Original title: Zotarolimus-Eluting Peripheral Stents for the Treatment of Erectile Dysfunction in Subjects With Suboptimal Response to Phosphodiesterase-5 Inhibitors. Reference: Jason H. Rogers et al. J Am Coll Cardiol 2012. Article in press
Up to 52% of men between 40 – 70 years old present some degree of erectile dysfunction, and 50% of these men get a suboptimal response to sildenafil treatments. Coronary disease and erectile dysfunction share risk factors. In fact, 70% of men with documented coronary disease have erectile dysfunction.
Since balloon angioplasty has shown benefits, at least in the short term, this study was performed for the first time in men to assess the safety and feasibility of Zotarolimus DES in the treatment of erectile dysfunction with suboptimal response to sildenafil (ZEN trial).
Main inclusion criteria were insufficient response to sildenafil, reduced flow of the cavernosal artery at Doppler examination, and a severe lesion in one or both pudendal arteries at angiographic examination.
The International Index for Erectile Dysfunction, already validated by previous studies, was used to make comparisons before and after procedure. Primary safety end point was any adverse event at 30 days and feasibility end point was improvement of the International Index for Erectile Dysfunction at 3 months.
89 patients were considered, 30 of them finally fulfilled all criteria and received angioplasty with Zotarolimus eluting Resolute stent implantation in their pudendal artery (Medtronic, Santa Rosa, California). All patients reached the safety end point at 30 days and did not present adverse events at 6 months.
At 3 months, 68,3% of patients presented improvement of erectile dysfunction according to the International Index which continued at 6 months. A Doppler ultrasound showed the concurrent increase of penile flow. Binary restenosis at 6 months was 34,4%.
Conclusion
Angioplasty to the internal pudendal artery with Zotarolimus eluting stent implantation in patients with suboptimal response to sildenafil is safe and feasible; it can increase penile flow and improve erectile dysfunction.
Editorial Comment:
The absence of a control group and the small and selected population enrolled are limitations to this study. The International Index of Erectile Dysfunction, though valid, relies on multiple subjective parameters in patients that were not blind to the treatment they had received. It is also noted the difference in binary restenosis of the pudendal internal artery compared to a coronary of same diameter with the same device. Despite the above mentioned, the population that could benefit from this procedure is much larger than we believe, especially taking into account the absence of adverse events.
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