom Score (IPSS) of eight or more, being eligible for catheter-based intervention, and having no contraindication to dexamethasone.
The primary outcomes assessed in the trial, Svarc noted, were morning rectal temperature at two days following PAE and pain severity and interference scores on the Brief Pain Inventory used for the first five days post-PAE. Secondary outcomes included hospital admission, levels of c-reactive protein (CRP) and acute urinary retention. “Most patients in both groups were subfebrile for all of the five days,” Svarc shared. Regarding pain, the scores were “generally low, and low means higher quality of life,” she added. The only significant difference regarding secondary outcomes, was the level of CRP—a mean of 108mg/l [range=54–161mg/l] in the control group vs. 10mg/l [5–33mg/l], p value<0.01 in the dexamethasone group.
Svarc then clarified for delegates why the trial ended after only 31 patients were randomised, when 60 had been recruited initially. The reasons were, she explained, that they saw no significant difference in primary outcomes and the control group had only mild PES symptoms.
In terms of conclusions, Svarc’s group found that 24mg of dexamethasone is safe, but does not help reduce PES symptoms following PAE. They also suggest based on their findings that mean temperature and pain may not warrant active treatment, “especially when we look at the control group”.