Head-to-head comparison of two paclitaxel-coated balloons for femoropopliteal lesions: 3-year results from the BIOPACT RCT

BACKGROUND: Over the past decade, drug-coated balloons (DCBs) delivering paclitaxel have become widely used for the treatment of peripheral artery disease (PAD). The safety and efficacy of various DCBs have been extensively studied, but differences in device design and drug delivery matrices may influence outcomes. The publication aim was to report long-term safety and efficacy data of the Passeo-18 Lux DCB for the treatment of symptomatic PAD due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries. METHODS: Three hundred and two patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or to the IN.PACT Admiral DCB (control device) group for testing of noninferiority. An efficacy endpoint was freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months. In terms of safety, a composite endpoint of freedom from device-/procedure-related death at 30 days post-index procedure, - major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) at 36 months was investigated. RESULTS: At 36 months, freedom from CD-TLR-was achieved in 119 out of 128 patients in the IN.PACT Admiral group (93.0%) and in 116 out of 127 patients in the Passeo-18 Lux group (91.3%). The null hypothesis of inferiority was rejected with a P value of 0.0095, confirming the non-inferiority of Passeo-18 Lux compared to IN.PACT Admiral in terms of efficacy. Both treatment groups demonstrated sustained clinical improvement, as shown by the evolution of the Rutherford Clinical Category (RCC). At 36 months, the mean change in target limb RCC class compared to baseline was -2.5 in both groups, indicating comparable and significant clinical improvement over time. CONCLUSIONS: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 36 months for femoropopliteal interventions.