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.

Background: 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.

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: 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%.

Conclusions: 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.