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Schweiger, L; Gütl, K; Rief, P; Reiter, C; Janisch, M; Weinberg, I; Kolluri, R; Miller, LE; Brodmann, M.
Retrievable Scaffold Therapy Combined with Sirolimus-coated Balloon Angioplasty for Infrapopliteal Artery Disease: Final Results from the DEEPER LIMUS Trial.
Cardiovasc Intervent Radiol. 2025; Doi: 10.1007/s00270-025-03987-y [OPEN ACCESS]
Web of Science PubMed FullText FullText_MUG

Leading authors Med Uni Graz: Schweiger Leyla
Co-authors Med Uni Graz: Brodmann Marianne; Janisch Michael August Johann; Kurzmann-Gütl Katharina; Reiter Clemens; Rief Peter
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Abstract:: PURPOSE: To evaluate the safety and efficacy of retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty for treating infrapopliteal artery lesions. METHODS: The DEEPER LIMUS study enrolled Rutherford class 3 to 5 patients with infrapopliteal artery disease. Patients underwent vessel preparation with retrievable scaffold therapy followed by sirolimus-coated balloon angioplasty. The primary safety outcome measure was a composite of all-cause mortality, major amputation, or clinically driven target lesion revascularization at 6 months. Secondary outcome measures included acute vessel recoil, perioperative death, angiographic late lumen loss between post-procedure and 6 months, as well as primary patency, major amputation, change in Rutherford class, and wound healing through 12 months. RESULTS: The study included 26 patients (mean age 71 years, 62% male, 88% Rutherford 5) with 28 treated infrapopliteal lesions (36% occluded, 54% TASC B/C). Acute vessel recoil, measured in seven patients, was negligible (2.4 mm after treatment vs. 2.3 mm 15 minutes after deployment). A 6-month primary safety event occurred in 11.5% of patients (1 all-cause mortality, 1 major amputation, 1 clinically driven target lesion revascularization). Late lumen loss at 6 months was 0.7±0.7 mm. At 12 months, primary patency was 89.5%, improvement in Rutherford class was observed in 68.2% of patients, 90% of patients were deemed very low/low major limb amputation risk based on Wound, Ischemia, and foot Infection (WIfI) scores, and no additional major amputations or clinically driven target lesion revascularizations were reported. CONCLUSIONS: Retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty demonstrated promising safety and efficacy through 12 months in patients with infrapopliteal artery disease. LEVEL OF EVIDENCE IV: Case Series.
Find related publications in this database (Keywords): Drug-coated balloon; Infrapopliteal; Retrievable scaffold therapy; Sirolimus