LAS VEGAS — A sirolimus-coated balloon for treatment of peripheral artery disease was associated with positive outcomes at 2 years, according to new data from the SELUTION study presented at VIVA 19.
Among 50 patients treated with the device (Selution SLR, MedAlliance) in the first-in-human study, the rate of primary patency at 2 years was 81.7% in the intention-to-treat population and 94.4% in the per-protocol population, Thomas Zeller, MD, associate professor of angiology at Universitaets-Herzzentrum Freiburg, Bad Krozingen, Germany, said during a presentation.
Healio previously reported on the 6-month results, in which the target for late lumen loss was achieved.
A sirolimus-coated device may fill a need because of long-term mortality concerns around paclitaxel-coated devices, Zeller said.
“The only advantage of paclitaxel is that the coating of the balloon is easier to be managed with a paclitaxel solution,” he said. “Limus has a much more positive perception in the interventional cardiology community based on the coronary outcomes of drug-eluting stents. However, sirolimus elutes slowly and dilutes down to subtherapeutic levels quickly along the entire arterial wall. This device has microreservoirs, which achieve elution kinetics of sirolimus similar to best-in-class coronary drug-eluting stents. And a proprietary amphipathic lipid technology binds the microreservoirs to the balloon surface to guarantee a low amount of drug loss during insertion of the balloon.”
The 2-year rate of freedom from index limb amputation and clinically driven target lesion revascularization was 85.4%, whereas the 2-year rate of freedom from clinically driven TLR was 87.5%, he said, noting there were no primary TLR events after 11 months.
There were no deaths at 2 years, unlike in studies of other drug-coated devices for PAD, Zeller said. He added there were no cases of major or minor amputation.
“We cannot conclude that a sirolimus-eluting balloon is protective against dying during follow-up; however, at least there is no safety signal coming from this small study,” Zeller said during the presentation.
Between baseline and 2 years, 67% of patients improved by at least two Rutherford categories and 84% improved by at least one category, according to the researchers.
Mean ankle-brachial index improved from 0.75 at baseline to 0.97 at 2 years, whereas mean Walking Impairment Questionnaire distance score improved from 20.1 at baseline to 72.5 at 2 years, Zeller said. – by Erik Swain
Zeller T, et al. Late-Breaking Clinical Trials. Presented at: VIVA 19; Nov. 4-7, 2019; Las Vegas.
Disclosures: The study was funded by MedAlliance. Zeller reports he has financial ties with Bayer, B. Braun Medical, Biotronik, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, C.R. Bard, Intact Vascular, MedAlliance, Medtronic, Philips, Pluristem, QT Medical, Spectranetics, TriReme, Veryan, Vesper and W.L. Gore and Associates.