PERFECT-2: Angioplasty Can Effectively Treat Erectile Dysfunction But Restenosis an Issue

PARIS, France—Balloon angioplasty offers durable symptom relief in patients with erectile dysfunction and isolated penile artery stenosis for up to 1 year after treatment, according to late-breaking findings from the PERFECT-2 study presented May 20, 2015, at EuroPCR. However, restenosis developed 6 in 10 patients.

For the single-center study, a team led by Tzung-Dau Wang, MD, of National Taiwan University Hospital (Taipei, Taiwan), looked at 28 patients—all of whom had erectile dysfunction (score of 5-21 on the International Index of Erectile Function [IEFF]-5 questionnaire) and isolated penile artery lesions on CT angiography (CTA)—who underwent balloon angioplasty between December 2012 and January 2014. Full follow-up data were available for 22 patients (n = 34 lesions).

At baseline, mean age was 61 years. Mean IIEF-5 score was 10.1, with half of patients having either moderate (score 8-11; 9%) or severe (score 5-7; 41%) symptoms. Two-thirds (68%) had comorbid CAD. Four patients had bilateral disease, and 73% of lesions were located in the common penile artery. On CTA, the reference vessel diameter was 1.7 ± 0.4 mm. No lesions had calcification.

Promising, But Not PERFECT

Mean lesion stenosis increased from 76.9% at baseline to 9.5% post-angioplasty. Technical success (defined as diameter stenosis ≤ 30% with adequate distal runoff) was achieved in 97% of cases. Flow-limiting dissection occurred in 2 patients (6%). There were no access-site complications or cases of perineal hematoma.

At 6 to 9 months after treatment, values for minimal diameter, percent diameter stenosis, and lesion length all continued to be more favorable than at baseline (table 1).

Overall, 14 lesions (41%) showed evidence of binary restenosis (≥ 50% diameter stenosis). But Dr. Wang noted that on a per-patient basis, the rate of restenosis “was quite high” at 59%. Lesions with restenosis tended to occur in patients who were older (mean age 63 vs 59.1 years; P = .049) and in vessels with smaller reference diameter (mean 1.57 vs 1.81 mm; P = .06).

Nonetheless, 55% of patients still met the definition for clinical success (change in IIEF-5 score ≥ 4 compared with baseline or a score of ≥ 22 at follow-up) at 12 months. Patients with improved symptoms were more likely to be younger (mean 57.3 vs 65.3 years; P = .027) and had a lower prevalence of binary restenosis (33% vs 90%; P = .007). Thus, restenosis “was closely related to treatment failure,” Dr. Wang pointed out.

An “Unmet Need”

“Our findings highlight an unmet need for a more enduring treatment modality for penile artery stenotic diseases,” he concluded.

Panel member Nick Ossei-Gerning MBBS, MD, University Hospital of Wales (Cardiff, Wales) noted that this is not the first time this intervention has been attempted. “As you know in the 1980s, a few people were doing balloon angioplasty for erectile dysfunction and it was abandoned, primarily because of restenosis,” he commented. “Why do you think you are achieving better results now with just ‘plain old balloon angioplasty’”?

Dr. Wang said that one reason balloon angioplasty is used in this setting is because the penile artery is too small—at generally less than 2.0 mm—for other types of intervention. “The only tool I have is balloon angioplasty, or maybe a drug-eluting balloon,” he explained, though he did not elaborate on whether improvements in technology or some other factor could explain why the treatment appears to work better today than 30 years ago.

In an email, Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), told TCTMD that without more effective noninvasive screening to identify patients with penile artery lesions—and to pinpoint those whose lesions are causing their erectile dysfunction—this therapy is unlikely to become mainstream. Moreover, he added, “it seems to me that the rates of restenosis would be a further limiting factor here.”

Source: 
Wang T-D. Computed tomographic angiography follow-up and 12-month clinical outcome following balloon angioplasty for isolated penile artery stenoses in patients with erectile dysfunction: the PERFECT-2 study. Presented at: EuroPCR; May 20, 2015; Paris, France.

Disclosures:

• Dr. Wang reports no relevant conflicts of interest.