Guidance
4 Efficacy
4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A case series of 30 patients with atherosclerotic erectile dysfunction (ED) treated by zotarolimus‑eluting stents (45 lesions stented) reported international index of erectile function (IIEF; total scores range from 1 to 75, from worst to best) mean scores (±standard deviation [SD]) of 40.4 (±9.0, n=30) before the procedure and 52.9 (±15.8, n=28) 6 months after the procedure. At 6 months, 59% (16/27) of patients (95% confidence interval [CI] 39% to 78%) reported an improvement of 4 or more points on the IIEF‑6 questionnaire (scores range from 1 to 30, from worst to best).
4.2 A case series of 20 patients with ED and isolated penile artery stenosis treated by balloon angioplasty of the penile artery reported significant improvement in mean IIEF‑5 scores (scores range from 1 to 25, from worst to best) from 10.0 (±5.2) before the procedure to 15.2 (±6.3) after 6 months (change of +5.2 points, 95% CI 3.0 to 7.4, p<0.001). IIEF‑5 scores of 22 or higher were reported in none of the patients at baseline, in 20% (4/20) at 1 and 3 months, and in 15% (3/20) after 6 months. Clinical success (change in the IIEF‑5 score from baseline by 4 or more points or IIEF‑5 score of 22 or greater) was reported in 75% (15/20) of patients after 1 month, in 65% (13/20) after 3 months and in 60% (12/20) after 6 months.
4.3 The case series of 30 patients reported mean peak systolic velocities of the cavernosal arteries (±SD) of 16.4 (±8.1) cm/s before the procedure (n=14) and 42.0 (±26.9) cm/s after 6 months (n=23).
4.4 The case series of 30 patients reported restenosis (defined as more than 50% diameter stenosis on follow-up angiography) 6 months after the procedure in 33% (10/30) of patients (34% [11/32] of lesions, 95% CI 19% to 53%). Two of these 11 cases of restenosis were observed on non‑target lesions (left obturator artery and middle rectal artery, the latter of which occurred after stent migration).
4.5 The case series of 20 patients reported technical success (defined as residual diameter stenosis of 30% or less and adequate distal run-off) for all vessels treated (23/23).
4.6 The specialist advisers listed the following key efficacy outcomes: immediate angiographic evidence of opening of a stenosis at the time of the procedure, objective measures of improved flow (assessed by Doppler ultrasound or fractional flow reserve), improvement in ED assessed using the International Index of Erectile Function and Sexual Encounter Profile (SEP) 3, resolution of ED, and a sustained improved response to medical therapy for ED (phosphodiesterase-5 inhibitors).