Stents Help Some Erectile Dysfunction
By medpagetoday.com
Stenting blocked arteries in the pelvis may improve sexual function for certain men with erectile dysfunction that is unresponsive to medical therapy, results of a pilot trial indicated.
Internal pudendal artery stenting boosted erectile function scores by a clinically-significant degree in 84% of the 19 men followed for 12 months after the procedure, Krishna J. Rocha-Singh, MD, of the Prairie Vascular Institute at St. John's Hospital in Springfield, Ill., and colleagues found.
Moreover, blood flow through the stented vessels remained durably improved without any safety concerns, the group reported here at the Transcatheter Cardiovascualar Therapeutics meeting.
These first-in-man results from the ZEN trial are promising for the highly-selected group of men in the pilot, Rocha-Singh suggested.
However, the approach faces a multitude of challenges, he told MedPage Today.
The ZEN trial sponsor, Medtronic, dropped their involvement and cancelled further planned studies.
The financial return on investment for any individual stent manufacturer may not be deemed sufficient for the small population of men with vascular erectile dysfunction when clinicians could use any competitor's coronary stent for the procedure, Rocha-Singh suggested.
Fully 92% of the men screened for the trial weren't candidates for the intervention -- primarily because the vascular disease was so advanced that there was nothing to open up, Rocha-Singh pointed out.
Angiographic or penile duplex ultrasound characteristics required for inclusion criteria were 70% or more stenosis in one side or 50% or more on both sides.
The 30 men who were included were typically older (average age 60), with a substantial proportion having cardiovascular risk factors such as a history of tobacco use (70%) or coronary events (20% prior heart attack, 13% prior stroke, and 7% prior unstable angina).
Catching men earlier may be key, Rocha-Singh proposed.
"It was all about the simple fact that we get men too late," he said. "Instead of stenting men in their 60s who've had bypass or carotid endarterectomy or femoral popliteal bypass, we need to ask them the first time they get on a phosphodiesterase inhibitor and ask them on a regular basis how is it working."
Half of men develop a suboptimal response to these drugs within 3 years and the options for those men aren't great, often leading to penile implants, he pointed out.
In previously reported results from the trial, the primary endpoints showed no major adverse events at 30 days (deaths, perineal gangrene or necrosis, or perineal, penile, or anal surgery) and a 59% rate of a clinically-meaningful improvement in the gold-standard measure of erectile function.
Among the 23 patients who stayed in the trial to 6 month follow-up reported by Rocha-Singh, the rate of four-point or greater improvement in the International Index of Erectile Function (IIEF) was 67%.
"I can't absolutely tell you that the patients didn't come back because they were happy they were having erections or if they were unhappy because they were already having penile implants," he told attendees at the session.
Absolute IIEF scores rose from a mean of 40 at baseline to 60 at 12 months.
Peak blood flow velocity in the cavernosal arteries through the penis showed improvements through 12 months, though, from a mean baseline of 16 cm/s to 32 cm/s.
No major adverse events were seen through 12 months.
While device companies haven't shown interest in further developing this indication for stents currently approved in the coronary heart disease setting, "that doesn't mean it's going to go away," Rocha-Singh noted, pointing to a research consortium that's getting organized in Europe around the procedure.
Source: http://www.medpagetoday.com/meetingcoverage/tct/35494