Abstract:
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.
journal_name
J Am Coll Cardioljournal_title
Journal of the American College of Cardiologyauthors
Rogers JH,Goldstein I,Kandzari DE,Köhler TS,Stinis CT,Wagner PJ,Popma JJ,Jaff MR,Rocha-Singh KJdoi
10.1016/j.jacc.2012.08.1016subject
Has Abstractpub_date
2012-12-25 00:00:00pages
2618-27issue
25eissn
0735-1097issn
1558-3597pii
S0735-1097(12)04936-4journal_volume
60pub_type
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journal_title:Journal of the American College of Cardiology
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更新日期:2012-01-03 00:00:00
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更新日期:2006-01-17 00:00:00
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更新日期:2008-11-04 00:00:00
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journal_title:Journal of the American College of Cardiology
pub_type: 临床试验,杂志文章
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更新日期:2012-06-19 00:00:00
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更新日期:1991-10-01 00:00:00
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