Safety and efficacy of Luminor™ balloon and Angiolite™ stent on TASC C/D tibial occlusive lesions in CLI patients: 12-month results. The MERLION trial.

Abstract

The aim of MERLION (NCT04073121) was to evaluate the outcomes of the mono or combination therapy of the iVascular Luminor™ drug-coated balloon (DCB) and Angiolite™ 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. 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. Fifty 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±9.5 cm. There was 100% technical success. There were 3/66 (4.5%) bailout stenting for severe flow limiting dissections. Twelve-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%. The iVascular Luminor™ DCB is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients from Singapore.