World's First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study

Abstract

Purpose: The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI.

Materials and methods: PRESTIGE is a pilot prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Endpoints were adverse event-free survival at 1 month, technical success rate, primary tibial patency at 6 months, limb salvage success, target lesion revascularization (TLR), and amputation free survival (AFS).

Results: A total of 25 patients were included. There were 17 (68.0%) males; mean age, 63.7±9.73 years. CLTI severity was based on the Rutherford scale (R5=25/25; 100.0%). Significant comorbidities included diabetes mellitus (n=22; 88.0%) and end-stage renal failure (n=11; 44.0%). A total of 33 atherosclerotic lesions were treated (TASC II D=15 (45.5%)). Mean lesion length treated was 191±111 mm. Technical success was 100%. Primary tibial patency at 6 months was 22/27 (81.5%) and freedom from clinically driven TLR was 25/30 (83.3%). AFS was 21/25 (84.0%; 3 deaths and 1 major lower extremity amputation). Mean Rutherford score improved from 5.00 at baseline to 1.14±2.10 (p<0.05) at 6 months. There was a wound healing rate of 13/22 (59.1%) and 17/21 (81.0%) at 3 and 6 months respectively.

Conclusions: Selution SLR drug-eluting balloon is 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. Technical and clinical success rates are high and 6-month target lesion patency and AFS are more than satisfactory.

Keywords: Selution SLR; chronic limb threatening ischemia; drug-coated balloon; limb salvage; outcome; percutaneous angioplasty; sirolimus; wound healing.

Figure 1.

PRESTIGE Trial flow diagram.

Figure 2.

(A) Cumulative incidence of target lesion revascularization (TLR) events estimated from competing events that preclude TLR, that is, amputation and death. (B) Survival probability for amputation-free survival (AFS) and death estimated using Kaplan-Meier analysis.

Figure 3.

Rutherford classification at baseline, 3 months, and 6 months. From 25/25 subjects assessed as (100%) Rutherford 5 at baseline, the percentage decreases to 56.5% at 3 months and finally 13.6% at 6 months. Eighteen of25 (81.8%) of subjects have shown improvement by at least 1 category by 6 months.

Figure 4.

EQ5D and Walking Impairment Questionnaire. (A) EQ5D TTO SG: EuroQol-5 Dimension Time Trade-Off Singapore; EQ-5D VAS: EuroQol-5 Dimension Visual Analogue Scale; Significant at p<0.05 when compared with baseline values. **p≤0.05. ^Values for EQ-5D TTO SG have been scaled up by a factor of 100 for illustrative purposes. (B) Significant at p<0.05 when compared with baseline values; * p≤0.05.

Figure 5.

An example of the wound healing course of a PRESTIGE enrolled patient. The patient presented with a 2-month history of a worsening left heel wound with a long occlusion of the left anterior tibial artery (ATA) and disease within the left dorsalis pedis artery (A). There was minor disease within the left peroneal artery (PA). The posterior tibial artery was completely occluded with no target vessel to aim for distally. Decision to open the left ATA. Once the chronic total occlusion (CTO) was crossed from an antegrade position, the lesion was prepared with 3 mm × 240 mm (proximally) and 2.5 mm × 80 mm (distally) high-pressure noncompliant plain balloons (Jade, OrbusNeich, Hong Kong) each for a duration of 3 minutes. Selution SLR DEB (drug-eluting balloon) (3 mm × 150 mm ×2 and 2.5 mm × 150 mm) were then applied to cover the whole lesion length from origin of ATA to DPA each for 2-minute duration to allow maximal drug transfer to the arterial wall. The PA was predilated with a 3-mm high-pressure noncompliant balloon and drugged with a 3 mm × 150 mm Selution SLR DEB. No slow phenomenon was noticed on the angiogram run afterward in either vessel. (B) The 6-month arterial duplex scan showing patency of both the ATA and PA each with a biphasic signal. (C) The wound healing course of the heel ulcer, which had completely healed by 3 months and had stayed closed at the 6-month follow up.