Eighteen-month results from the PRESTIGE below-the-knee (BTK) study were presented as a late-breaking clinical trial at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA). The objective of this clinical investigation is to evaluate safety and performance outcomes of Selution SLR (MedAlliance), a novel sirolimus-eluting balloon for the treatment of long tibial occlusive lesions (TASC C and D) in patients with chronic limb-threatening ischaemia (CLTI).
Freedom from target lesion revascularisation (TLR) was exhibited by 88% of patients and 79% demonstrated amputation-free survival (AFS). The rate of wound healing was 79% and 79% of the patients improved their Rutherford score by at least one category. The 18-month results have been sustained from the six-month and 12-month data.
PRESTIGE is a prospective, single-centre, physician-initiated clinical study, run at the Singapore General Hospital (SGH) by Chong Tze Tec and Tang Tjun Yip. Twenty-five patients were enrolled with an average age of 64. Eighty-eight had diabetes mellitus and 44% had end-stage renal failure. No patients required bailout stenting. Clinical follow-up was at one, three, six, 12 and 18 months.
“We have observed minimal slow-flow phenomena, seen with other paclitaxel drug-eluting balloons. We have observed several cases of fast wound healing with Selution SLR. It is easy to track and deliver. We are looking forward to gaining further clinical experience with this device,” commented Chong.
“Singapore has a high percentage of diabetics in its population and CLTI therefore constitutes a major challenge among patients seen with peripheral arterial disease (PAD) who may benefit from this technology,” commented Tang. SGH performs over 1,000 interventional procedures a year on patients suffering from CLTI, according to a MedAlliance press release.
Selution SLR was awarded CE mark approval for the treatment of PAD in February 2020 and for the treatment of coronary arterial disease in May 2020. The US Food and Drug Administration (FDA) has awarded Selution SLR with four Breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral BTK and arteriovenous fistula indications.