Sirolimus-eluting balloon successfully treats long lesions in patients with CLI
A sirolimus-eluting balloon was associated with high rates of amputation-free survival and wound healing and low rates of target lesion revascularization in patients with critical limb ischemia and long lesions, researchers reported.
For the PRESTIGE study, Tjun Tang, MD, FRCS, FAMS, senior consultant in vascular and endovascular surgery at Singapore General Hospital, and colleagues evaluated safety and performance outcomes of the drug-coated balloon (Selution SLR, MedAlliance) in 25 patients (mean age, 64 years; 68% men; 88% with diabetes; 44% with end-stage renal failure) from Singapore with Rutherford class 5 CLI with long (> 100 mm) tibial lesions (TASC II C or D) that were occluded or had stenosis of at least 50%. Patients were treated between October and December 2019.
“The sirolimus is bound within microreservoir polymers that allow, potentially, a sustained release of drug up to 90 days,” Tang said during a presentation at VIVA 22. “Also [the device] has a Cell Adherent Technology, which allows these microreservoirs to be safely delivered to the target and enhances bioavailability and absorption.”
The population reflects real-world practice in Singapore, as “patients present late” there, leading to many more patients with CLI being treated compared with claudicants, Tang said.
Technical success was 100% and there were no device- or procedure-related deaths at 30 days.
At 6 months, the rate of freedom from TLR was 92.6%; the rate of amputation-free survival was 84%, the rate of primary patency was 81.5% and the rate of wound healing was 81.8%, Tang said during the presentation, noting that the results were the same at 12 months other than the primary patency rate dropping to 77.8%.
At 18 months, during which there was no duplex ultrasound scan to evaluate patency, the rate of freedom from TLR was 88%, the rate of amputation-free survival was 79.2% and the rate of wound healing was 78.9%, Tang said.
At 24 months, the rate of freedom from TLR was 87%, the rate of amputation-free survival was 75% and the rate of wound healing was 94.4%, he said.
There were five deaths and one major amputation. Rutherford class improved by at least 1 at 24 months in 95% of patients, according to the researchers.
Improvement in EuroQol 5-dimension (EQ-5D) visual analogue scale was sustained to 24 months, whereas improvement in EQ-5D time trade-off Singapore score was sustained to 12 months, Tang said.
“The PRESTIGE trial at 24 months shows that the use of this sirolimus-coated balloon in our [CLI] patients, who are the most frail and challenging population of patients that we have in everyday practice, is relatively safe, has sustained efficacy and safety data and has sustained quality of life measures,” Tang said during the presentation. “There is some natural progression on recurrence of this disease. Could Selution be the solution for [below-the-knee] disease? We await the Selution4BTK randomized controlled study, which is currently recruiting.”
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Tang T, et al. Late-Breaking Clinical Trials. Presented at: VIVA 22; Oct. 31-Nov. 3, 2022; Las Vegas (hybrid meeting).
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