title: Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors.
abstract: OBJECTIVE
  This study sought to evaluate 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.
  
  
  BACKGROUND
  ED, a common condition, is often mediated by atherosclerosis. Current treatment options are limited.
  
  
  METHODS
  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 end point was improvement in the International Index of Erectile Function (Erectile Dysfunction Domain) score ≥ 4 points in ≥ 50% of subjects at 3 months. We report 6-month follow-up results, including duplex ultrasound and angiography.
  
  
  RESULTS
  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% to 77.6%) and 69.6% of per-protocol subjects (95% confidence interval: 47.1% to 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.
  
  
  CONCLUSIONS
  Among patients with ED and limited response with pharmacologic therapy, percutaneous stent revascularization of the internal pudendal artery is feasible and is associated with clinically meaningful improvement in both subjective and objective measures of erectile function.
authors.affiliation: Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, California, USA.
authors.forename: Jason H
authors.initials: JH
authors.lastname: Rogers
authors.forename: Irwin
authors.initials: I
authors.lastname: Goldstein
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.forename: Tobias S
authors.initials: TS
authors.lastname: Köhler
authors.forename: Curtiss T
authors.initials: CT
authors.lastname: Stinis
authors.forename: Paula J
authors.initials: PJ
authors.lastname: Wagner
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.forename: Krishna J
authors.initials: KJ
authors.lastname: Rocha-Singh
mesh_terms: D000328:Adult; D000368:Aged; D000792:Angiography; D004305:Dose-Response Relationship, Drug; D054855:Drug-Eluting Stents; D007172:Erectile Dysfunction / Q000175:diagnosis / Q000188:drug therapy / Q000601:surgery*; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000502:physiology*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex
chemical_list: D007166:Immunosuppressive Agents; D058986:Phosphodiesterase 5 Inhibitors; C489443:zotarolimus; D020123:Sirolimus