Safety and Efficacy of a Paclitaxel-Coated Balloon for the Treatment of Symptomatic Patients with Long Superficial Femoral Artery Disease.

Background: The clinical performance of drug-coated balloons (DCBs) for the treatment of femoro-popliteal lesions may depend on the specific device used. There is limited evidence on the clinical safety and efficacy of the paclitaxel-coated device Stellarex^® for the treatment of long (>180 mm) femoro-popliteal lesions.

Methods: This is a single arm, prospective, open label, observational study including symptomatic patients with long femoro-popliteal lesions undergoing endovascular revascularization with Stellarex^® DCB. The primary endpoints were the safety and efficacy of the DCB over time. Secondary endpoints were represented by functional outcomes.

Results: Ninety-five patients (median age 72, lesion length 250 mm) were included. At 6 months after the procedure, 61% of patients were asymptomatic as defined by the Rutherford classification, decreasing over time (57% at 12 months, 56% at 24 months, 44% at 36 months). Walking Impairment Questionnaire showed a remarkable improvement at 6 months, with a decreasing trend over time. When single components were analysed, better performances were observed for distance and climbing scores throughout the study period, while speed returned to baseline levels after 24 months. EQ5D Questionnaire showed a statistically significant improvement throughout the study period (with a decreasing trend over time, as seen for Rutherford classification and Walking Impairment Questionnaire). During the 36-months follow-up, 9% of patients died, with previous limb amputation being an independent predictor of mortality (HR = 7.4, p = 0.013). One-year primary patency was 76.5%, with no significant difference compared to the reference rate of 80% (p = 0.810). Primary patency defined as PSVR ≤2.4 (peak systolic velocity ratio) was maintained over time (median survival time free from PSVR >2.4 was not assessable as it exceeded the 36 months of follow-up).

Conclusion: In our sample, Stellarex showed to be safe and effective and it was associated with an event rate comparable to other devices reported in literature.