Penile artery angioplasty feasible for erectile dysfunction

PARIS — Penile artery angioplasty was associated with a success rate of around 60% in a cohort of patients with erectile dysfunction, according to findings from the PERFECT-1 study presented at EuroPCR.

The analysis was presented by Tzung-Dau Wang, MD, with the National Taiwan University Hospital, Taiwan, and included 198 consecutive patients with erectile dysfunction accrued from the university hospital between July 2012 and December 2013. Patients were aged 61 ± 9 years. Eighty percent had obstructive lesions (lesions, n=370) as evaluated by pelvic CTA.

The aim of the unblinded, single-arm, single-center, first-in-man prospective study was to assess the safety and durability of a catheter-based therapy for isolated penile artery stenoses. Wang noted that ≥70% were unilateral diameter stenoses and ≥50% bilateral diameter stenoses, and that eligible participants had an inadequate response to PDE-5 inhibitors. He added that an arteriogenic cause, primarily limited in the common penile artery segment, is the dominant pathogenic factor in patients aged ≥50 years with erectile dysfunction.

Tzung-Dau Wang

Zone 1 lesions occurred in 0.5% of the cohort, 4.6% were in zone 2, 8.4% were in zone 3, 41% were in zone 4 and 45% were in zone 5. Twenty-eight percent of patients had lesions limited in zone 5, or the penile artery, and 13% had lesions limited to zone 4, or the internal pudendal artery.

Change in IIEF-5 score from baseline to 6 months served as the primary feasibility endpoint. Any major adverse event within 1 month served as the key safety endpoint. For clinical success, the researchers evaluated for change of IIEF-5 score of ≥4 points from baseline or IIEF-5 ≥22.

The baseline IIEF-5 score was 10 ± 5.2. This score changed to 15.2 ± 6.7 (P<.001) at 1 month, 15.4 ± 6.9 (P<.001) at 3 months and 15.2 ± 6.3 (P<.001) at 6 months. “We identified a change in IIEF-5 score of 5.2 points,” Wang said.

There were no major adverse events at any of these time points. The clinical success rate was 75% at 1 month, 65% at 3 months and 60% at 6 months.

“For the PERFECT-1 study, for the first time we demonstrated the safety and feasibility of penile artery angioplasty in patients with erectile dysfunction,” Wang concluded. “The success rate is around 60% in those with isolated penile artery stenoses.” – by Rob Volansky

For more information:

Wang TD. Hot line: Trials and innovations for peripheral interventions. Presented at: EuroPCR; May 20-23, 2014; Paris.

Disclosure: Wang reports no relevant financial disclosures.