Clinical and Imaging Outcomes up to 1 Year Following Balloon Angioplasty for Isolated Penile Artery Stenoses in Patients With Erectile Dysfunction: The PERFECT-2 Study

摘要

Purpose: To assess the angiographic and clinical outcomes in patients with erectile dysfunction and isolated penile artery stenoses treated by balloon angioplasty. Methods: In this prospective study, 22 patients (mean age 61.0 +/- 7.6 years, range 50-79) with erectile dysfunction and 34 isolated penile artery stenoses (mean 74.9%+/- 9.1%) were enrolled and underwent balloon angioplasty. The mean International Index for Erectile Function-5 (IIEF-5) score at baseline was 10.3 +/- 4.5. The mean lesion length was 11.1 +/- 9.0 mm (mean reference vessel diameter 1.7 +/- 0.4 mm). The primary endpoint was in-segment restenosis 50% by pelvic computed tomography angiography (CTA) at 8 months. The 1-year sustained clinical success (IIEF-5 score 22 or a 4-point change in the IIEF-5 score and no later decline by 4) was the secondary outcome measure. Results: Procedural success was achieved in 31 (91%) of 34 stenotic lesions; there was 1 flow-limiting dissection and 2 arteries with >30% residual stenosis. At 8 months, 14 of 34 lesions in 13 of 22 patients had CTA-documented binary restenosis. At 1 year, sustained clinical success was achieved in 11 of 22 patients. Of the 9 patients not developing binary restenosis, 8 achieved sustained clinical success. Conclusion: Our findings establish the safety and efficacy of penile artery angioplasty for patients with erectile dysfunction and isolated penile artery stenoses. They also highlight the unmet need for a more enduring treatment strategy for penile artery stenotic disease.