The use of a drug-eluting stent to treat erectile dysfunction (ED) is both feasible and safe, according to results from the ZEN trial published in the Journal of the American College of Cardiology. The first-in-man trial looked at a total of 30 men who were given one or more Zotarolimus-eluting stents to open unilateral or bilateral internal pudendal artery (IPA) lesions. The study protocol allowed no more than two stents per IPA and no more than four stents per patient.

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More than half of men, 59.3 percent, saw an improvement in ED as measured by an IIEF score improvement of four or more points at three and six months. A per-protocol analysis showed 68.2 percent of men with a four-point or greater IIEF improvement at three months and 69.6 percent at six months. The median IIEF score improvement was 12.5. All of the patients also met the primary safety endpoints — no major adverse events at 30 days related to either device or procedure.

"Among patients with ED and limited response to 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," concluded lead author Jason Rogers, MD, director of interventional cardiology at the University of California, Davis, Medical Center.

However, Rodgers notes that data from the trial are not sufficient to warrant widespread adoption of the new technique. "Defining appropriate patient selection undoubtedly will be crucial to the success of any endovascular approach. Randomized trials are needed to assess efficacy of this new technique against the best existing therapies," he said.

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