To evaluate technical success, safety and efficacy of post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon (PCB) for revascularization of complex femoro-popliteal lesions. Thirty patients (26 male, mean age 70 ± 7 years) suffering from peripheral artery disease (PAD) (Rutherford category II–III) underwent revascularization of chronic total occlusions (n = 22, 73%) or severe stenosis (n = 8, 27%) of the femoro-popliteal segment. Mean lesion length was 251 ± 85 mm. Lesions were treated by pre-dilatation (POBA), implantation of a helical interwoven stent and post-dilatation with a PCB. Technical success was defined as residual stenosis < 30%. Follow-up included clinical visits, duplex ultrasound and ABI at 6 and 12 months. Endpoints were patency (re-stenosis < 50%), complications, improvement of Rutherford category and ABI. Regarding patency two sub-groups were compared: long-(“LL”; < 25 cm, n = 12, mean 175 ± 38 mm) and ultra-long lesions (“ULL”; ≥ 25 cm, n = 13, mean 322 ± 43 mm). Technical success was 100%. In 1/30 patients (3.3%), a minor complication occurred (embolism). The overall primary and secondary patency rates at 12 months were 80.0% (95% CI 72.5–96.9%) and 92.0% (95% CI 84.7–100%). In the LL-sub-group, primary patency was 100%, and in the ULL-sub-group, primary patency was 61.5% (95% CI 51.8–92.3%) (p = 0.056), and secondary patency 84.6% (95% CI 71.3–100%), respectively. Rutherford category increased by at least one category in 92% of patients, ABI increased from 0.52 ± 0.13 (baseline) to 0.9 ± 0.14 (12 months) (p = 0.001). Five patients underwent target lesion revascularization during follow-up (bypass: n = 1, endovascular: n = 4). No death was observed during follow-up. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated-balloon proved to be safe and effective with promising outcomes in long- and ultra-long lesions up to 12 months of follow-up.
Research Areas and Centers
- Academic Focus: Biomedical Engineering