Multicentre UK registry results highlight embolization strengths and importance of physician experience

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Nigel Hacking

The first results from the UK-ROPE multicentre registry, presented at CIRSE 2017 in Copenhagen, Denmark, reveal that prostatic artery embolization is highly effective in reducing lower urinary tract symptoms in men with benign prostatic obstruction.

When compared directly with a matched cohort of men undergoing transurethral resection of the prostate (TURP), embolization was almost as effective as resection. Patients who underwent minimally invasive embolization stayed significantly fewer days in hospital compared to those who underwent TURP.

Nigel Hacking, a consultant interventional radiologist at University Hospital Southampton NHS Foundation Trust, Southampton, UK, presenting the results at the CIRSE annual meeting, said: “We have shown that prostatic artery embolization is safe and efficacious and [this procedure] really wins out on length of stay. The median length of stay after embolization is zero days compared with a median of two days with TURP. So for men who would rather avoid surgery, embolization is an excellent first option with likely economic benefits due to the day case nature of the procedure.”

UK-ROPE (Registry of prostate embolization) is the first multidisciplinary registry of prostatic embolization. It aimed to compare two cohorts of patients who underwent different treatments for lower urinary tract symptoms following benign prostatic hyperplasia: prostatic artery embolization and resection. The embolization arm had 216 patients; the resection arm included TURP (n=89) and holmium laser prostatectomy (HoLEP; n=13). The registry was designed as a non-inferiority study, ie, one that compares a novel treatment to an active treatment with a view to show that it is not clinically less effective with regards to a specified endpoint. The UK registry was jointly funded by the National Institute of Health and Care Excellence (NICE), the British Society of Interventional Radiology (BSIR), the British Association of Urological Surgeons (BAUS) and Cook Medical.

Investigators began recruiting in July 2014 and closed in January 2016. They enrolled 318 patients. The primary endpoint was the International Prostate Symptom Score (IPSS) score at 12 months. There were multiple secondary endpoints including length of stay; complication rates; reintervention rates; prostate volumes; flow studies; and erectile function after the procedures, diagnosed using the International Index of Erectile Function (IIEF-5).

The UK ROPE registry results show a significant improvement in 12 months for both groups. Embolization is clinically effective, producing a median 10-point improvement in IPSS. There was greater IPSS improvement in TURP cases, with a median 15-point IPSS improvement. “Propensity score analysis on 65 closely matched embolization/TURP patient-pairs support these findings. Embolization had “slightly worse” outcomes than TURP, but was still very effective,” said Hacking.

Similarly, the IPSS quality of life score showed that there was significant improvements in both groups at 12 months. There was greater quality of life improvement in TURP cases, “but the urologists and scientists have been very impressed with these results for embolization,” Hacking explained.

Results from the registry

  • Erectile function as measured by the IIEF-5 (that has a maximum score of 25), went up from a baseline of about 14.5 in both groups to 16.3 after embolization, and 14.8 in the TURP group at one year.
  • Urinary flow (Qmax) improved from baseline in both groups, but more in the TURP group. At baseline, the median score for embolization was 8.8 and at 12 months, it was 14.1. For TURP, baseline median Qmax was 10.4 and at 12 months, it was 22.3.
  • Residual volume in the embolization group was 161 at baseline and 129 at 12 months. Baseline values in the TURP group were 263 and at 12 months, they were 80.
  • There was a reduction in prostate size in both groups, with an average reduction of nearly 30% in the embolization group.
  • Embolization scored over TURP when it came to the time that patients took to return to normal; on average, this was about five days after embolization, as against 14 days after TURP.

Complications and reoperations
There was one blood transfusion, four haematomas, and one case of sepsis in the group that underwent embolization. This compared with no blood transfusions, or haematomas, but two cases of sepsis in the TURP group.

The reoperation rate for the embolization group was 5% within 12 months and 11.6% when planned operations after the 12-month period are taken into account. In the TURP group, within the 12-month period, the reoperation rate is 3.4% and just 1.1% after the 12-month period. The reoperation rate in the embolization group was slightly higher than reported in some other series. Prostatic artery embolization failures are mainly due to unilateral embolization, median lobe obstruction, or patient dissatisfaction despite IPSS improvement, Hacking said.

Patient reported complications included haematuria, haematospermia, and retrograde ejaculation (24% in the embolization group and 47% in the TURP group). These figures are likely to be inaccurate, due to the nature of a ‘questionnaire-based study’ as on direct questioning many of the men reporting retrograde ejaculation after embolization admitted that this symptom started after oral medication, months or years, before the prostatic artery embolization.

Commenting on the strengths of the data, he noted: “This was the first multicentre study, funded by multiple stakeholders, with an independent medical assessment unit. There was a free choice of embolic, and catheter/microcatheter. Still, this is non-randomised data, and the results would have been influenced by the learning curve for all but two participating centres who were being trained to perform prostatic artery embolization, even as they recruited to the registry as this is a difficult procedure with a clear learning curve. Also, the study had a 12-month endpoint, meaning that outcomes outside of this defined window will not form part of the analysis. We also used the original rather than the PErFecTED technique.”

New EURO-ROPE registry on the cards
Hacking also said that another multidisciplinary, multinational, multicentre registry of prostatic artery embolization, EURO-ROPE, is on the cards, potentially scheduled to begin recruiting in 2018. EURO-ROPE will have support from CIRSE and advice from key members of the European Association of Urology (EAU). It will be industry-sponsored and designed to rapidly collect data from 1,000 patients who will undergo embolization and then be followed for two years. “Participant centres are being trained and proctored in 2017, so that experienced teams of interventional radiologists and urologists will be involved in the data collection,” Hacking concluded.

 

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