MedAlliance’s Selution SLR Studied for Complex BTK Disease at 24 Months in PRESTIGE

November 4, 2022—The PRESTIGE study investigated the performance outcomes and safety of Selution SLR, a sustained limus release sirolimus-eluting balloon (MedAlliance SA) for the treatment of TASC II C and D tibial occlusive lesions in patients with chronic limb-threatening ischemia (CLTI). The prospective, nonrandomized, single-arm, multi-investigator, single-center clinical pilot study was conducted in Singapore.

Tjun Tang, MD, reported 24-month results during the third of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

According to the VIVA Foundation press release, 25 patients (25 limbs; 33 lesions) with Rutherford class 5 wound severity were originally included, and 18/25 (72%) patients were available for 24-month analysis.

Collected data included clinically driven target lesion revascularization (CD-TLR), amputation-free survival (AFS), change in Rutherford class, wound status, EQ-5D quality-of-life survey, and Walking Impairment Questionnaire (WIQ).

Baseline demographics included mean age of 63.7 ± 9.7 years and 17 males (68.0%). Significant comorbidities included diabetes mellitus (n = 22; 88.0%) and end-stage renal failure (n = 11; 44.0%). Fifteen patients had TASC II D lesions (45.5%), and mean lesion length treated was 19 ± 11 cm.

Dr. Tang reported the following findings at 24 months:

• AFS was 75% (18/24 patients; four deaths and two major lower extremity amputations).
• Freedom from CD-TLR was 87.0%.
• Mean Rutherford class improved from 5.00 at baseline to 0.44 ± 1.33 (P < .05).
• Wound healing rate was 94.4% (17/18).
• Mean EQ-5D visual analogue scale improved from 58.0 ± 9.57 at baseline to 76.7 ± 11.1 (P < .001).
• WIQ (distance) and WIQ (stairs) generally decreased insignificantly from baseline.

The PRESTIGE investigators concluded that the Selution SLR SEB remains safe and efficacious in treating complex tibial arterial occlusive lesions in this frail cohort of CLTI patients with a high prevalence of diabetes and end-stage renal failure. However, medium-term outcomes demonstrate a trend of disease progression or recurrence as reflected by worsening of the WIQ, noted the VIVA Foundation press release.