Six-month clinical outcomes of the MERLION trial were presented as part of the VIVA Late-Breaking Clinical Trials Livesteam (25 June), by Tjun Tang (Singapore General Hospital, Singapore).
MERLION is a physician initiated, prospective, non-randomised multicentre trial investigating the safety and efficacy of the treatment with the iVascular luminor drug-coated balloon (DCB) and angiolite below-the-knee (BTK) drug-eluting stent (DES) in TASC C and D tibial occlusive disease, in patients with chronic limb-threatening ischaemia (CLTI).
Tang reported a 100% technical success rate, with a 4.5% bailout stenting for severe flow limiting dissection using angiolite BTK, and a primary patency of 78.9%.
Freedom from clinically driven TLR was 91.7% while the amputation free survival (AFS) was 88%, both at six months. Tang concluded that the “luminor DCB is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in challenging CLTI patients” and he added that “luminor is associated with highly satisfactory acute technical success, six-month target lesion patency, and AFS.”