MedAlliance’s Selution SLR Sirolimus-Eluting Balloon Studied in PRESTIGE for Treatment of CLTI

October 6, 2021—Eighteen-month results were revealed from the PRESTIGE study that investigated performance outcomes and the safety profile of MedAlliance’s Selution sustained limus release (SLR) sirolimus-eluting balloon for treatment of TransAtlantic Inter-Society Consensus (TASC) II C and D tibial occlusive lesions in patients with chronic limb-threatening ischemia (CLTI). PRESTIGE is a pilot, prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study conducted in Singapore.

Tjun Tang, MD, presented the study findings during a late-breaking clinical trials session at the VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

The VIVA press release noted that the study originally included 25 patients (25 limbs; 33 lesions) with Rutherford class 5 wound severity. Of the 25 patients, 19 (76%) were available for 18-month analysis.

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

Dr. Tang reported that baseline demographics included 17 (68%) males and a mean age of 63.72 ± 9.73 years. Significant comorbidities included diabetes mellitus (n = 22; 88%) and end-stage renal failure (n = 11; 44%). Fifteen (45.5%) lesions were TASC II D, and mean lesion length treated was 19 ± 11 cm.

As summarized in the VIVA announcement, at the 18-month time point, AFS was 79.2% (19/24; four deaths and one major lower extremity amputation), the mortality rate was 16.7% (4/24), and freedom from CD-TLR was 88%.

Mean Rutherford class improved from 5.00 at baseline to 1.42 ± 2.1 (P < .05) at 18 months. The wound healing rate was 78.9% (15/19). Mean EQ-5D improved from 58.0 ± 9.57 at baseline to 75.5 ± 12.0 (P < .001) at 18 months. WIQ (distance) and WIQ (stairs) generally decreased, albeit insignificantly from baseline to 18 months.

The Selution SLR sirolimus-eluting balloon remains a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure; however, a trend of disease progression or recurrence was seen in medium-term outcomes, as reflected by worsening of the WIQ, concluded the study investigators in the VIVA press release.