Not Necessarily PERFECT, but Drug-Eluting Balloon Shows Promise for Erectile Dysfunction
PARIS, France—Both drug-eluting balloons and conventional balloon angioplasty show potential for improving erectile function in patients with erectile dysfunction (ED) and penile artery stenosis, with similar rates of restenosis through 8 months with the two approaches.
Following-up on the rather high rates of restenosis observed with balloon angioplasty in patients with ED in PERFECT-2, which was presented at EuroPCR 2015, Tzung-Dau Wang, MD (National Taiwan University Hospital, Taipei, Taiwan), presented results of PERFECT-4 today at EuroPCR 2016.
The results “suggest not only the potential of endovascular therapy for penile artery stenosis in patients with erectile dysfunction, but also [support] the quest for more enduring treatment [strategies],” Wang said in his presentation.
The researchers randomized 44 patients at their center to treatment with the SeQuent Please paclitaxel-eluting balloon (B. Braun) or conventional balloon angioplasty between January 2013 and December 2014.
At 8 months, the rate of binary in-segment restenosis on CT (primary endpoint) was similarly high with both approaches (48% with drug-eluting balloons vs 40% with conventional angioplasty; P = 0.569). Clinical success—defined as a change in the International Index of Erectile Function-5 score ≥ 4 compared with baseline or a score ≥ 22—at 12 months was achieved in 50% and 59% of those in each group, respectively. There were no differences between the study groups in terms of diameter stenosis.
Binary restenosis was less likely to occur in patients who achieved clinical success at 12 months (P < 0.001) and nonsmokers (P = 0.015). Likewise, those who achieved sustained clinical success were less likely to develop binary restenosis (P < 0.001).
Wang said the underestimation of dissections stemming from the fact that balloon lengths are often longer than the lesions, as well as the need to use small-profile devices to maintain vascular integrity, “may explain the suboptimal midterm results of drug-eluting balloons for penile artery stenosis.”
In a panel discussion, Wang was asked about his process for dealing with occluded vessels. Although this only happens 10% to 15% of the time, he noted, balloon dilatation is advised. Also, although stents are available at lengths of 2 mm, Wang said past experience with them in the internal pudendal artery is “not so good,” with restenosis rates above about 50%.
With regard to medical therapy, Wang advises a three-pronged approach: clinical risk factor control, continued phosphodiesterase type 5 (PDE5) inhibitor use, and testosterone replacement.
Going forward, panelist Peter Fitzgerald, MD, PhD (Stanford University, California), said “working with the pharma companies is going to be key” to the future of the procedure. Maybe this intervention will make it so that patients still take a pill, but at a reduced dose, he suggested.
“What has stopped most of this from going on is the pharma companies and the power of how they get into the urologists. Once the urologists start to take CTs, they are seeing these vascular abnormalities, but it’s a tricky landscape to negotiate,” Fitzgerald continued. “Even if your results were much much better, you still have to work with the pharma companies. So I would not exclude them with a goal of getting off meds. I would include them with a goal of reduction of medication.”
Wang agreed. “We face the patients, and the patients may have high expectations about the results of this intervention,” he said. “I have to ask the patients to continue taking PDE5 inhibitors. The functional recovery may take time.” Patients often “misview” the procedure, he added—although simple, it relies on “concomitant success” along with the drugs.
Wang T-D. A randomized comparison between drug-eluting balloon and conventional balloon angioplasty for lesions in the penile artery in patients with erectile dysfunction: the PERFECT-4 study. Presented at: EuroPCR 2016. May 17, 2016. Paris, France.
- Wang reports no relevant conflicts of interest.