Zotarolimus-Eluting Peripheral Stents for the Treatment of Erectile Dysfunction in Subjects With Suboptimal Response to Phosphodiesterase-5 Inhibitors
What is the safety and feasibility of zotarolimus-eluting stent implantation in focal atherosclerotic lesions of the internal pudendal arteries among men with erectile dysfunction (ED) and a suboptimal response to phosphodiesterase-5 inhibitors?
Male subjects with atherosclerotic ED and a suboptimal response to phosphodiesterase-5 inhibitors were enrolled in this prospective, multicenter, single-armed safety and feasibility trial. A novel combination of clinical, duplex ultrasound, and invasive angiographic factors were used to determine eligibility for stent therapy. The primary safety endpoint was any major adverse event 30 days after the procedure. The primary feasibility endpoint was improvement in the International Index of Erectile Function (Erectile Dysfunction Domain) score ≥4 points in ≥50% of subjects at 3 months. The investigators reported 6-month follow-up results, including duplex ultrasound and angiography.
Forty-five lesions were treated with stents in 30 subjects. Procedural success was 100%, with no major adverse events through follow-up. The primary feasibility endpoint at 6 months was achieved by 59.3% of intention-to-treat subjects (95% confidence interval, 38.8%-77.6%) and 69.6% of per-protocol subjects (95% confidence interval, 47.1%-86.8%). Duplex ultrasound peak systolic velocity of the cavernosal arteries increased from baseline by 14.4 ±10.7 cm/s at 30 days and 22.5 ± 23.7 cm/s at 6 months. Angiographic binary restenosis (≥50% lumen diameter stenosis) was reported in 11 (34.4%) of 32 lesions.
The authors concluded that among patients with ED and limited response with pharmacologic therapy, percutaneous stent revascularization of the internal pudendal artery is associated with clinically meaningful improvement.
The current pilot study suggests that drug-eluting stent therapy for atherosclerotic ED in selected patients who have not responded to pharmacologic therapy is safe and feasible, can improve arterial inflow, and can result in improvement of ED. However, optimal patient selection will likely be crucial to the success of any endovascular approach. Patients with longstanding ED, veno-occlusive disease, or severe diffuse arterial disease are unlikely to benefit from endovascular therapies. Additional, larger randomized trials are needed to assess efficacy of this new technique against optimal pharmacological therapy and define potential candidates for revascularization therapy.
Keywords: Juvenile Hormones, Coronary Restenosis, Erectile Dysfunction, Drug-Eluting Stents, Phosphodiesterase 5 Inhibitors, Sirolimus, Stents
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