Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors

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

Research output: Contribution to journalArticle

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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. (Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED) (ZEN); NCT01643200).

Original languageEnglish (US)
Pages (from-to)2618-2627
Number of pages10
JournalJournal of the American College of Cardiology
Volume60
Issue number25
DOIs
StatePublished - Dec 25 2012

Fingerprint

Phosphodiesterase 5 Inhibitors
Erectile Dysfunction
Stents
Safety
Arteries
Therapeutics
Confidence Intervals
zotarolimus
Atherosclerosis
Angiography
Pathologic Constriction

Keywords

  • atherosclerosis
  • erectile dysfunction diagnosis
  • first-in-man
  • internal pudendal artery
  • zotarolimus-eluting stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors. / Rogers, Jason H; Goldstein, Irwin; Kandzari, David E.; Köhler, Tobias S.; Stinis, Curtiss T.; Wagner, Paula J.; Popma, Jeffrey J.; Jaff, Michael R.; Rocha-Singh, Krishna J.

In: Journal of the American College of Cardiology, Vol. 60, No. 25, 25.12.2012, p. 2618-2627.

Research output: Contribution to journalArticle

Rogers, Jason H ; Goldstein, Irwin ; Kandzari, David E. ; Köhler, Tobias S. ; Stinis, Curtiss T. ; Wagner, Paula J. ; Popma, Jeffrey J. ; Jaff, Michael R. ; Rocha-Singh, Krishna J. / Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors. In: Journal of the American College of Cardiology. 2012 ; Vol. 60, No. 25. pp. 2618-2627.
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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. (Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED) (ZEN); NCT01643200).",
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AU - Rogers, Jason H

AU - Goldstein, Irwin

AU - Kandzari, David E.

AU - Köhler, Tobias S.

AU - Stinis, Curtiss T.

AU - Wagner, Paula J.

AU - Popma, Jeffrey J.

AU - Jaff, Michael R.

AU - Rocha-Singh, Krishna J.

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N2 - 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. (Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED) (ZEN); NCT01643200).

AB - 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. (Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED) (ZEN); NCT01643200).

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KW - erectile dysfunction diagnosis

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