ABSTRACT
OBJECTIVE: To describe the 1-year outcomes of recurring infrapopliteal disease after endovascular revascularization with the Lutonix drug-coated balloons (LDCB) in diabetic patients with critical limb ischemia (CLI), and to benchmark our findings with previously published objective performance goals (OPG) addressing safety and efficacy of new catheter-based therapies for CLI. METHODS: The present study was a retrospective, single-center, and single-arm trial of symptomatic diabetic patients with CLI, who underwent LDCB-angioplasty for recurring infrapopliteal disease. Acute procedural and technical success were recorded. TcPO2 metrics variations at baseline and follow up were analyzed. Freedom from clinically driven target lesion revascularization (CD-TLR) was calculated using Kaplan-Meier analysis, and outcomes compared with previously published OPG for infrapopliteal interventions. RESULTS: 21 patients (15 men; mean age 66,6±11,2 years) were followed-up for 356.5±159.2 days and 90.47% had 12-months follow up data available for analysis. TcPO2 increased (14.3±11.6mmHg to 53.8±11.7mmHg; p<0.05). Limb salvage rate was 100%, and 90.4% of patients achieved the combined endpoint of reduction in ulcer size/depth or complete healing. LDCB had superior efficacy (MALE+post-operative death, amputation free survival, freedom from re-intervention, limb salvage and survival rates), while attaining superior or equivalent safety (Major Adverse Limb Events, major adverse cardiovascular events and Amputation) endpoints for the overall, modified clinical and anatomical high-risk groups. CONCLUSIONS: Lutonix DCB is safe and effective for recurring infrapopliteal disease. It outperforms the OPG for CLI patients with clinical and anatomical high-risk features.