Two-year data from the SWING trial, a first-in-human study of the safety and performance of the Sundance sirolimus drug-coated balloon (DCB; Surmodics), have been presented at this year’s VEITHsymposium (14–18 November, New York, USA).
The SWING trial is a 35-patient prospective, multicentre, single-arm feasibility study to evaluate the safety and performance of the Sundance sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries. The SWING trial enrolled patients with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2–4mm, and a total lesion length of ≤230mm for treatment with the Sundance sirolimus DCB at eight sites in Australia, New Zealand, and/or Europe. Study patients will be followed for 36 months post index procedure.
The primary safety endpoint is defined as the number of patients with a composite of freedom from major adverse limb event (MALE) and perioperative death at 30 days following the index procedure. The primary efficacy endpoint is the rate of late lumen loss at six months, as assessed by quantitative vascular angiography. Both primary endpoints of the SWING trial were achieved.
Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major reintervention was reported among the 35 trial patients. The per protocol (PP) population reported an 8.3% rate of major adverse events (two clinically driven target limb revascularisations) at six months, with no additional adverse events reported for PP subjects in the 12 or 24-month data. Primary efficacy data show late lumen loss of 1mm (±0.79mm) across 35 lesions at six months, indicating that the large luminal gain achieved immediately after the procedure was sustained post procedure.
Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularisation associated with deterioration of Rutherford clinical classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >50%, was 71.4% at 24 months in the PP population. The Rutherford clinical classification describes seven categories of peripheral arterial disease, including both the patient’s clinical symptoms as well as objective findings, and is used to assess disease progression.
“The two-year safety and performance results of the SWING trial continue to show promise for the Sundance sirolimus DCB in treating below-the-knee disease in a challenging CLTI [chronic limb-threatening ischaemia] patient population where options are currently limited,” said Andrew Holden (Auckland City Hospital, Auckland, New Zealand), co-lead investigator, in a Surmodics press release.
“We need to continue to strive for better treatments for treating infrapopliteal disease,” added co-lead investigator Ramon Varcoe (Prince of Wales Hospital, Sydney, Australia), who presented the new data at VEITHsymposium 2023. “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”