Document Detail


Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors.
MedLine Citation:
PMID:  23177300     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: 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:
Jason H Rogers; Irwin Goldstein; David E Kandzari; Tobias S Köhler; Curtiss T Stinis; Paula J Wagner; Jeffrey J Popma; Michael R Jaff; Krishna J Rocha-Singh
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2012-11-21
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  60     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-21     Completed Date:  2013-02-19     Revised Date:  2013-08-15    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2618-27     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Affiliation:
Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento, California, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01643200
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Angiography
Dose-Response Relationship, Drug
Drug-Eluting Stents*
Erectile Dysfunction / diagnosis,  drug therapy,  surgery*
Feasibility Studies
Follow-Up Studies
Humans
Immunosuppressive Agents / pharmacology
Male
Middle Aged
Penile Erection / physiology*
Phosphodiesterase 5 Inhibitors / administration & dosage,  therapeutic use*
Prospective Studies
Prosthesis Design
Sirolimus / analogs & derivatives*,  pharmacology
Treatment Outcome
Ultrasonography, Doppler, Duplex
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Phosphodiesterase 5 Inhibitors; 0/zotarolimus; 53123-88-9/Sirolimus
Comments/Corrections
Comment In:
J Am Coll Cardiol. 2013 Jun 25;61(25):2569-70   [PMID:  23542101 ]
J Am Coll Cardiol. 2013 Jun 25;61(25):2569   [PMID:  23542113 ]
J Am Coll Cardiol. 2012 Dec 25;60(25):2628-30   [PMID:  23177299 ]

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