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International Angiology 2021 May 31

DOI: 10.23736/S0392-9590.21.04690-3

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Physician initiated, prospective, non-randomized Multi-center trial, Investigating the safety and Efficacy of the TReatment with the LuminorTM Drug Coated Balloon and the AngioliteTM Drug Eluting Stent of IVascular in TASC C and D Tibial Occlusive disease iN patients with critical limb ischemia: 12-month results

Tjun Y. TANG 1, 2 , Charyl J. YAP 1, Sze L. CHAN 3, Shereen X. SOON 1, Chok T. LEE 4, Tze T. CHONG 1, Chuo R. LEONG 4

1 Department of Vascular Surgery, Singapore General Hospital, Singapore; 2 Duke-NUS Graduate Medical School, Singapore; 3 Health Services Research Center, SingHealth, Singapore; 4 Department of General Surgery, Khoo Teck Puat Hospital, Singapore


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BACKGROUND: The aim of MERLION (NCT04073121) was to evaluate the outcomes of the mono or combination therapy of the iVascular LuminorTM drug coated balloon (DCB) and AngioliteTM drug eluting stent for treatment of TASC II C/D tibial occlusive lesions in Asian patients presenting with chronic limb threatening ischemia (CLTI) from Singapore.
METHODS: MERLION was a prospective, non-randomized, single arm, observational, multicenter clinical study. Complication-free survival at one month was the safety endpoint. Immediate technical success, 12-month primary vessel patency, limb salvage, freedom from target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest.
RESULTS: 50 patients were included. There were 32 males (64% males; mean age 66.4±8.9 years). Majority were Rutherford 5 severity (41/50; 82%). Co-morbidities included diabetes mellitus (47/50; 94.0%), end-stage renal failure (25/50; 50.0%), and hypertension (44/50; 88%). 66 atherosclerotic lesions were treated (47 de novo and 19 restenotic; 60.6% TASC C and 39.4% TASC D). Mean lesion length treated was 13.7±9.5cm. There was 100% technical success. There were 3/66 (4.5%) bailout stenting for severe flow limiting dissections. 12-month primary tibial patency was 34/49 (69.4%) and freedom from TLR was 40/49 (81.5%). AFS was 74.0% (37/50). At 12 months, mean Rutherford scores improved from 100% (Rutherford score>3) at baseline to 31% at 12 months (p<0.05) and wound healing rate was 65.7%.
CONCLUSIONS: The iVascular LuminorTM DCB is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients from Singapore.


KEY WORDS: Paclitaxel; Drug-eluting stents; Drug-coated balloon; Limb salvage; Peripheral arterial disease

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